Over-the-scope clip (OTSC) represents an effective endoscopic treatment for acute GI bleeding after failure of conventional techniques

Background

Through-the-scope clips are commonly used for endoscopic hemostasis of gastrointestinal (GI) bleeding, but their efficacy can be suboptimal in patients with complex bleeding lesions. The over-the-scope clip (OTSC) could overcome the limitations of through-the-scope clips by allowing compression of larger amounts of tissue, allowing a more efficient hemostasis. We analyzed the use of OTSC in a consecutive case series of patients with acute GI bleeding unresponsive to conventional endoscopic treatment modalities.

Methods

In a retrospective analysis of prospectively collected data in tertiary referral centers, patients undergoing emergency endoscopy for severe acute nonvariceal GI bleeding were treated with the OTSC after failure of conventional techniques. All patients underwent repeat endoscopy 2–4 days after the procedure. Data analysis included primary hemostasis, complications, and 1-month follow-up clinical outcome.

Results

During a 10-month period, 30 patients entered the study consecutively. Bleeding lesions unresponsive to conventional endoscopic treatment (saline/adrenaline injection and through-the-scope clipping) were located in the upper and lower GI tract in 23 and 7 cases, respectively. Primary hemostasis was achieved in 29 of 30 cases (97 %). One patient with bleeding from duodenal bulb ulcer required emergent selective radiological embolization. Rebleeding occurred in two patients 12 and 24 h after the procedure; they were successfully treated with conventional saline/adrenaline endoscopic injection.

Conclusions

OTSC is an effective and safe therapeutic option for severe acute GI bleeding when conventional endoscopic treatment modalities fail.     

Management of intraoperative hemorrhage during NOTES®: a prospective, randomized comparison

Background

The optimal strategy to manage intraoperative hemorrhage during NOTES^® is unknown. A randomized comparison of three instruments for hemorrhage control was performed [prototype endoscopic bipolar hemostasis forceps (BELA) vs. prototype endoscopic clip (E-CLIP) applier versus laparoscopic clip (L-CLIP) applier].

Methods

A hybrid transvaginal NOTES model in swine was used, with hemorrhage induced in either the gastroepiploic (GE) arteriovenous bundle (vessel diameter ~3 mm) or in distal mesenteric vessels (vessel diameter ~1–2 mm). Hemostasis was attempted three times per vessel using each instrument in a randomized order. Full laparoscopic salvage was performed if hemorrhage persisted beyond 10 min. Outcomes included primary success rate (PS), primary hemostasis time (PHT), number of device applications (DA), and overall hemostasis time (OHT, including salvage).

Results

Seventy hemostasis attempts were made in 12 swine. PS was 42–67 % for the GE vessels, with no difference between instruments. PHT and OHT also were similar between instruments, with the BELA and L-CLIP having a higher number of DA. PS was (80–100 %) in mesenteric vessels, with the BELA and L-CLIP resulting in a shorter mean PHT compared with the E-CLIP.

Conclusions

All three instruments had similar effectiveness in achieving primary hemostasis during hybrid NOTES. Management of small vessel bleeding (1–2 mm) in a porcine model is effective using all three instruments but may be most efficient with the BELA or L-CLIP. Large vessel bleeding (≥3 mm) may be best managed by adding laparoscopic ports for assistance while maintaining a low threshold for conversion to full laparoscopy.     

Hemostatic efficacy of latest-generation fibrin sealant after hepatic resection: a randomized controlled clinical study

Purpose

This randomized, controlled, single-blinded multicenter study evaluated the efficacy of latest-generation fibrin sealant containing synthetic aprotinin as fibrinolysis inhibitor as supportive treatment for hemostasis after elective partial hepatectomy.

Methods

Adult subjects undergoing resection of at least one liver segment were assigned to treatment with fibrin sealant or manual compression with a surgical gauze swab if persistent oozing necessitated additional hemostatic measures after primary control of arterial and venous bleeding. The primary outcome measure was the proportion of subjects with intraoperative hemostasis at 4 min after start of randomized treatment application. Secondary efficacy outcome measures included intraoperative hemostasis at 6, 8, and 10 min, intra- and postoperative rebleedings, transfusion requirements, and drainage volume.

Results

Seventy subjects were randomized. Hemostasis at 4 min was achieved in 29/35 (82.9 %) fibrin sealant subjects compared with 13/35 (37.1 %) control subjects (p?p?p?=?0.028), and 10 min (p?=?0.017). The number of rebleedings was low in both study arms. Transfusion requirements and 48-h drainage volumes were similar between the study arms. No adverse events related to study treatment were reported.

Conclusions

Fibrin sealant was shown to be safe and superior to manual compression in the control of parenchymal bleeding after hepatic resection. The use of synthetic aprotinin as fibrinolysis inhibitor further improves the safety margin of fibrin sealant by eliminating the risk of transmission of bovine spongiform encephalopathy and other bovine pathogens.     

The Clinical Utility of Over-the-Scope Clip for the Treatment of Gastrointestinal Defects

Background

The over-the-scope clip (OTSC) is a novel endoscopic tool that enables non-surgical management of gastrointestinal (GI) defects. The aim of this study was to report our experience with OTSC for patients with GI defects.

Methods

A prospectively maintained IRB-approved institutional database was queried for all patients treated with OTSC from 2012 to 2015. Primary outcome was the clinical success of the OTSC for the individual indication. Secondary outcome was the number of additional procedures needed following OTSC.

Results

Fifty-one patients were treated with OTSC: upper GI (UGI) 30 and lower GI (LGI) 21. GI leak (n?=?24; UGI?=?12, LGI?=?12) and fistulae (n?=?17; UGI?=?8, LGI?=?9) were the most common indications. Overall success rate for the treatment of leaks was 59 % [UGI 66 % vs. LGI 33 % (p?=?0.1)]. A lower success rate (35 %) was noted for fistulae [UGI 62 % vs. LGI 0 % (p?=?0.001)]. Success rates for UGI perforation, bleeding, and stent anchoring indications were 75, 75, and 50 %, respectively. Additional endoscopic or surgical interventions following OTSC were indicated in 68.6 % of the patients.

Conclusions

OTSC appears to have additional value in treating UGI defects. However, lower success rates for LGI defects were noted, specifically for fistulae. Most patients require an additional endoscopic or surgical procedure after one OTSC application.

     

Metabolic evaluation of patients with urinary system stone disease: a research of pediatric and adult patients

Objectives

To determine the metabolic risk factors in children and adults with urinary system stone disease.

Materials and methods

Between September 2008 and February 2011, 257 patients who underwent 24-h urine analysis because of urinary system stone disease were included in the present study. Group I and II include only adult patients. The first-time stone formers were named as Group I (n = 106), and recurrent stone formers were named as Group II (n = 107). Group III was occurred by pediatric patients (n = 44). Control group includes 105 people was called as Group IV. This group was divided into two subgroups. Group IVa includes 70 adult people, and Group IVb includes 35 children. The metabolic evaluation results of patients and control groups were compared.

Results

Hypercalciuria (35.8, 44.9, and 47.7 % for Group I, II, and III, respectively) and hypocitraturia (42.5, 40.2, and 50 % for Group I, II, and III, respectively) were most common risk factors for stone formation. However, unlike the literature, we have seen that hypomagnesiuria is also an important risk factor in adults and children. Hypomagnesiuria was defined at 36.4 % in Group I, 29 % in Group II, and 56.8 % in Group III (p < 0.05 for each group). These three parameters were significantly different between patient and control groups.

Conclusions

Hypomagnesiuria, hypocitraturia, and hypercalciuria are the most important risk factors for stone formation in adults and pediatric patients.     

Gastro-tracheal fistula - unusual and life threatening complication after esophagectomy for cancer: a case report

Purpose

The aim of this study is evaluate the efficacy of TachoSil^® patches in controlling suture-hole bleeding after elective infrarenal abdominal aortic aneurysm (AAA) replacement with Dacron graft.

Materials and methods

Patients undergoing elective replacement of infrarenal AAA with Dacron grafts were prospectively randomized to TachoSil^® patches (Group I) or standard compression with surgical swabs (Group II). We evaluated time to haemostasis, blood loss during the operation, blood loss after cross-clamp removal, duration of operation, drain volume, requirement for blood transfusion and surgeons rating of efficacy.

Results

Twenty patients were randomized (10 patients in each treatment Group). The mean time to haemostasis was 264 ± 127.1 s (range: 180-600 s) in Group I and 408 ± 159.5 s (range: 120-720 s) in Group II (p = 0.026); mean blood loss during the operation was 503.5 ± 20.7 cc (range: 474-545 cc) in Group I and 615.7 ± 60.3 cc (range: 530-720 cc) in Group II (p < 0.001); mean blood loss after cross-clamp removal was 26.5 ± 4 g (range: 22-34 g) in Group I and 45.4 ± 4.6 (range: 38-52 g) in Group II (p < 0.001) and mean drain volume was 116.7 ± 41.4 cc (range: 79-230 cc) in Group I and 134.5 ± 42.8 cc (range: 101-250 cc) in Group II (p = 0.034). There were no serious adverse events associated with use of TachoSil^® patches.

Conclusion

For patients undergoing aortic reconstruction with Dacron grafts, TachoSil^® patches were found to be safe and effective for the control of suture-hole bleeding.     

Impact of renal graft nephrectomy on second kidney transplant survival

Purpose

To determine the impact of non-functional renal graft nephrectomy on second kidney transplantation survival.

Methods

We performed a retrospective study on patients managed in our department from April 1989 to April 2011. We compared the number of acute graft rejections and graft survival between patients undergoing second transplantation with (Group I) or without (Group II) prior graft nephrectomy.

Results

A total of ninety-one patients received a second renal graft: 43 underwent graft nephrectomy and 48 kept their non-functional renal graft. There were 5 episodes of acute graft rejection in Group I and 12 in Group II (p = 0.3). Six (13.9 %) grafts failed in Group I and eight (16.6 %) in Group II. Five and 10 years actuarial graft survival in Group I were, respectively, 91 and 85 %, while in Group II were 82.7 % and 69 % (p = 0.2). PRA level and number of acute rejection episodes did not have a statistically significant influence on graft survival, whether the patient had a nephrectomy or not (p = 0.2).

Conclusion

Nephrectomy of a failed allograft did not significantly improve the survival of a subsequent graft. Graft nephrectomy should be indicated in case of graft-related pain or a chronic inflammation syndrome.     

Postprocedural combined treatment using the coagulation plus artery-selective clipping (2C) method for the prevention of delayed bleeding after ESD

Background

The incidence of delayed bleeding after endoscopic submucosal dissection (ESD) for gastric neoplasms is reported to be approximately 5 %. We examined whether postprocedural combined treatment using the coagulation plus artery-selective clipping (2C) method is a useful measure for preventing delayed bleeding after ESD.

Methods

A total of 234 gastric epithelial neoplasms were treated from June 2007 to May 2012. Post-ESD coagulation (PEC) and clipping for part of the vessels was performed for 154 lesions from June 2007 to June 2010. A total of 80 lesions were treated using the 2C method from July 2010 to May 2012. During ESD, the locations of the arteries were recorded on a schematic diagram of the lesion. Arteries were defined as regions of arterial bleeding that required coagulation or apparent arteries in which preventive coagulation was performed. When ESD was completed, soft coagulation was performed for arteries in the resection area using hemostatic forceps, followed by arterial clipping for additional strength. Coagulation also was performed continuously for visible vessels in the resection area. This was a retrospective study. The incidence rates of delayed bleeding after ESD, as evidenced by hematemesis or melena, or the presence of anemia (decline in Hb >2 g/dl) that required emergency endoscopy were recorded.

Results

Delayed bleeding occurred in 7 (4.5 %) of the 154 cases treated using PEC and in 1 (1.3 %) of the 80 cases treated using the 2C method. The mean time required for the 2C method was 15.0 ± 7.0 min (range, 5–44 min). The mean number of clippings per lesion was 3.8 ± 2.8 (range, 0–13). Almost all clips fell off within 2 months of the procedure.

Conclusions

Coagulation plus artery-selective clipping (the 2C method) of post-ESD ulcers might effectively reduce the incidence of delayed bleeding after ESD for gastric neoplasms.     

Sedation for interventional gastrointestinal endoscopic procedures: are we overlooking the “pain”?

Background

Although interventional gastrointestinal (GI) endoscopic procedures are known to cause greater pain and discomfort than diagnostic procedures, the efficacy of adequate pain control or the difference in pain and amount of analgesic required according to type of intervention is not well known. This study was done to investigate the safety and efficacy of combining fentanyl with propofol for interventional GI endoscopic procedures and determine whether this method is superior to propofol monosedation.

Methods

The data of 810 patients that underwent interventional GI endoscopic procedures under sedation with either propofol alone (Group P, n = 499) or propofol/fentanyl (Group PF, n = 311) at a single tertiary-care hospital between May 2012 and December 2012 were retrospectively reviewed. Rates of respiratory and cardiovascular events, propofol and fentanyl requirements, and risk factors of respiratory events of the two groups were analyzed.

Results

The incidence of respiratory events (P = 0.001), number of cases in which the procedure had to be interrupted for assisted mask bagging (P = 0.044), and propofol infusion rates were significantly lower in Group PF compared to Group P (P < 0.0001). The amount of fentanyl required for diagnostic procedures was significantly lower than that for interventional procedures (P < 0.001). Patients of Group PF showed a lower risk of developing respiratory events compared to Group P (OR 0.224, 95 % CI 0.069–0.724).

Conclusions

Combining fentanyl with propofol seems to reduce the risk of respiratory events compared with propofol monosedation during GI endoscopic procedures by providing effective analgesia.     

Clinical outcomes of second-look endoscopy after gastric endoscopic submucosal dissection: predictive factors with high risks of bleeding

Background

A second-look endoscopy is routinely performed after endoscopic submucosal dissection (ESD) in many institutions, although the need is questionable. Additional hemostatic procedures might be necessary for the post-ESD ulcer with a high risk of bleeding. We investigated the predictive factors for post-ESD ulcers with a high risk of bleeding.

Methods

Second-look endoscopy was performed on the day following ESD. The post-ESD ulcers were categorized into two risk groups according to the Forrest classification: high-risk ulcer stigma (type I and IIa) and low-risk ulcer stigma. We analyzed the risk factors associated with high-risk ulcer stigma and late delayed bleeding.

Results

During the study period, 616 ESD procedures were performed. Second-look endoscopy revealed that the incidence of high-risk ulcer stigma post-ESD was 15.1 %. Early and late delayed bleeding rates were 3.7 and 1.9 %, respectively. Multivariate analysis revealed that submucosal fibrosis and nausea were significantly related to high-risk ulcer stigma after ESD. Multivariate analysis revealed that surface erosion, location of the lesion, and high-risk ulcer stigma identified by second-look endoscopy were significantly associated with late delayed bleeding.

Conclusions

The effective use of selective second-look endoscopy will help limit unnecessary procedures. Submucosal fibrosis and nausea were risk factors associated with high-risk ulcer stigma after ESD.     

Endoscopic hemostasis for peptic ulcer bleeding: systematic review and meta-analyses of randomized controlled trials

Background

Peptic ulcer represents the most common cause of upper gastrointestinal bleeding. Endoscopic therapy can reduce the risks of rebleeding, continued bleeding, need for surgery, and mortality. The objective of this review is to compare the different modalities of endoscopic therapy.

Methods

Studies were identified by searching electronic databases MEDLINE, Embase, Cochrane, LILACS, DARE, and CINAHL. We selected randomized clinical trials that assessed contemporary endoscopic hemostatic techniques. The outcomes evaluated were: initial hemostasis, rebleeding rate, need for surgery, and mortality. The possibility of publication bias was evaluated by funnel plots. An additional analysis was made, including only the higher-quality trials.

Results

Twenty-eight trials involving 2988 patients were evaluated. Injection therapy alone was inferior to injection therapy with hemoclip and with thermal coagulation when evaluating rebleeding and the need for emergency surgery. Hemoclip was superior to injection therapy in terms of rebleeding; there were no statistically significant differences between hemoclip alone and hemoclip with injection therapy. There was considerable heterogeneity in the comparisons between hemoclip and thermal coagulation. There were no statistically significant differences between thermal coagulation and injection therapy, though their combination was superior, in terms of rebleeding, to thermal coagulation alone.

Conclusions

Injection therapy should not be used alone. Hemoclip is superior to injection therapy, and combining hemoclip with an injectate does not improve hemostatic efficacy above hemoclip alone. Thermal coagulation has similar efficacy as injection therapy; combining these appears to be superior to thermal coagulation alone. Therefore, we recommend the application of hemoclips or the combined use of injection therapy with thermal coagulation for the treatment of peptic ulcer bleeding.

     

A prospective study comparing bipolar endoscopic enucleation of prostate with bipolar transurethral resection in saline for management of symptomatic benign prostate enlargement larger than 70 g in a matched cohort

Purpose

This study aims to compare the efficacy and safety of bipolar endoscopic enucleation of prostate with transurethral resection in saline for large BPE greater than 70 g.

Methods

All patients from two urology centres who had bipolar enucleation or bipolar resection performed for large BPE greater than 70 g from December 2008 to April 2012 were prospectively assessed. The pre-operative and post-operative measures included IPSS, QOL score, uroflowmetry results, PSA and prostate volume. The perioperative measures were compared, and the post-operative complications/resumption of medical treatment for lower urinary tract symptoms were also assessed.

Results

There were 74 and 86 consecutive patients with bipolar enucleation and bipolar resection performed, respectively. No difference in pre-operative characteristics was observed between the two groups with mean prostate size 115 cc in each group. Comparing bipolar enucleation with bipolar resection, there was longer operative time (156 vs 87 min, p = 0.000), more haemoglobin drop (1.8 vs 1.1 g/dL, p = 0.006), but more prostate tissue resected (61.4 vs 45.7 g, p = 0.000). There was no difference in overall transfusion requirement and hospital stay. At 12 month after the procedure, patients with bipolar enucleation performed had better IPSS (6.4 vs 11.6, p = 0.032), QOL (1.7 vs 2.6, p = 0.040) and peak flow rate (19.5 vs 15.1 ml/s, p = 0.019). The post-operative complications had no significant difference between the two groups.

Conclusions

For surgical treatment of big BPE, bipolar endoscopic enucleation of prostate provided superior functional outcome than bipolar resection but required longer operative time.     

Bleeding and hemostasis in laparoscopic liver surgery

Background

Minimally invasive liver resection is gaining acceptance worldwide. However, the laparoscopic approach often is reserved for small segmental resections due to the fear of significant blood loss. The expansion of laparoscopic liver surgery will depend on the ability of expert surgeons and technological advances to address the management of bleeding and hemostasis with any new approach. The 4½- year experience of a single center performing totally laparoscopic liver resections is presented, with special reference to the techniques the authors have developed to limit blood loss.

Methods

Between 2003 and 2007, 80 patients underwent laparoscopic liver surgery for benign and malignant conditions including colorectal cancer metastases (n = 31), hepatocellular carcinoma (n = 6), neuroendocrine tumor (n = 3), cystic lesion (n = 10), adenoma (n = 8), and focal nodular hyperplasia (n = 7). Totally laparoscopic resections included sectionectomy (n = 27), hemihepatectomy (n = 10), and single/multiple segmentectomies (n = 21). Data for all resections were recorded and analyzed retrospectively to assess blood loss, hospital stay, and morbidity.

Results

The median operative time was 150 min, and the median blood loss was 120 ml, with significantly more blood loss for right-sided transections than for the left liver surgery (821 vs 147 ml; p = 0.012). Four (57%) of seven resections converted to open procedures because of bleeding. No deaths occurred, and only two patients required intraoperative blood transfusions. There were eight complications and one bile leak. The median length of hospital stay was 3 days.

Conclusions

The authors’ experience with 80 totally laparoscopic liver resections over a 4½-year period demonstrates that laparoscopic liver surgery is safe and effective in experienced hands for major resections. An intimate knowledge of the technology and techniques available for preventing and managing significant hemorrhage during laparoscopic liver resection is required for all surgeons performing laparoscopic liver surgery.     

Randomized controlled multicenter trial on the effectiveness of the collagen hemostat Sangustop® compared with a carrier-bound fibrin sealant during liver resection (ESSCALIVER study,NCT00918619)

Background

Despite improvements in liver surgery over the past decades, hemostasis during hepatic resections remains challenging. This multicenter randomized study compares the hemostatic effect of a collagen hemostat vs. a carrier-bound fibrin sealant after hepatic resection.

Methods

Patients scheduled for elective liver resection were randomized intraoperatively to receive either the collagen hemostat (COLL) or the carrier-bound fibrin sealant (CBFS) for secondary hemostasis. The primary endpoint was the proportion of patients with hemostasis after 3 min. Secondary parameters were the proportions of patients with hemostasis after 5 and 10 min, the total time to hemostasis, and the complication rates during a 3 months follow-up period.

Results

A total of 128 patients were included. In the COLL group, 53 out of 61 patients (86.9 %) achieved complete hemostasis within 3 min after application of the hemostat compared to 52 out of 65 patients (80.0 %) in the CBFS group. The 95 % confidence interval for this difference [?6.0 %, 19.8 %] does not include the lower noninferiority margin (?10 %). Thus, the COLL treatment can be regarded as noninferior to the comparator. The proportions of patients with hemostasis after 3, 5, and 10 min were not significantly different between the two study arms. Postoperative mortality and morbidity were similar in both treatment groups.

Conclusion

The collagen hemostat is as effective as the carrier-bound fibrin sealant in obtaining secondary hemostasis during liver resection with a comparable complication rate.     

Foreign material erosion after laparoscopic Roux-en-Y gastric bypass: findings and treatment

Background

Patients after laparoscopic Roux-en-Y gastric bypass (LRYGB) can have nonspecific, upper gastrointestinal (UGI) complaints. During postoperative endoscopy, we have noted the erosion of nondissolvable material, such as Peri-Strips® or silk sutures, into the gastric pouch. This study reports the incidence and presentation of foreign material erosion into the gastric pouch after a LRYGB and the outcome after therapeutic endoscopy.

Methods

From a prospective LRYGB database, postoperative endoscopies from February 2002 to June 2005 that found foreign material in the gastric pouch were reviewed. Presenting symptoms, time until endoscopy, and patient outcomes were evaluated. A therapeutic endoscopy was performed by using endo-shears and biopsy forceps to remove the foreign material.

Results

A total of 23 patients underwent 29 therapeutic endoscopies. From February 2002 to November 2004, 208 LRYGB were performed using silk suture for the outer layer of the gastrojejunostomy, and 21 patients (10%) had silk suture found on endoscopy. Peri-Strips were used from February 2002 to December 2003 (n = 153) and 6 patients (4%) had erosions. Since converting to Vicryl suture and Seamguard®, we have had 173 and 228 patients, respectively, without pouch erosion. The most common presenting symptom was abdominal pain (n = 15, 65%). Other symptoms included nausea (n = 13, 57%), vomiting (n = 12, 52%), dysphagia (n = 5, 22%), and melena (n = 3, 13%). Foreign material was found by a mean of 34 weeks. Of 29 therapeutic endoscopies, 20 resulted in resolution of symptoms (69%), 4 led to improvements (14%), and 5 had no effect (17%). There were no endoscopic complications and no anastomotic leaks.

Conclusions

Nonabsorbable material used during a LRYGB can migrate into the gastric pouch and cause UGI complaints. A therapeutic endoscopy will resolve most UGI symptoms. Using absorbable material in the creation of the gastric pouch and the gastrojejunostomy will avoid foreign material erosion.     

Simple preoperative parameters to assess technical difficulty during a radical perineal prostatectomy

Purpose

We aimed to propose a practical selection method predicting the easier radical perineal prostatectomy (RPP) cases before the operation.

Methods

Fifty sequential RPP cases were divided into two groups according to the estimated difficulty of the operation (Group I: Easier, Group II: Difficult) which was assessed by using a RPP difficulty scale, constituted by three parameters (operation time, blood loss, and the judgment of the surgeon) each ranging between 1 and 3 points. As the localization parameters, skin-to-prostatic apex (SPAD) and skin-to-prostatic base (SPBD) distances and distance between bilateral ischial tuberosities (ITD) were measured. During suprapubic ultrasonography, a probe-divergence angle (PDA) and prostate volumes (PV) were recorded. These parameters were compared between the groups.

Results

In Group I (n = 29) and Group II (n = 21), the difficulty scores were 4.37 (3–5) and 6.80 (6–9), respectively. Data of age, clinical stages, and findings of digital rectal examination were not different between groups. While SPBD, SPAD, and ITD values were found similar (p > 0.05), PDA and PV were significantly different. PDA was > 45 degree in 21 cases in Group I (72.4 %) and in 7 cases in Group II (33.3 %) (p = 0.011). The mean of PV was 37.4 (20–60) cc and 49.9 (30–75) cc in Group I and Group II, respectively (p = 0.001).

Conclusions

While planning RPP operations, by selecting the prostate cancer cases with a prostate of low volume and localized deeper in the pelvis during suprapubic ultrasonography, urologists may have a chance to perform this technique more easily during the learning period.     

A Prospective,Randomized, Phase III Study to Evaluate the Efficacy and Safety of Fibrin Sealant Grifols as an Adjunct to Hemostasis as Compared to Cellulose Sheets in Hepatic Surgery Resections

Background

Local hemostatic agents have a role in limiting bleeding complications associated with liver resection.

Methods

In this randomized, phase III study, we compared the efficacy and safety of Fibrin Sealant Grifols (FS Grifols) with oxidized cellulose sheets (Surgicel®) as adjuncts to hemostasis during hepatic resections. The primary efficacy endpoint was the proportion of patients achieving hemostasis at target bleeding sites (TBS) within 4 min (T₄) of treatment application. Secondary efficacy variables were time to hemostasis (TTH) at a later time point if re-bleeding occurs and cumulative proportion of patients achieving hemostasis by time points T₂, T₃, T₅, T₇, and T₁₀.

Results

The rate of hemostasis by T₄ was 92.8% in the FS Grifols group (n?=?163) and 80.5% in the Surgicel® group (n?=?162) (p?=?0.01). The mean TTH was significantly shorter (p?<?0.001) in the FS Grifols group (2.8?±?0.14 vs. 3.8?±?0.24 min). The rate of hemostasis by T₂, T₅, and T₇ was higher and statistically superior in the FS Grifols group compared to Surgicel®. No substantial differences in adverse events (AE) were noted between treatment groups. The most common AEs were procedural pain (36.2 vs. 37.7%), nausea (20.9 vs. 23.5%), and hypotension (14.1 vs 6.2%).

Conclusions

FS Grifols was safe and well tolerated as a local hemostatic agent during liver resection surgeries. Overall, data demonstrate that the hemostatic efficacy of FS Grifols is superior to Surgicel® and support the use of FS Grifols as an effective local hemostatic agent in these surgical procedures.

     

Endoscopic submucosal dissection and preoperative assessment with endoscopic ultrasonography for the treatment of rectal carcinoid tumors

Background

Rectal carcinoid tumors 10 mm in diameter or smaller located within the submucosal layer can be cured by local excision including endoscopic treatment. But complete resection of these tumors with endoscopic polypectomy is difficult. This study aimed to evaluate the usefulness of endoscopic submucosal dissection (ESD) and endoscopic ultrasonography (EUS) for the treatment of rectal carcinoid tumors.

Methods

In this study, 22 rectal carcinoid tumors in 21 patients were evaluated with EUS and treated using ESD from January 2004 to December 2008.

Results

The mean size of the resected tumors was 6.1 mm (range, 2.0–10 mm) on histopathologic evaluations. When the sizes of the tumors shown by EUS and histopathologic evaluation were compared, the mean values were not significantly different. All the tumors were located within the submucosal layer, and the accuracy of the preoperative depth determination with EUS was 100% (22/22). The mean duration of the ESD procedure was 37 min (range, 20–71 min). The overall rate of en bloc resection with ESD was 100% (22/22). Although postoperative bleeding occurred in two cases (9%), both cases were successfully managed by endoscopic hemostasis. No perforation or recurrence was observed during the mean follow-up period of 30 months (range, 7–66 months).

Conclusions

Endoscopic submucosal dissection and preoperative assessment with EUS are effective for treating rectal carcinoid tumors and enabling en bloc resection.     

Incidence and effect of calcifications after open-augmented Achilles tendon repair

Background and aims

The objective of this study was to analyse the incidence and effect on clinical outcome of post-operative Achilles tendon calcifications after open-augmented repair according to the Silfverskjöld technique.

Patients/methods

This retrospective study presents the results of follow-up examinations on 104 patients with Achilles tendon rupture who were treated according to the Silfverskjöld technique. Post-operative calcifications were identified by means of sonography, and clinical outcome was evaluated using the 100 points Thermann score. The average follow-up examination period was 3.7 years with an average patient age of 42.9 years. Two groups were identified and included those with (Group I) and those without (Group II) calcifications. Clinical outcome was evaluated using the Thermann score for both groups and was compared statistically by means of the two random sample t-test.

Results

Fifteen patients (Group I) developed tendon calcifications (14.4%) and 89 none (Group II). Group I scored 88.0 points and Group II 88.1 (good to very good outcome). There were no negative effects on clinical outcome (t = 0.98).

Conclusions

The incidence of tendon calcification after open-augmented repair of Achilles tendon rupture was 14.4% with no negative effects on clinical outcome as measured by the Thermann score.     

Endoscopic resection of granular cell tumors in the gastrointestinal tract: a single center experience

Background

The frequency of granular cell tumors (GCTs) identified in the gastrointestinal tract has recently increased with the increased use of routine endoscopy. Endoscopic treatment is increasingly used as an alternative to traditional surgical resection, but there are few reports on the efficacy, safety, and long-term prognosis of endoscopic treatment for GCTs. The aim of this study was to assess the efficacy, safety, and long-term prognosis of endoscopic resection for the gastrointestinal GCTs.

Methods

We examined a total of 27 GCTs in 25 patients who were treated by endoscopic resection from January 2007 to February 2011. For endoscopic resection, endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) was used.

Results

Twenty GCTs were located in the esophagus, 5 in the stomach, and 2 in the colon. The median size of the GCTs was 10 mm; the largest size, located in the ascending colon, measured 18 mm. EMR with a ligation device was performed in 20 cases, conventional EMR in 5 cases, and ESD in 2 cases. En bloc resection was performed in 25 cases (92.6 %), and endoscopic complete resection piecemeal resection was achieved in 25 cases (92.6 %). Pathologic complete resection was achieved in 22 lesions (81.5 %). Intraprocedural bleeding was noted in three patients, with no occurrence of perforation or postprocedure stricture. No recurrence was observed during the mean follow-up period of 15 months (range 9–31 months).

Conclusions

Endoscopic resection appears to be a safe and effective treatment for GCTs in the gastrointestinal tract.