Combination therapy of ecabet sodium and cimetidine compared with cimetidine alone for gastric ulcer: prospective randomized multicenter study

BACKGROUND AND AIM: Little is known about the clinical efficacy of co-therapy of ecabet sodium, a mucoprotective agent, and a histamine H2-receptor antagonist. The aim of the present study was to assess its additive benefit in combination with cimetidine for gastric ulcer. METHODS: In this prospective randomized study, after gastric ulcer was confirmed by endoscopy, 200 patients in 47 hospitals received either ecabet sodium 1 g b.i.d and cimetidine 400 mg b.i.d. (EC), or cimetidine 400 mg b.i.d. alone (C) for 8 weeks. Healing was examined by endoscopy at 4 and 8 weeks. RESULTS: Of the intention-to-treat (ITT) population (EC, 103; C, 97), 181 patients comprised the per protocol (PP) analysis (EC, 93; C, 88). At 4 weeks, healing rates were significantly higher in the EC group (60%) than in the C group (36%) ( p < 0.01). At 8 weeks, those by the ITT and PP analyses were 82% (EC) versus 58% (C), and 90% (EC) versus 64% (C), respectively ( p < 0.01 and p < 0.001). Symptom relief rates (EC vs C) at 2, 4 and 8 weeks were 73%versus 47% ( p < 0.01), 89%versus 66% ( p < 0.001), and 97%versus 73% ( p < 0.001), respectively. Significant additive effects of ecabet sodium were observed in patients aged 60 years or older, with solitary and medium to large ulcer, and without smoking or drinking habits. No adverse effects were critical. CONCLUSION: Ecabet sodium significantly augmented gastric ulcer healing and symptom relief by cimetidine, especially in the elderly.     

Prospective single-arm trial of two-week rabeprazole treatment for ulcer healing after gastric endoscopic submucosal dissection

Aim: Endoscopic submucosal dissection (ESD) causes artificial ulcers, and there is no consensus regarding the degree of healing in ESD‐induced ulcers or the optimal duration of proton pump inhibitor (PPI) treatment. The aim of the present study was to investigate the healing rates of post‐ESD ulcers in response to the protective effect of 2‐week PPI treatment. Methods: Between February 2007 and March 2010, 75 patients/75 lesions and 55 patients/55 lesions were enrolled as interim and per‐protocol groups, respectively. All patients were prescribed rabeprazole (10 mg/day) orally for 16 days beginning on the day before ESD. Follow‐up endoscopy was carried out 8 weeks after ESD to evaluate ulcer healing. The primary end‐point was the healing rate of post‐ESD ulcers at 8 weeks after ESD. Secondary end‐points were the rate of post‐ESD bleeding with emergency endoscopy and the rate of other severe adverse effects during the study period. Results: The transitional rate to scarring‐stage ulcers was 80.0% (44/55). Location in the lesser curve and large resected size (>40 mm) were statistically significant predictors for delayed ulcer healing by univariate analysis and the latter was still significant by the multivariate analysis. Post‐ESD bleeding occurred within 2 weeks in two cases (2.7%), but both cases were successfully managed with endoscopic hemostasis only. Severe adverse effects did not occur. Conclusions: Two‐week administration of PPI for post‐ESD gastric ulcers may be sufficient to aid healing without increasing any adverse effects in cases where there are no possible deteriorating factors on ulcer healing, although large resection and/or resection in the lesser curve may result in delayed healing even after 8 weeks of ESD.     

Bleeding after endoscopic submucosal dissection of gastric lesions

Endoscopic submucosal dissection (ESD) is generally used to treat gastric mucosal and submucosal lesions. Nevertheless, ESD is more difficult and complicated to perform than a traditional endoscopic mucosal resection, which can increase the incidence of various complications including hemorrhage, perforation and infection. Hemorrhage is a major post‐ESD complication. Prevention and early diagnosis of post‐ESD bleeding for gastric lesions are closely associated with the efficacy and safety of the operation. Many studies have reported the risks of and the preventative measures for hemorrhage after gastric ESD, but there remain some issues to be solved. We thus reviewed the risk factors, precautions and treatments for hemorrhage after ESD of gastric lesions.     

Implantation of esophageal cancer onto post-dissection ulcer after gastric endoscopic submucosal dissection

A case in which implantation of esophageal squamous cell carcinoma onto a post-dissection gastric ulcer was strongly suspected is presented. A 72-yearold man with alcoholic liver cirrhosis underwent esophagogastroduodenoscopy(EGD). Esophageal cancer(EC)(Mt, 20 mm, 0-Is) and gastric cancer(GC)(antrum, 15 mm, 0-Ⅱc) were identified. Biopsy specimens revealed moderately differentiated squamous cell carcinoma(SCC) and differentiated adenocarcinoma, respectively. The GC was resected by endoscopic submucosal dissection(ESD) [14 mm × 9 mm, type 0-Ⅱc, tub1, p T1a(M), ly0, v0, HM(-), VM(-)]. Two months after ESD, radiation therapy was started for the EC, and an almost complete response was obtained. Nine months after the ESD, a follow-up EGD showed a submucosal tumor-like lesion with ulceration, located immediately under the post-ESD scar, and biopsy specimens showed moderately differentiated SCC. There were no similar lesions suggesting hematogenous or lymphatic metastasis in the stomach.     

Short-term healing process of artificial ulcers after gastric endoscopic submucosal dissection

Background/Aims

The relationship between the appearance of an ulcer and postoperative bleeding after gastric endoscopic submucosal dissection (ESD) is not well understood. To explore this potential relationship, we retrospectively analyzed the short-term healing process of ESD.

Methods

A total of 520 consecutive lesions in 434 patients seen between January 2004 and December 2009 were retrospectively investigated. At the second-look endoscopy, which occurred between 1 and 8 days after ESD, artificial ulcers were categorized into 6 patterns according to Forrest''s classification: spurting bleeding, oozing bleeding, non-bleeding visible vessel, adherent clot, black base/spot, and clean base. From these data, a short-term healing model of the artificial ulcer was generated.

Results

Ulcer base changed gradually from a bloody to a clean one. The bleeding or non-bleeding visible vessel categories, which occurred in approximately one quarter of the ulcers within 3 days of ESD, were rarely observed 4 days after ESD.

Conclusions

Ulcers that occur after gastric ESD heal in line with a specific time course, and it appears that most healing occurs without massive bleeding.     

Lymph node metastasis after endoscopic submucosal dissection of a differentiated gastric cancer confined to the mucosa with an ulcer smaller than 30 mm

In the expanded indications for endoscopic resection, Japanese guidelines for gastric cancer include differentiated cancers confined to the mucosa with an ulcer <30 mm. We describe a patient with lymph node metastasis after curative endoscopic submucosal dissection (ESD) for a tumor of this indication. The patient was a 70‐year‐old man with chronic hepatitis C. He underwent ESD for early gastric cancer in May 2010. Pathology revealed a moderately differentiated adenocarcinoma, 22 × 17 mm in size, that was confined to the mucosa with an ulcer. The horizontal and vertical margins were negative for the tumor. We diagnosed thiscase as curative resection of expanded indication and followed this patient with endoscopy, abdominal ultrasonography (AUS) or enhanced computed tomography (CT) approximately every 6 months. After 17 months, lymph node metastasis was detected with AUS and CT and diagnosed by endoscopic ultrasound‐guided fine‐needle aspiration biopsy in August 2011. Distal gastrectomy with D2 dissection was carried out in December 2011. Although it is low, the possibility of recurrence should be borne in mind after endoscopic treatment of early gastric cancer, despite its inclusion in the expanded indications for endoscopic resection.     

Benefits of endoscopic submucosal dissection according to size and location of gastric neoplasm, compared with conventional mucosal resection

Background and Aims:  To clarify optimal therapeutic strategies for early gastric cancers without vestigial remnant or recurrence, we evaluated the benefits of endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) according to tumor size and location.
Methods:  From January 2000 to December 2007, a total of 328 gastric lesions were treated using conventional EMR, while 572 lesions were treated by ESD. Patients who underwent surgery on the upper gastrointestinal tract before EMR or ESD were excluded from the study. We compared tumor size, location and rates of complete resection, curative resection, postoperative bleeding, perforation and local recurrence between EMR and ESD according to tumor situation.
Results:  Overall local complete resection rate (EMR, 64.2%; ESD, 95.1%) and overall curative resection rate (EMR, 59.5%; ESD, 82.7%) were significantly higher in ESD than in EMR. No significant differences were seen in complication rates between EMR and ESD. Local recurrence was detected in 13 lesions (4.0%) of the EMR group during follow up. In contrast, no local recurrence was detected in the ESD group. For lesions 5 mm or less in diameter, complete resection rate in the EMR group was not significantly inferior to that in the ESD group at any location. However, rates were overwhelmingly better in the ESD group than in the EMR group for lesions more than 5 mm in diameter, regardless of location.
Conclusion:  We concluded that lesions exceeding 5 mm in diameter should be treated by ESD, although a high resection rate is obtained also with EMR for lesions of 5 mm or less in diameter.     

Localized gastric amyloidosis successfully treated with endoscopic submucosal dissection: A case report

Rationale:Amyloidosis is a general term that refers to the extracellular deposition of amyloid. The amyloid can also be deposited in a single organ. However, cases of localized gastric amyloidosis have rarely been reported. Here, we report a case of localized gastric amyloidosis that was successfully treated with endoscopic submucosal dissection.Patient concern:A 60-years-old man underwent esophagogastroduodenoscopy as part of a regular check-up without any comorbidities or symptoms.Diagnostics:A 12 mm-sized, round, elevated lesion with a central depression, which was covered with normal mucosa, and located on the greater curvature of the lower body of the stomach was discovered during endoscopy. Subsequently, endoscopic ultrasonography was performed, which revealed a 11.7 mm-sized, hypoechoic, heterogeneous lesion located in the muscularis mucosa and submucosa. A biopsy was performed, and amyloid deposition was confirmed. Although other investigations for checking systemic amyloidosis were performed, there were no specific findings. Therefore, the final diagnosis was localized gastric amyloidosis.Interventions:Endoscopic submucosal dissection was performed according to the patient''s request and the lesion was completely removed.Outcomes:The patient was followed-up for 3 years without any recurrence.Conclusions:Endoscopic submucosal dissection can be good diagnostic and treatment option for localized gastric amyloidosis.     

Helicobacter pylori status and the extent of gastric atrophy do not affect ulcer healing after endoscopic submucosal dissection

BACKGROUND: Eradication therapy for Helicobacter pylori is effective in preventing peptic ulcer recurrence, but its efficacy in ulcer healing is still controversial. The effect of H. pylori on artificial ulcers after endoscopic resection is not known. The purpose of the present study was therefore to evaluate the influence of H. pylori infection on ulcer healing after endoscopic submucosal dissection (ESD). METHODS: One hundred and 10 patients who underwent ESD for gastric tumors, and for whom the infection status of H. pylori was confirmed before treatment, were included. The healing stage was studied by endoscopy performed at 8 weeks after ESD. In addition, 73 patients whose serum pepsinogen (PG) was evaluated before ESD, were divided into three groups: PG positive (PGI相似文献   

Risk factors for delayed bleeding from endoscopic submucosal dissection of gastric neoplasms

Abstract

Objective. Delayed bleeding is a major complication of endoscopic submucosal dissection (ESD) of gastric neoplasms. We aimed to clarify risk factors for delayed bleeding from ESD. Material and methods. This study included 447 patients in whom 544 gastric neoplasms were resected by ESD between April 2006 and March 2011 in Yamaguchi University Hospital. We analyzed risk factors for delayed bleeding from ESD in relation to various clinical and pathological factors. Results. En bloc resection rate was 95.4% (519/544), and curative resection rate was 87.8% (477/544). Delayed bleeding occurred in 7.0% (38/544) and perforation occurred in 1.8% (10/544) of patients. Univariate analysis revealed platelet count (Plt) <15 × 10⁴/μl (p = 0.013), prothrombin time (PT) <70% (p = 0.044), resected size ≥50 mm (p = 0.038), and positive/indeterminate lateral margin (p = 0.012) to be risk factors for delayed bleeding. Multivariate analysis showed that Plt <15 × 10⁴/μl (odds ratio [OR], 2.62; 95% confidence interval [CI]: 1.17–5.53, p = 0.020) and positive/indeterminate lateral margin (OR, 5.45; 95% CI: 1.39–17.95, p = 0.018) were independent risk factors for delayed bleeding. Conclusions. Low Plt, low PT, large resected size, and positive/indeterminate lateral margin were significant risk factors for delayed bleeding from ESD. Patients with these risk factors must be carefully observed for signs of delayed bleeding.     

Comparison of endoscopic submucosal dissection and surgical resection for treating gastric subepithelial tumours

Objective For subepithelial tumours (SETs) of the stomach, surgical resection is the gold standard treatment. With the recent advent of endoscopic resection techniques and devices, endoscopic submucosal dissection (ESD) has been considered as an alternative treatment for SETs. The aim of our study was to evaluate the clinical outcomes of ESD for treating gastric SETs compared with surgical resection. Methods Between January 2006 and September 2014, 55 patients with gastric SETs (13 gastrointestinal stromal tumours (GISTs), 27 leiomyomas, and 15 others) were treated by ESD and 27 patients (19 GISTs, two leiomyomas, and six others) underwent surgical resection. We retrospectively reviewed the therapeutic outcomes, procedure-related complications, post-procedure hospital stays, and medical costs of the two groups. Results The complete resection rate of the ESD group was lower than that of the surgery group (81.8% vs. 100%, p?=?0.026). Although the incidence of complications that occurred with ESD was higher than that associated with surgical resection, there were no significant between-group differences (12.5% vs. 3.7%, p?=?0.261), and all complicated cases were successfully treated without mortality. The ESD group had significantly shorter post-procedural hospital stays (median five days vs. eight days, p?=?0.034) and lower medical costs (median $2374 vs. $4954, p <0.001) than the surgery group. There were no recurrences in either group during the follow-up period. Conclusions ESD is an efficient treatment tool for gastric SETs in selected patients. Additionally, ESD has the advantages of shorter hospital stays and lower medical costs compared with surgery.     

Randomized controlled trial comparing submucosal endoscopy with mucosal resection and endoscopic submucosal dissection in the esophagus and stomach: Animal study

Background and Aim

In Western countries, endoscopic submucosal dissection (ESD) has not prevailed as a result of training problems and a target patient population. We have previously reported a hybrid ESD technique, submucosal endoscopy with mucosal resection (SEMR), in which the submucosal dissection is carried out chiefly by blunt balloon dissection. We have also reported successful application in the porcine colon. In the present study, we compared the safety and efficacy of SEMR with ESD in the porcine esophagus and stomach.

Methods

SEMR and ESD were carried out in eight domestic pigs under general anesthesia. Resection sites were marked by circumferential coagulation. After circumferential ESD knife mucosal incision, submucosal fluid cushion (SFC) was created. In the SEMR group, the balloon catheter was inserted deep into the SFC. The balloon was then inflated and pulled back toward the endoscope tip repeatedly, altering the direction, to disrupt the submucosa. Residual strands were cut with an IT‐knife. En bloc resection rates, procedure times, complications and dissection difficulty scales (DDS) were recorded prospectively. DDS were rated using a visual analog scale.

Results

Thirty‐two resections (8 SEMR/8 ESD in the esophagus; 8 SEMR/8 ESD in the stomach) were done with no major adverse events. There was no statistical difference between the two techniques in either location in the above categories measured.

Conclusions

SEMR and traditional ESD are comparable techniques in safety and effectiveness when carried out in the esophagus and stomach. SEMR may serve as a more appealing technical option for endoscopists who are unable to sustain a traditional ESD practice volume.     

Endoscopic predictive factors associated with local recurrence after gastric endoscopic submucosal dissection

Objective: Endoscopic submucosal dissection (ESD) has been accepted as the treatment of choice for gastric epithelial neoplasia. Endoscopic characteristics of the primary lesion and post-ESD scars may be informative to predict the possibility of local recurrence.

Methods: Between November 2008 and July 2015, a retrospective study was conducted in a single-tertiary referral hospital. Consecutive patients who underwent ESD for early gastric cancer (EGC) or high-grade dysplasia were analyzed to evaluate the incidence of local recurrence and associated endoscopic characteristics.

Results: A total of 639 lesions were analyzed. The rates of en-bloc and complete resection were 98.1% and 95.5%, respectively. A total of 15 local recurrent lesions were found (2.3%). The endoscopic findings of primary lesions associated with local recurrence were a lesion size ≥20?mm (odds ratio, OR, 4.408; 95% confidence interval, CI, 1.369–14.186, p?=?.013) and incomplete endoscopic resection (OR 17.059, 95% CI 4.887–59.551, p?Conclusion: Lesions with larger size (≥ 20?mm) and incompletely resected lesions had higher risk of local recurrence. Endoscopic forceps biopsy is unnecessary for even-flat ESD scar without erythematous changes.