Comparison of 20-gauge Procore® and 22-gauge Acquire® needles for EUS-FNB of solid pancreatic masses: an observational study

Background and Aims: Endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) has been proposed to obtain high-quality tissue samples for pancreatic tumors. We performed an observational study to compare EUS-FNB with a 20-gauge Procore® needle versus a 22-gauge Acquire® needle. Our primary endpoint was the quantity of the obtained tissue, as defined by the mean cumulative length of tissue core biopsies per needle pass.

Methods: Sixty-eight EUS-FNB were consecutively performed on patients with a pancreatic mass. The choice of needle depended on availability at the time of admission: 34 punctures were performed with each needle. Histological material was studied in a blinded manner with respect to the needle, and the cumulative length of tissue core biopsies per needle pass was determined. Intraobserver and interobserver variability of this criterion was then evaluated.

Results: There were no between-group differences. Histological diagnosis was achieved and core biopsy specimens were obtained in 28 out of 34 patients (82%) in the 20-gauge Procore® group and in 33 out of 34 patients (97%) in the 22-gauge Acquire® group (p?=?.1). The mean cumulative length of tissue core biopsies per needle pass was significantly higher with the 22-gauge Acquire® needle with 8.2?±?4.2?mm versus 4.2?±?3.8?mm for the 20-gauge Procore® needle (p?<?.01). No intra and inter-observer variability of this criterion was observed.

Conclusions: Our results suggest significant differences, with a mean cumulative length of tissue core biopsies per needle pass significantly higher with the 22-gauge Acquire® needle. This simple criterion seems reliable and reproducible.     

22G versus 25G biopsy needles for EUS-guided tissue sampling of solid pancreatic masses: a randomized controlled study

Background/Objectives: No comparative study of 22-gauge biopsy needles (PC22) and 25-gauge biopsy needles (PC25) has been conducted. We prospectively compared the diagnostic accuracy of PC22 and PC25 in patients with pancreatic and peripancreatic solid masses.

Methods: We conducted a randomized noninferiority clinical study from January 2013 to May 2014 at Samsung Medical Center. A cytological and histological specimen of each pass was analyzed separately by an experienced pathologist. The primary outcome was to assess the diagnostic accuracy using the PC22 or PC25. Secondary outcomes included the optimal number of passes for adequate diagnosis, core specimen yield, sample adequacy, and complication rates.

Results: Diagnostic accuracy of combining cytology with histology in three cumulative passes was 97.1% (100/103) for the PC22 and 91.3% (94/103) for the PC25 group. Thus, noninferiority of PC25 to PC22 was not shown with a 10% noninferiority margin (difference, ?5.8%; 95% CI, ?12.1 to ?0.5%). In a pairwise comparison with each needle type, two passes was non-inferior to three passes in the PC22 (96.1% vs. 97.1%; difference, ?0.97%; 95% CI ?6.63 to 4.69%) but noninferiority of two passes to three passes was not shown in the PC25 group (87.4% vs. 91.3%; difference, ?3.88%; 95% CI, ?13.5 to 5.7%).

Conclusions: Non-inferiority of PC25 to PC22 diagnostic accuracy was not observed for solid pancreatic or peripancreatic masses without on-site cytology. PC22 may be a more ideal device because only two PC22 needle passes was sufficient to establish an adequate diagnosis, whereas PC25 required three or more needle passes.     

Comparison of oral vs intravenous phytonadione (vitamin K1) in patients with excessive anticoagulation: a prospective randomized controlled study

BACKGROUND: Treatment of patients with excessive anticoagulation is routinely done by intravenous phytonadione (vitamin K1). Oral administration of phytonadione has been shown to be an effective alternative to the intravenous route, but these methods have never been compared directly. Our objective was to compare efficacy and safety of intravenous vs oral phytonadione treatment in patients with excessive anticoagulation without bleeding. METHODS: The study was a prospective randomized controlled trial of consecutive patients presenting with excessive anticoagulation without major bleeding. Patients with a baseline international normalized ratio (INR) of 6 to 10 (n = 44, 47 episodes) received either intravenous or oral phytonadione (0.5 mg or 2.5 mg, respectively), and patients with an INR greater than 10 (n = 17, 19 episodes) received 1 mg or 5 mg, respectively. Efficacy and safety end points were sequential INR changes and the proportion of patients achieving therapeutic range (INR, 2-4), overcorrection (INR<2.0), or undercorrection (INR>4.0) INR values. RESULTS: Sixty-six episodes of excessive anticoagulation were studied. In patients with baseline INR 6-10 the response to intravenous phytonadione was more rapid than in the oral group, and the proportion of patients reaching therapeutic range INR at 6 hours (11/24 vs 0/23) and at 12 hours (16/24 vs 8/23) was significantly higher. However, mean +/- SD INR values were similar for both groups at 24 hours (2.9 +/- 0.8 vs 2.6 +/- 0.8). Patients in the intravenous group tended to be more often (7/24 vs 2/23) overcorrected (INR<2). In patients with baseline INR values greater than 10 efficacy and safety were comparable for both routes of administration. CONCLUSION: Oral administration of phytonadione had similar efficacy and safety as intravenously administered phytonadione and may be suitable for treatment of patients with excessive anticoagulation.     

Traumatic vs. atraumatic 22 G needle for therapeutic and diagnostic lumbar puncture in the hematologic patient: a prospective clinical trial

We investigated the impact of needle type on post lumbar puncture headache (PLPH) in hematologic patients undergoing LP. We prospectively compared traumatic (TN) vs. atraumatic 22G needles. Twenty-seven patients underwent 48 LPs, 22 with chemotherapy injection. PLPH occurred almost exclusively with TN (4% vs. 30% p=0.02), irrespective of chemotherapy injection.     

Natural history of pancreatic cystic lesions: A multicenter prospective observational study for evaluating the risk of pancreatic cancer

Background and Aim

The aim of this study is to elucidate the natural history of pancreatic cystic lesions (PCLs), including branch duct‐type intraductal papillary mucinous neoplasm (BD‐IPMN), via midterm follow‐up analysis of a multicenter prospective observational study (NSPINAL study).

Methods

From July 2011 to October 2016, 881 patients with PCLs were enrolled in NSPINAL study, and 664 patients with > 12 months of follow up were analyzed. Every patient was asymptomatic, and endoscopic ultrasound was performed at the initial diagnosis to exclude high‐risk individuals. Follow up included endoscopic ultrasound, computed tomography, or magnetic resonance imaging at least once a year. Serial morphological changes and the pancreatic cancer (PC) incidence, including malignant progression of PCLs, were evaluated.

Results

The 664 patients (358 men) were followed for a median of 33.5 months (interquartile range 29). The cyst and main pancreatic duct sizes were 16.6 ± 9.3 and 2.3 ± 1.0 mm, respectively. Morphologically, 518 cases were multilocular, 137 were unilocular, and 9 had a honeycomb pattern; 269 cases involved multifocal lesions. Ninety‐six patients (14.5%) showed worsening progression on imaging. There were two resectable and four unresectable cases of pancreatic ductal adenocarcinoma and three cases of malignant BD‐IPMN. The 3‐year risk of developing PC was 1.2%. The standardized incidence ratio for PC among PCLs was 10.0 (95% confidence interval 3.5–16.5), and the standardized incidence ratio among BD‐IPMN was 16.6 (95% confidence interval 5.1–28.1). Multivariate analysis showed that development of symptoms and worsening progression were significant predictors of PC.

Conclusions

Malignant progression of PCLs, including PC development, is not uncommon. Patients with PCLs should be carefully monitored to detect pancreatic ductal adenocarcinoma at early stages.     

Percutaneous stenting and chemotherapy for unresectable pancreatic cancer: Comparison of irradiation stents vs conventional metal stents

ObjectivesPercutaneous stenting is a palliative method to relieve obstructive jaundice caused by unresectable pancreatic carcinoma. In this study, we aimed to compare the safety and efficacy of irradiation stents and conventional metal stents.MethodsA total of 32 patients who received irradiation stents or conventional metal stents to treat obstructive jaundice caused by locally advanced pancreatic cancer were included in this retrospective study. Chemotherapy using gemcitabine was performed after jaundice subsided. Stent patency, technical success, survival, and complications were compared between groups.ResultsSeventeen patients were enrolled in the irradiation stent group (ISG), and 15 patients were enrolled in the uncovered stent group (USG). Median and mean stent patency time were 9.8 months (95% CI, 7.682–11.981) and 9.506 months (95% CI, 8.0–11.012) in the ISG, respectively, vs 8.8 months (95% CI, 6.528–11.072) and 7.62 months (95% CI, 5.917–9.323) in the USG, respectively (P = 0.019). Median and mean overall survival were 10.4 months (95% CI, 8.383–12.417) and 9.953 months (95% CI, 8.408–11.498), respectively, in the ISG vs 9.7 months (95% CI, 7.901–11.499) and 8.14 months (95% CI, 6.44–9.84), respectively, in the USG (P = 0.027).ConclusionsIrradiation stents extend stent patency and overall survival compared with conventional biliary stents for the treatment of pancreatic carcinoma complicated by obstructive jaundice. Irradiation stents combined with chemotherapy may be a better choice for the treatment of obstructive jaundice caused by unresectable pancreatic carcinoma.     

The effectiveness of enteral nutrition for patients with primary liver cancer: A randomized controlled study protocol

Objective:The objective of this study is to explore the influence of the enteral nutrition on primary liver cancer patients after receiving hepatectomy.Method:This is a prospective randomized controlled research, which will be conducted between April 2021 and April 2022. Approval is obtained from the Research Ethics Committee of Chun’ an County First People''s Hospital (A20201108). Patients who meet the following conditions will be included in this experiment:

• (1)the patients aged 18 to 70 years;
• (2)in line with clinical diagnostic criteria for primary liver cancer;
• (3)planned liver resection for primary liver cancer;
• (4)liver function status of Child-Pugh A.

Patients with the following characteristics are excluded:

• (1)a history of other malignancy;
• (2)mental disorder;
• (3)severe diabetes or poor glycemic control;
• (4)serious complications: bleeding and bile leakage;
• (5)poor medical condition: renal failure, respiratory or heart failure.

Our investigation includes sixty patients who meet our inclusion criteria. The primary endpoints are length of postoperative hospital stay and liver function index. The secondary results involve the first flatus time and the first defecation time.Results:Table 1 indicates the postoperative outcomes between treatment group and control group.Conclusion:Enteral nutrition can improve recovery in the primary liver cancer patients after receiving hepatectomy.Trial registration:The protocol has been registered in Research Registry (researchregistry6275)     

The prognostic role of fatigue,depression and anxiety on postoperative outcomes after pancreatectomy for pancreatic cancer. A prospective observational study (FAT-PRO study)

ObjectivesThis study aims to assess the prevalence of preoperative fatigue, depression and anxiety among patients undergoing pancreatic surgery for pancreatic cancer (PC), and possible relationship with postoperative outcomes.MethodsProspective data from 162 consecutive patients undergoing pancreatectomy for PC at a third-level referral centers for pancreatic surgery were collected. All patients preoperatively completed four questionnaires assessing depression (PHQ-9), anxiety (STAI-Y2), chronic illness fatigue (FACIT-F) and cancer therapy fatigue (FACT-G).ResultsForty patients (25%) where in the first quartile for chronic illness (FACIT-F ≤34) and/or cancer therapy (FACT-G ≤78) fatigue, 26 patients (16%) met the criteria for major depression (PHQ-9 ≥10) and 34 patients (21%) had anxiety symptoms (STAI-Y2 ≥40). Cancer therapy fatigue was significantly associated with higher rates of morbidity (70% vs 49%), major morbidity (Clavien-Dindo ≥3) (28% vs 11%), post-pancreatectomy hemorrhage (18% vs 4%), pulmonary complications (20% vs 9%) and mortality (8% vs null) (all P ≤ 0.01). Major depression was associated with higher rates of post-pancreatectomy hemorrhage and readmission (23% vs 5%). Multivariable logistic regression analysis of preoperative factors confirmed diabetes (OR 2.71, 95%CI 1.01–7.20; P = 0.04), ASA score ≥3 (OR 4.12, 95%CI 1.52–11.21; P < 0.01) and cancer therapy fatigue (OR 2.95, 95%CI 1.01–8.74; P = 0.04) to be independent predictors of major morbidity.ConclusionsHigher levels of fatigue (in particular cancer therapy fatigue) strongly correlates with worse postoperative outcomes.     

Comparison of the two time schedules for endoscopic sclerotherapy: a prospective randomised controlled study.

To compare the efficacy and safety of one week versus three weeks interval treatment schedules of endoscopic sclerotherapy, injections were carried out in a prospective manner in 96 patients with variceal bleeding; 47 on a one week and 49 on a three weeks treatment schedule. Weekly endoscopic sclerotherapy eradicated oesophageal varices significantly (p less than 0.01) earlier (mean +/- SD 7.1 +/- 2.43 weeks) as compared with the three weeks regimen (mean +/- SD 14.86 +/- 4.86 weeks). The rebleeding rate was also significantly less (p less than 0.05) with weekly endoscopic sclerotherapy (8.5%) as compared with three weeks endoscopic sclerotherapy treatment (26.5%). The amount of alcohol and the number of endoscopic sclerotherapy courses required for complete variceal eradication did not differ significantly between the two groups. Patients undergoing weekly injections were seen to have significantly more oesophageal ulcers (p less than 0.01) as compared with the three weeks group, necessitating at times (23%) postponement of the procedure. There was, however, no difference between the two groups in the frequency of oesophageal stricture formation, dysphagia, retrosternal pain, and fever. Mortality was also similar in the two groups. It can be concluded that a weekly schedule of endoscopic sclerotherapy appears superior to a three weeks schedule.     

Effect of esophageal variceal sclerotherapy (EVS) on lung function. A prospective controlled study

A prospective, controlled study to determine the short- and long-term effects of esophageal variceal sclerotherapy (EVS) on lung function was carried out on 11 patients with cirrhotic portal hypertension and variceal hemorrhage. Eleven patients with chronic liver disease undergoing diagnostic endoscopy served as controls. There was no difference in lung function tests and gas exchange in both the EVS or control groups after either procedure. No change in these parameters was noted during follow-up on continued sclerotherapy in the EVS group. Ventilation-perfusion scans and chest roentgenograms, performed before and after EVS, demonstrated no significant change. We conclude that in patients with stable liver disease and without hepatic failure, EVS does not result in serious short- and long-term impairment of lung function.     

Two dosages of remifentanil for patient-controlled analgesia vs. meperidine during colonoscopy: A prospective randomized controlled trial

Background and studyCombined use of opiates and benzodiazepines often results in delayed discharge after colonoscopy.AimsTo compare sedation quality of two dosages of patient controlled analgesia remifentanil with one another and with that of a midazolam-meperidine association during colonoscopy.MethodsNinety patients undergoing colonoscopy were randomly assigned to three groups. Group M received a meperidine bolus (0.7 mg/kg) and sham patient controlled analgesia. Group R1 received remifentanil 0.5 μg/kg and group R2 remifentanil 0.8 μg/kg together with a patient-controlled analgesia pump injecting further boluses (2-min lock-out). Technical difficulties of the examination, gastroenterologist's and patient's satisfaction with sedoanalgesia were evaluated after colonoscopy on a 100 mm Visual Analogue Scale. Patient's satisfaction was assessed 24 h later.ResultsGroup M had more adverse events (p = 0.044), required more rescue boluses (p = 0.0010), had lower Observer's Assessment of Alertness and Sedation Scale score at the end of the procedure (p = 0.0016) and longer discharge time (p = 0.0001). Groups R1 and R2 did not differ with respect to these variables. Patient's degree of pain and satisfaction with sedo-analgesia, endoscopist's technical difficulty and satisfaction were not different among groups.ConclusionsRemifentanil patient controlled analgesia is a safe approach to sedation for colonoscopy.     

A comparative evaluation of sclerosants for esophageal varices: a prospective randomized controlled study

The aim of this prospective randomized controlled study was to find a safe and effective sclerosing solution for endoscopic injection sclerotherapy in the treatment of esophageal variceal bleeding. Ninety consecutive patients with portal hypertension and variceal bleeding were randomized to receive sclerotherapy with 5% ethanolamine oleate, 3% sodium tetradecyl sulfate, or absolute alcohol at an interval of 3 weeks. Sixty-four patients who received more than three sessions were analyzed. All three agents were found to have similar success and complication rates (p greater than 0.05). However, absolute alcohol required fewer sessions (p less than 0.01) and lesser amounts (p less than 0.01) to produce successful variceal sclerosis and had the added advantage of low cost and easy availability.     

The impact of preoperative biliary stenting in pancreatic cancer: A case-matched study from the German nationwide pancreatic surgery registry (DGAV StuDoQ|Pancreas)

Background/ObjectiveThe impact of preoperative biliary stenting (PBS) before pancreatoduodenectomy (PD) for pancreatic ductal adenocarcinoma (PDAC) is controversial.MethodsPatients undergoing PD with or without PBS for PDAC were identified from the German DGAV-StuDoQlPancreas registry. The impact of PBS on perioperative complications was analyzed.Results1133 patients undergoing PD for PDAC were identified from the registry. After matching, 480 PBS patients vs. 480 patients without PBS were analyzed. Postoperative complications Clavien-Dindo classification (CDC) grade IIIa-IVb were higher in PBS patients (PBS 27% vs. no PBS 22%, p = 0.027). 320 PBS patients (66%) had no history of jaundice. In these patients, PBS was associated with higher morbidity. In contrast, PBS was not associated with higher complication rates in patients with history of jaundice. Serum bilirubin levels of 15 mg/dl and higher lead to more CDC IIIa-IVb (24% vs. 28%, p = 0.053) and higher mortality (3% vs. 7%, p < 0.001). PBS in patients with serum bilirubin levels of >15 mg/dl increased CDC IIa-IVb complications (21% vs. 50%, p = 0.001), mortality was equivalent.ConclusionMost PBS procedures were performed in patients with no history of jaundice and increased morbidity. Serum bilirubin levels >15 mg/dl lead to higher morbidity and mortality. PBS correlated with higher complication rates in these patients.     

Total cholesterol,alanine aminotransferase and the risk of primary liver cancer: A population-based prospective study

Previous studies have shown that serum total cholesterol (TC) and serum alanine aminotransferase (ALT) are associated with liver cancer risk. However, the common contribution of TC and normal-high ALT to primary liver cancer (PLC) has not been reported. We aim to assess the separate and joint effect of low TC level and normal-high ALT level on the risk of PLC, a large prospective cohort was conducted in our study.The participants were divided into 4 groups via the cross-matching method according to TC [low level (−)/non-low level (+)] and ALT [normal level (−)/normal-high level(+)] status, and using the lower quartile value of TC and the upper quartile value of ALT as a threshold, respectively. Incident PLC was confirmed by review of medical records. Cox proportional hazards regression models and interactive additive models were used to evaluate whether the joint effect of low TC level and normal-high ALT level is associated with the risk of PLC.During 1,248,895 person-years follow-up, 298 participants were diagnosed with PLC among 114,972 subjects. In male population, TC < 4.24 mmol/L was group “TC (−)”; TC ≥ 4.24 mmol/L was group “TC (+)”; ALT < 23 U/L was group “ALT (−)”: 33 U/L ≥ ALT ≥ 23 U/L was group “ALT (+)”. Compared with the group “TC (+)”, group “ALT (−)”, respectively, the adjusted hazard ratio (HR) and 95% confidence interval (95%CI) for PLC risk was 1.74 (1.36–2.25) in group “TC (−)” and 1.49 (1.15–1.94) in group “ALT (+)”. In combinatorial analysis, compared with group “TC (+) and ALT (−)”, the significant increased risk of PLC were observed in group “TC (+) and ALT (+)” (HR = 1.41; 95% confidence intervals [CI]: 1.02–1.95), group “TC (−) and ALT (−)” (HR = 1.67; 95%CI: 1.24–2.27) and group “TC (−) and ALT (+)” (HR = 2.72; 95%CI: 1.81–4.09), respectively. However, no statistical significance was found among female.The separate and joint effect of low TC level and normal-high ALT level was observed for PLC risk in males. When combined, individuals with coexistence of low TC level and normal-high ALT level significantly increase the risk of PLC.