Comprehensive Analysis of Adverse Events Associated with Gastric Peroral Endoscopic Myotomy: An International Multicenter Study.

BACKGROUND: Gastric peroral endoscopic myotomy (G-POEM) has emerged as an effective management approach for patients with refractory gastroparesis. This study aims to comprehensively study the safety of G-POEM and describe the predictive factors of adverse events (AEs) occurrence. METHODS: This study is a retrospective study involving 13 tertiary care centers (7 USA, 1 South America, 4 Europe, and 1 Asia). Patients who underwent G-POEM for refractory gastroparesis were included. Cases were identified by the occurrence of AEs. For each case, two controls were randomly selected and matched for age (± 10 years), gender, and etiology of gastroparesis. RESULTS: A total of 216 patients underwent G-POEM for gastroparesis. Overall, 31 (14%) AEs were encountered [mild 24 (77%), moderate 5 (16%), and severe 2 (6%)] during the duration of the study. The most common AE was abdominal pain (n = 16), followed by mucosotomy (n = 5) and capnoperitoneum (n = 4), and AEs were most commonly identified within the first 48-h post-procedure 18 (58%). The risk of adverse event occurrence was significantly higher for endoscopists with experience of < 20 G-POEM procedures (OR 3.03 [1.03-8.94], p < 0.05). CONCLUSION: G-POEM seems to be a safe intervention for refractory gastroparesis. AEs are most commonly mild and managed conservatively. Longitudinal mucosal incision, use of hook knife, use of clips for mucosal closure and endoscopist's experience with > 20 G-POEM procedures is significantly associated with decreased incidence of AEs.

Randomised clinical trial: the efficacy and safety of pancreatin enteric-coated minimicrospheres (Creon 40000 MMS) in patients with pancreatic exocrine insufficiency due to chronic pancreatitis--a double-blind, placebo-controlled study.

BACKGROUND: Pancreatic exocrine insufficiency (PEI) results in maldigestion, leading to abdominal pain, steatorrhoea, malnutrition and weight loss. AIM: To assess the efficacy and safety of pancreatin (Creon 40000 MMS) in treating PEI due to chronic pancreatitis (CP). METHODS: This was a 1-week, double-blind, randomised, placebo-controlled, parallel-group, multicentre study in India. Men and women ≥18 years of age with proven CP and PEI [defined as a coefficient of fat absorption (CFA) ≤80% during run-in phase] were randomised 1:1 to pancreatin or placebo (two capsules orally per main meal, one with snacks). The primary outcome measure was change in CFA from baseline to end of double-blind treatment (analysis of covariance). RESULTS: Of 62 patients randomised (34 pancreatin, 28 placebo), 61 completed treatment; one patient in the placebo arm withdrew consent before completion. Patient characteristics were similar in both groups except for the proportion of men (pancreatin 82% vs. placebo 68%). Patients receiving pancreatin had a statistically significant greater improvement in fat absorption from baseline to the end of double-blind treatment compared with those receiving placebo, with a least squares mean change (95% CI) in CFA of 18.5% (15.8-21.2) vs. 4.1% (1.0-7.2), respectively. This resulted in a treatment difference of 14.4% (10.3-18.5); P = 0.001. Patients receiving pancreatin also had a statistically significant greater improvement in nitrogen absorption and greater reductions in mean stool fat, stool frequency and stool weight compared with those receiving placebo. Treatment-emergent adverse events occurred in 12 patients on pancreatin and in seven on placebo; none led to study discontinuation. CONCLUSIONS: The results provide evidence for the efficacy of pancreatin (Creon 40000 MMS) in patients with pancreatic exocrine insufficiency due to chronic pancreatitis, and confirm that this formulation is well tolerated, with a good safety profile, at the dose administered.

Advances in therapeutic endoscopic treatment of common bile duct stones.

Advances in cannulation techniques and instruments have helped in difficult bile duct cannulation and thus stone extraction. For small common bile duct (CBD) stones, endoscopic papillary balloon dilatation has been proposed as an alternative to endoscopic papillotomy (EPT). The technique must undergo further evaluation before recommending its routine use. For most patients with bile duct stones, EPT remains the method of choice. Out of 8204 patients treated in three surgical endoscopy centers (Chile, Germany, and India), 86% to 91% of all CBD stones could be extracted subsequently after EPT using a Dormia basket; 4% to 7% required mechanical lithotripsy (ML) before removal and 3% to 10% of the patients needed other sophisticated techniques, such as electrohydraulic lithotripsy (EHL), laser-induced shock-wave lithotripsy (LISL), or extracorporeal shock-wave lithotripsy (ESWL). The local expertise and availability of equipment determines the choice of method used. In general, EHL or LISL is used for impacted CBD stones including stones in Mirizzi syndrome refractory to ML. ESWL is best suited for intrahepatic stones. Permanent stenting can be offered to poor risk patients instead of extensive procedures to clear the bile duct. Using currently available nonsurgical techniques, fewer than 1% of all patients with bile duct stones still require surgical intervention.

Endoscopic placement of indigenous plastic esophageal endoprostheses--does it still have a role in the era of expandable metallic stents? A prospective Indian study in 265 consecutive patients.

BACKGROUND AND STUDY AIMS: Esophageal endoprosthesis placement is an established method of palliating inoperable esophageal malignancy. However, the prosthesis choice varies, with expandable metal stents recently gaining popularity. We present our experience of using an indigenously developed plastic prosthesis in 265 patients prospectively in the period April 1992 to May 1996. PATIENTS AND METHODS: An indigenous endoprosthesis made of a medical grade, nontoxic, radiopaque plastic material was placed successfully in 259 patients after serial dilatation of the malignant stricture. Patients were followed up once every month for at least 6 months and also in between if they developed any significant symptoms. The results were analyzed prospectively with special emphasis on the cost of the therapy, technical success of placement, improvement of swallowing and occurrence of complications. RESULTS: The technical success of placement was 97.7% (259/265 patients). The mean dysphagia score improved from 3.2 to 1.2; 212 patients (81.8%) could swallow semisolids whereas 47 patients (18.2%) could swallow liquids. Though 75 patients (28.3%) had an associated tracheoesophageal fistula and 29.8% had received prior radiotherapy/chemotherapy, immediate complications like perforation, respiratory distress or severe hemorrhage were encountered in only 4.3% of patients. Late complications occurred in 12.7% and 32.8% of the patients complained of mild post-procedure pain in the chest. The overall procedure-related mortality was 3.9%. The average cost of the prosthesis was only US$ 15 per patient. CONCLUSIONS: Placement of a plastic prosthesis is still a very effective and safe method for relief of malignancy-induced dysphagia. The associated complications can be significantly reduced by modifying the prosthesis material/design and adhering to a careful technique. The extremely low cost of the prosthesis and its safety profile makes this treatment highly cost-effective and widely applicable in developing countries such as India.