Background Surgical repair of endoscopic perforations of the GI tract used to be the standard, but immediate, secure endoscopic closure has become an attractive alternative treatment with the ...potential to reduce morbidity and mortality. Objective We aimed to perform a systematic review of the medical literature on endoscopic closure of acute iatrogenic perforations of the GI tract. Design A systematic review was conducted according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines. Setting Available medical literature from 1966 through November 2013. Patients Patients with an acute perforation after an endoscopic procedure that was closed endoscopically. Interventions Endoscopic closure of an acute perforation of the GI tract. Main Outcome Measurements Clinically successful endoscopic closure. Results In our search, we identified 726 studies, 702 of which had to be excluded. Twenty-four cohort studies (21 retrospective, 3 prospective) were included in the analysis. No randomized trials were identified. Overall, the methodological quality was low. The 24 studies included described 466 acute perforations in which endoscopic closure was attempted. Successful endoscopic closure was achieved in 419 cases (89.9%; 95% CI, 87%-93%). Successful closure was achieved in 90.2% (n = 359; 95% CI, 87%-93%) of cases by using endoclips, in 87.8% (n = 58; 95% CI, 78%-95%) by using the over-the-scope-clip, and in 100% (n = 2) by using a metal stent. Limitations Low methodological quality of included studies. Conclusion This systematic review suggests that endoscopic perforation closure is a safe and effective alternative for surgical intervention in selected cases; however, the overall methodological quality was low. Prospective, true consecutive studies are needed to define the definitive role of endoscopic closure of perforations.
Pilot studies have indicated that peroral endoscopic myotomy (POEM) might be a safe and effective treatment for achalasia. We performed a prospective, international, multicenter study to determine ...the outcomes of 70 patients who underwent POEM at 5 centers in Europe and North America. Three months after POEM, 97% of patients were in symptom remission (95% confidence interval, 89%–99%); symptom scores were reduced from 7 to 1 ( P < .001) and lower esophageal sphincter pressures were reduced from 28 to 9 mm Hg ( P < .001). The percentage of patients in symptom remission at 6 and 12 months was 89% and 82%, respectively. POEM was found to be an effective treatment for achalasia after a mean follow-up period of 10 months. Clinical Trials Gov Registration number: NCT01405417.
Background Pneumatic dilation and laparoscopic Heller myotomy improve parameters of esophageal function such as lower esophageal sphincter (LES) pressure, esophageal emptying, and esophagogastric ...junction (EGJ) distensibility. Objective To evaluate the effect of peroral endoscopic myotomy (POEM) on esophagogastric function. Design Prospective trial. Setting Endoscopy department at a university hospital. Patients All consecutive patients aged >17 years with achalasia and an Eckardt score of ≥3. Intervention Before and 3 months after POEM, 10 consecutive patients underwent esophageal manometry, timed barium esophagograms, and EndoFLIP as well as an EGD. Main Outcome Measurements Eckardt symptom score, LES resting pressure, centimeters of barium stasis, EGJ distensibility, and reflux esophagitis. Results Compared with scores before POEM, patient symptom scores were significantly reduced (1, interquartile range IQR 0-1 vs 8 IQR 4-8; P = .005). LES pressure decreased significantly (6.0 mm Hg IQR 2.6-7.4 vs 19.0 mm Hg IQR 13.0-28.0; P = .008). Esophageal emptying increased significantly, and a 5-minute barium column measured 2.3 cm (IQR 0-3.2 cm) versus 10.1 cm (IQR 5.7-10.8 cm; P = .005). EGJ distensibility increased significantly (6.7 mm2 /mm Hg IQR 3.8-16.6 vs 1.0 mm2 /mm Hg IQR 0.4-2.3; P = .02) at 50 mL. In 6 of 10 patients, reflux esophagitis was seen. Of these patients, 3 reported reflux symptoms. Limitations Small number of patients, short-term follow-up. Conclusion POEM improves esophagogastric function and suggests favorable long-term results based on Eckardt score, esophageal manometry, esophageal emptying, and EGJ distensibility. Long-term follow-up of larger series will determine whether the high rate of reflux esophagitis affects the clinical application of POEM.
Background Endoscopic volume reduction of the stomach may provide a minimally invasive alternative for surgical procedures in the treatment of obesity. Objective To assess safety and preliminary ...effectiveness in the first human application of a novel endoscopic stapling technique. Design Prospective, observational, phase 1 study. Setting Two university hospitals in The Netherlands. Patients Patients with a body mass index (BMI) of 40 to 45 kg/m2 or 30 to 39.9 kg/m2 with obesity-related comorbidity. Interventions Gastric volume reduction with an endoscopic stapler. Main Outcome Measurements Primary outcome measure was the prevalence of serious or mild adverse events. Reduction of excess body weight after 12 months was assessed as a secondary outcome measure for effectiveness of the procedure. Results Seventeen patients with a median BMI of 40.2 kg/m2 (interquartile range IQR 37.6-42.8) underwent an endoscopic stapling procedure. Median procedure time was 123 minutes (IQR 95-129). No serious adverse events occurred. Adverse events were gastric pain (n = 7, range 1-3 days), sore throat (n = 4, 2-3 days), diarrhea (n = 4, 2-15 days), nausea (n = 3, 2-4 days), constipation (n = 4, 3-14 days), and vomiting (n = 3, 1-4 days). All adverse events were mild and resolved with conservative treatment within 15 days after surgery. The median percentage excess weight loss in the first year was 34.9% (IQR 17.8-46.6). Limitations Limited number of patients. Conclusion This first human application of this endoscopic stapler demonstrates that the procedure is technically feasible and safe. One hundred sixty plications were created in 17 patients without significant problems. Weight loss after 1 year is promising, but long-term follow-up and randomized, controlled studies should evaluate whether this procedure is an effective and durable minimally invasive endoscopic treatment for obesity. (Clinical trial registration number: NCT01429194 .)
Endoscopic treatment of obesity might be an alternative to surgical treatment or, preoperatively, serve as an auxiliary therapy to surgery in patients at increased surgical risk.
To evaluate 6-month ...safety and efficacy of the Trans-Oral Endoscopic Restrictive Implant System (TERIS) as weight-loss device.
University hospital.
Patients 18-50 years with a body mass index (BMI) of 40-50 kg/m
or 35-40 kg/m
with obesity-related co-morbidities were eligible. Included patients underwent an endoscopic creation of a gastric pouch through attachment of a silicone restrictive implant to 5 cardia plications. Main outcome measurements were safety, expressed as serious adverse events and adverse events, and efficacy, expressed as percentage of excess weight loss (EWL), weight loss (WL), and excess BMI loss (EBMIL).
Eighteen patients (3 males) with BMI of 42.1 kg/m
(interquartile range 40.3-46.9) were included. Three serious adverse events occurred (2 pneumoperitoneum, 1 perforation). Adverse events subsided spontaneously or with medication. In 62.5% of patients, the anchors remained intact for 6 months. Presented as mean (±standard deviation), excess weight loss after 6 months was 30.1% (±9.8), weight loss was 15.1% (±5.3), and excess BMI loss was 37.7% (±12.4). In those who continued the study beyond the first 6 months, weight losses could only partially be maintained due to the detachment of anchors and the unimpeded passage of food.
Three serious adverse events occurred in the first 7 patients. TERIS tolerability results improved after major changes in the system and the operating procedure. TERIS proved to be an effective 6-month treatment of obesity. As yet, because of the poor durability of the system, it cannot be recommended as a standalone endoscopic bariatric therapy. Therefore, the company decided to discontinue the TERIS system and to further develop the successful parts of it, such as the articulating circular endoscopic stapler.
Background and aims:
After Peroral Endoscopic Myotomy (POEM), the mucosal incision is closed with endoscopically applied clips. After each clip placement, a subsequent clipping device has to be ...introduced through the working channel. With the Clipmaster3, three consecutive clips can be placed without reloading which could reduce closure time. We performed a prospective study evaluating efficacy, safety, and ease of use. Closure using Clipmaster3 was compared to closure with standard clips.
Methods:
Patients undergoing closure with the Clipmaster3 were compared to patients who underwent POEM with standard clip closure.
Results:
In total, 12 consecutive POEM closures with Clipmaster3 were compared to 24 standard POEM procedures. The Clipmaster3 and the standard group did not differ in sex distribution, age (42 years 29 – 49 vs 41 years 34 – 54
P
= 0.379), achalasia subtype, disease duration, length of the mucosal incision (25.0 mm 20 – 30 vs 20.0 mm 20 – 30,
P
= 1.0), and closure time (622 seconds 438 – 909 vs 599 seconds 488 – 664
P
= 0.72). Endoscopically successful closure could be performed in all patients. The proportion of all clips used that were either displaced or discarded was larger for Clipmaster3 (8.8 %) compared to standard closure (2.0 %,
P
= 0.00782). Ease of handling VAS (visual analogue scale) score for Clipmaster3 did not differ between endoscopist and endoscopy nurse (7 out of 10).
Conclusions:
Clipmaster3 is feasible and safe for closure of mucosal incisions after POEM. Clipmaster3 was not associated with reduced closure time. Compared to standard closure, more Clipmaster3 clips were displaced or discarded to achieve successful closure. A training effect cannot be excluded as a cause of these results.
Study registration: NCT01405417
Data on the incidence and clinical relevance of gallstones in patients with suspected acute alcoholic pancreatitis are lacking and are essential to minimize the risk of recurrent acute pancreatitis. ...The aim of this study was to assess the incidence of gallstones and the associated rate of recurrent acute pancreatitis in patients with presumed acute alcoholic pancreatitis.
Between 2008 and 2019, 23 hospitals prospectively enrolled patients with acute pancreatitis. Those diagnosed with their first episode of presumed acute alcoholic pancreatitis were included in this study. The term gallstones was used to describe the presence of cholelithiasis or biliary sludge found during imaging. The primary outcome was pancreatitis recurrence during 3 years of follow-up.
A total of 334 patients were eligible for inclusion, of whom 316 were included in the follow-up analysis. Gallstone evaluation, either during the index admission or during follow-up, was performed for 306 of 334 patients (91.6%). Gallstones were detected in 54 patients (17.6%), with a median time to detection of 6 (interquartile range 0-42) weeks. During follow-up, recurrent acute pancreatitis occurred in 121 of 316 patients (38.3%), with a significantly higher incidence rate for patients with gallstones compared with patients without gallstones (59% versus 34.2% respectively; P < 0.001), while more patients with gallstones had stopped drinking alcohol at the time of their first recurrence (41% versus 24% respectively; P = 0.020). Cholecystectomy was performed for 19 patients with gallstones (36%). The recurrence rate was lower for patients in the cholecystectomy group compared with patients who did receive inadequate treatment or no treatment (5/19 versus 19/34 respectively; P = 0.038).
Gallstones were found in almost one in every five patients diagnosed with acute alcoholic pancreatitis. Gallstones were associated with a higher rate of recurrent pancreatitis, while undergoing cholecystectomy was associated with a reduction in this rate.
Several case series have demonstrated the feasibility of single-port laparoscopic ileocecal resection in Crohn's disease. However, only a few studies compared the single-port with a multiport ...laparoscopic ileocecal approach. The aim of this study was to compare short term surgical outcome parameters between single-port and multiport laparoscopic ileocecal resections for Crohn's disease.
Twenty-one patients who underwent single-port laparoscopic ileocecal resection between March 2010 and September 2012 were prospectively registered. A matched comparison on a 1:2 basis was performed with patients who underwent multiport laparoscopic ileocecal resection from January 1999 to March 2010. Matching parameters were BMI, length of diseased bowel resected and the presence of fistulas. Endpoints were the length of postoperative hospital stay, operative time, conversions, complications, postoperative pain scores and postoperative analgesia consumption.
Twenty-one patients undergoing single-port resection were matched to 42 patients undergoing multiport resection. The postoperative stay (4days, iqr 4–5 vs. 5days, iqr 4–6; p=0.033), operative time (103min, iqr 94.0–121.0 vs. 123.5min, iqr 100.0–157.0; p=0.036) and morphine use on the first postoperative day (12.5mg, iqr 5.0–33.3 vs. 28mg, 15.0–50.0; p=0.012) differed significantly. Postoperative pain scores and complications were similar in both groups. This study was limited by potential selection bias.
Single-port laparoscopic ileocecal resection is safe and feasible in Crohn's disease and is associated with less need for pain medication postoperatively as opposed to multiport laparoscopic ileocecal resection.
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