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.

The usefulness of SpyGlass™ choledochoscopy in the diagnosis and treatment of biliary disorders.

Peroral choledochoscopy was first described in the 1970s, but the use of earlier generation choledochoscopes was significantly limited by complex equipment setup and fragility resulting in high repair costs. In late 2006, the SpyGlass Direct Visualization System (Boston Scientific Corp, Natick, MA, USA) was introduced to the market. It is a single-operator cholangioscopy platform and improves upon many shortcomings of the dual-operator systems. Currently, the two main indications for its use are evaluation of indeterminate biliary strictures and lithotripsy for difficult-to-remove biliary stones. Recently published prospective data reconfirm that the overall success rates for adequate tissue sampling and bile duct stone clearance are around 90 %, with an acceptable safety profile. The sensitivity for detecting cancer in intrinsic biliary strictures (e.g., cholangiocarcinoma) is superior to that of standard ERCP sampling modalities, but a limited yield has been noted when sampling extrinsic malignant biliary strictures (e.g., pancreatic cancer). The two main limitations of the SpyGlass system are image quality that is impeded by the use of fiberoptic technology and a relatively small accessory channel providing passage only for dedicated miniaccessories. Nevertheless, the SpyGlass platform has made single-operator cholangioscopy feasible and refined the technique in a number of important ways. This innovation has significantly expanded our diagnostic and therapeutic ERCP armamentarium. An upgraded digital imaging version is currently in development.

Prospective evaluation of gastroenterologist-guided, nurse-administered standard sedation for spiral deep small bowel enteroscopy.

BACKGROUND: Sedation of patients for deep small bowel enteroscopy presents unique challenges and is traditionally provided by anesthesiologists. No study has directly evaluated gastroenterologist-guided, nurse-administered sedation for deep enteroscopy. Further, no comparison exists between gastroenterologist-guided versus anesthesiologist-guided sedation during deep enteroscopy. AIMS: To evaluate safety and efficacy of performing deep (spiral) enteroscopy using gastroenterologist-guided sedation and compare outcomes between patients receiving gastroenterologist-guided and anesthesiologist-guided sedation. METHODS: This prospective case series contains 91 consecutive patients who underwent deep enteroscopy with spiral Endo-Ease Discovery SB overtube. Of the patients, 64 received gastroenterologist-guided and 27 received anesthesiologist-guided sedation. RESULTS: In the 64 patients receiving gastroenterologist-guided sedation, successful completion occurred in 59 of 64 enteroscopies (92.2%). Mean insertion depth was 231.0+/-85.8 cm beyond the ligament of Treitz. Total procedure time was 39.9+/-15.7 min (diagnostic time 34.7+/-12.3 min; therapy time 5.2+/-8.9 min). Positive findings were noted in 32 cases (50.0%), with therapy performed in 27 cases (42.2%). Six minor complications occurred. Compared to the anesthesiologist-guided sedation group, there was no difference in patient characteristics except mean American Society of Anesthesiologists score (2.5+/-0.5 in gastroenterologist-guided group versus 2.7+/-0.6 in anesthesiologist-guided group; p=0.046) and presence of adhesions (ten in gastroenterologist-guided group and zero in anesthesiologist-guided group; p=0.030). Outcomes for both groups were not significantly different except for shorter times in the gastroenterologist-guided group (39.9+/-15.7 min versus 46.0+/-12.1 min; p=0.047) and more frequent findings in the anesthesiologist-guided group (50.0% vs. 74.1%; p=0.034). CONCLUSIONS: Deep enteroscopy using the spiral overtube can be successfully and safely accomplished with gastroenterologist-guided, nurse-administered standard sedation.

The spiral enteroscopy training initiative: results of a prospective study evaluating the Discovery SB overtube device during small bowel enteroscopy (with video).

BACKGROUND AND AIM: Indications for small-bowel enteroscopy are increasing, but advancing the endoscope to the ileum remains challenging, especially for less experienced operators. The aim was to evaluate the ease of use, safety, and efficacy of the Discovery SB overtube (Spirus Medical, Stoughton, Massachusetts, USA) during SB enteroscopy by physicians with no experience of the device. PATIENTS AND METHODS: Thirty-three "untrained" endoscopists performed spiral enteroscopy during one of four 2-day training modules. Data were prospectively collected. Patient demographics, depth and time to maximal insertion, total procedure time, and findings were recorded. Trauma was documented during scope withdrawal. Day 1 and day 2 results were compared. RESULTS: Ninety procedures were successfully performed in 95 patients (72.6 % women, age = 48.8 +/- 14.2 years). Endoscopists each performed a mean of five procedures. Mean time to maximal insertion was 20.9 +/- 6.4 minutes. Mean depth achieved was 262.0 +/- 57.4 cm. Total procedure time was 33.6 +/- 8.0 minutes. In 90.3 %, 94.6 %, and 83.9 % of patients, respectively, a trauma score less than 3 was recorded in the esophagus, stomach, and intestine (scale = 0 - 5). There were no perforations, nor significant associations between trauma score and patient age, body mass index, depth of insertion, time to maximal insertion, total procedure time, or day 1 vs. day 2 procedures. Depth of insertion was greater on day 2 than on day 1 (276.9 +/- 53.7 cm vs. 252.0 +/- 58.0 cm, P = 0.043). CONCLUSIONS: Discovery SB provides safe advancement of the enteroscope into the distal small bowel. Maximum depth of insertion appears comparable to that of balloon enteroscopy while taking less time. The device is easy to use and may be effectively operated in as few as five training cases.