Aggressive intravenous hydration with lactated Ringer's solution for prevention of post-ERCP pancreatitis: a prospective randomized multicenter clinical trial.

BACKGROUND AND STUDY AIMS : The present study aimed to determine the type of intravenous hydration that is best suited to reducing the incidence of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis. PATIENTS AND METHODS: In a prospective randomized multicenter trial, average-to-high risk patients who underwent first-time ERCP were randomly assigned to three groups (1:1:1) who received: aggressive intravenous hydration (3 mL/kg/h during ERCP, a 20-mL/kg bolus and 3 mL/kg/h for 8 hours after ERCP) with either lactated Ringer's solution (LRS) or normal saline solution (NSS), or standard intravenous hydration with LRS (1.5 mL/kg/h during and for 8 hours after ERCP). The primary end point was post-ERCP pancreatitis (PEP). RESULTS: 395 patients were enrolled, and 385 completed the protocols. The three groups showed no significant differences in demographic characteristics. There was a significant difference in the intention-to-treat (ITT) PEP rate between the aggressive LRS group (3.0 %, 95 % confidence interval [CI] 0.1 % - 5.9 %; 4 /132), the aggressive NSS group (6.7 %, 95 %CI 2.5 % - 10.9 %; 9 /134) and the standard LRS group (11.6 %, 95 %CI 6.1 % - 17.2 %; 15 /129; P = 0.03). In the two-group comparisons, the ITT PEP rate was significantly lower for the aggressive LRS group than for the standard LRS group (relative risk [RR] 0.26, 95 %CI 0.08 - 0.76; P = 0.008). There was no significant difference in the ITT PEP rate between the aggressive NSS group and the standard LRS group (RR 0.57, 95 %CI 0.26 - 1.27; P = 0.17). CONCLUSION: Aggressive hydration with LRS is the best approach to intravenous hydration for the prevention of PEP in average-to-high risk patients.

Learning colorectal endoscopic submucosal dissection: a prospective learning curve study using a novel ex vivo simulator.

BACKGROUND: Endoscopic submucosal dissection (ESD) is increasingly being used in Asia as a minimally invasive therapy to eradicate large laterally spreading superficial tumors in the colon. To date, the learning curve and effectiveness of ex vivo simulators in colonic ESD training remain unclear. The aim of the study is to determine the learning curve of colonic ESD in an ex vivo simulator. METHODS: We conducted a prospective study of colon ESD in ex vivo porcine colons in a prototype simulator. Three endoscopists with prior experience in gastric ESD but with no experience in colonic ESD each performed 30 ESD resections on standardized lesions in the rectosigmoid and left colon of the porcine simulator. Procedure time, en bloc resection status, and perforation were recorded. RESULTS: All 90 lesions were resected using the ESD technique. The mean time of procedure was 49.6 min (standard deviation 29.6 min). The aggregate rate of perforation was 14.4% and the aggregate rate of non-en bloc resection was 5.6%. Using a composite quality score integrating complications and procedural time, it was found that there was a significant difference between two local polynomial regression lines when using a cut-point at the 9th procedure (p = 0.04), reflecting the point at which most of the learning curve is traversed. CONCLUSIONS: In this study, there were significant improvements realized in colonic ESD performance after 9 colon ESD procedures in ex vivo specimens. Although training will depend on endoscopist skill and expertise, we suggest at least 9 ex vivo procedures prior to moving to live animal or proctored training in colonic ESD.

Prospective randomized comparison of gastrotomy closure associating tunnel access and over-the-scope clip (OTSC) with two other methods in an experimental ex vivo setting.

BACKGROUND: Safe transgastric natural orifice transluminal endoscopic surgery (NOTES) procedures require a reliable closure of the gastrotomy. Recently a novel peritoneal access method via a submucosal tunnel has been described with encouraging preliminary results. AIM: The aim is to compare a submucosal tunnel access plus over-the-scope clip (OTSC) system for closure with two other closure modalities. PATIENTS AND METHODS: This is a prospective ex vivo study conducted on 42 porcine stomach models equally randomized into three groups in an academic medical center. The procedures performed in each group included: (1) Tunnel (6 cm) + endoclips; (2) Knife + balloon dilation access + OTSC; and (3) Tunnel + OTSC. A pressurized air-leak test was performed to evaluate the strength of the closure. Stomach volumes, procedure times, number of clips, and incision sizes were also registered. RESULTS: The mean air-leak pressure was statistically higher in Group 3 than in Groups 1 and 2-95.2 ±â€Š19.3 mmHg versus 72.5 ±â€Š35.2 and 79.0 ±â€Š24.5 mmHg (P < 0.05). The gastrotomy creation times for Groups 1, 2, and 3 were 28.0 ±â€Š10.1, 4.3 ±â€Š1.4, and 20.1 ±â€Š10.6 minutes, respectively, with significantly lower time in Group 2 (P < 0.001). The closure times were 16.1 ±â€Š6.1, 6.5 ±â€Š1.2, and 5.3 ±â€Š3.0 minutes, respectively, and significantly longer in the endoclip group (P < 0.001). There were no differences in the volumes and the incision sizes among the three groups. CONCLUSION: The combination of a submucosal tunnel access and OTSC offers a stronger closure than the other methods studied.

Erratum: Prospective randomized comparison of gastrotomy closure associating tunnel access and over-the-scope clip (OTSC) with two other methods in an experimental ex vivo setting.

[This corrects the article DOI: 10.1055/s-0034-1390794.].