Takao Itoi1, Hiroshi Kawakami2, Akio Katanuma3, Atsushi Irisawa4, Atsushi Sofuni1, Fumihide Itokawa1, Takayoshi Tsuchiya1, Reina Tanaka5, Junko Umeda1, Shomei Ryozawa6, Shinpei Doi2, Naoya Sakamoto2, Ichiro Yasuda7. 1. Department of Gastroenterology and Hepatology, Tokyo Medical University, Tokyo, Japan. 2. Department of Gastroenterology and Hepatology, Hokkaido University Graduate School of Medicine, Sapporo, Japan. 3. Center for Gastroenterology, Teine-Keijinkai Hospital, Sapporo, Japan. 4. Department of Gastroenterology, Aizu Medical Center, Fukushima Prefectural Medical College, Fukushima, Japan. 5. Department of Gastroenterology, Toda Chuo General Hospital, Saitama, Japan. 6. Department of Gastroenterology, Saitama Medical University International Medical Center, Saitama, Japan. 7. Department of Gastroenterology, Teikyo University Mizonokuchi Hospital, Kawasaki, Japan.
Abstract
BACKGROUND: There are currently no prospective, controlled trials of endoscopic transpapillary gallbladder drainage in patients with acute cholecystitis. OBJECTIVE: We evaluated the technical success rate and efficacy of endoscopic transpapillary gallbladder drainage by using either endoscopic nasogallbladder drainage (ENGBD) or endoscopic gallbladder stenting (EGBS) for patients with acute cholecystitis. DESIGN: Randomized, controlled study. SETTING:Tertiary-care referral centers. PATIENTS: Seventy-three consecutive patients with acute cholecystitis were randomized. INTERVENTIONS:ENGBD by using a 5F or 7F tube (n = 37) or EGBS (n = 36) by using a 7F stent. MAIN OUTCOME AND MEASUREMENTS: Technical success, clinical success, adverse events, and procedure-related pain score. RESULTS: The overall technical success rates in the ENGBD and EGBS groups were 91.9% and 86.1%, respectively (P > .05). The mean procedure times of ENGBD and EGBS were 20.3 ± 12.1 and 22.2 ± 14.5 minutes, respectively (P > .05). The overall clinical success rates by per protocol analysis were 94.1% and 90.3% in the ENGBD and EGBS groups, respectively, whereas the rates by intention-to-treat analysis were 86.5% and 77.8%, respectively (P > .05). Moderate adverse events were observed in the ENGBD (n = 2) and EGBS (n = 1) groups. The mean visual analog score of postprocedure pain in the ENGBD group was significantly higher than that in the EGBS group (1.3 ± 1.1 vs 0.4 ± 0.8, respectively; P < .001). LIMITATIONS: Small sample size and the participation of multiple endoscopists who may have different levels of experience in endoscopic transpapillary gallbladder drainage. CONCLUSIONS: Both ENGBD and EGBS appear to be suitable for the treatment of acute cholecystitis in patients who are poor candidates for emergency cholecystectomy. ( CLINICAL TRIAL REGISTRATION NUMBER: UMIN000012316.).
RCT Entities:
BACKGROUND: There are currently no prospective, controlled trials of endoscopic transpapillary gallbladder drainage in patients with acute cholecystitis. OBJECTIVE: We evaluated the technical success rate and efficacy of endoscopic transpapillary gallbladder drainage by using either endoscopic nasogallbladder drainage (ENGBD) or endoscopic gallbladder stenting (EGBS) for patients with acute cholecystitis. DESIGN: Randomized, controlled study. SETTING: Tertiary-care referral centers. PATIENTS: Seventy-three consecutive patients with acute cholecystitis were randomized. INTERVENTIONS: ENGBD by using a 5F or 7F tube (n = 37) or EGBS (n = 36) by using a 7F stent. MAIN OUTCOME AND MEASUREMENTS: Technical success, clinical success, adverse events, and procedure-related pain score. RESULTS: The overall technical success rates in the ENGBD and EGBS groups were 91.9% and 86.1%, respectively (P > .05). The mean procedure times of ENGBD and EGBS were 20.3 ± 12.1 and 22.2 ± 14.5 minutes, respectively (P > .05). The overall clinical success rates by per protocol analysis were 94.1% and 90.3% in the ENGBD and EGBS groups, respectively, whereas the rates by intention-to-treat analysis were 86.5% and 77.8%, respectively (P > .05). Moderate adverse events were observed in the ENGBD (n = 2) and EGBS (n = 1) groups. The mean visual analog score of postprocedure pain in the ENGBD group was significantly higher than that in the EGBS group (1.3 ± 1.1 vs 0.4 ± 0.8, respectively; P < .001). LIMITATIONS: Small sample size and the participation of multiple endoscopists who may have different levels of experience in endoscopic transpapillary gallbladder drainage. CONCLUSIONS: Both ENGBD and EGBS appear to be suitable for the treatment of acute cholecystitis in patients who are poor candidates for emergency cholecystectomy. ( CLINICAL TRIAL REGISTRATION NUMBER: UMIN000012316.).
Authors: Thomas R McCarty; Kelly E Hathorn; Ahmad Najdat Bazarbashi; Kunal Jajoo; Marvin Ryou; Christopher C Thompson Journal: Surg Endosc Date: 2021-07-06 Impact factor: 4.584