TY - JOUR
T1 - Timing of CHolecystectomy In Severe PAncreatitis (CHISPA)
T2 - study protocol for a randomized controlled trial
AU - Ramírez-Giraldo, Camilo
AU - Monroy, Danny Conde
AU - Vergara, José Alejandro Daza
AU - Isaza-Restrepo, Andrés
AU - Van-Londoño, Isabella
AU - Trujillo-Guerrero, Luisa
N1 - © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
PY - 2024/3/7
Y1 - 2024/3/7
N2 - Acute pancreatitis is the recurrent reason for gastrointestinal admission in a clinical urgent setting, it happens secondary to a wide array of pathologies out of which biliary disease stands as one of the most frequent causes for its presentation. Approximately 20% of pancreatitis are of moderate or severe severity. Currently, there is not a clear recommendation on timing for cholecystectomy, either early or delayed. CHISPA is a randomized controlled, parallel-group, superior clinical trial. An intention-to-treat analysis will be performed. It seeks to evaluate differences between patients taken to early cholecystectomy during hospital admission (72 hours after randomization) versus delayed cholecystectomy (30±5 days after randomization). The primary endpoint is major complications associated with laparoscopic cholecystectomy defined as a Clavien-Dindo score of over III/V during the first 90 days after the procedure. Secondary endpoints include recurrence of biliary disease, minor complications (Clavien-Dindo score below III/V), days of postoperative hospital stay, and length of stay in an intensive therapy unit postoperatively (if it applies). The CHISPA trial has been designed to demonstrate that delayed laparoscopic cholecystectomy reduces the rate of complications associated to an episode of severe biliary pancreatitis compared to early laparoscopic cholecystectomy.Trial registration number: NCT06113419.
AB - Acute pancreatitis is the recurrent reason for gastrointestinal admission in a clinical urgent setting, it happens secondary to a wide array of pathologies out of which biliary disease stands as one of the most frequent causes for its presentation. Approximately 20% of pancreatitis are of moderate or severe severity. Currently, there is not a clear recommendation on timing for cholecystectomy, either early or delayed. CHISPA is a randomized controlled, parallel-group, superior clinical trial. An intention-to-treat analysis will be performed. It seeks to evaluate differences between patients taken to early cholecystectomy during hospital admission (72 hours after randomization) versus delayed cholecystectomy (30±5 days after randomization). The primary endpoint is major complications associated with laparoscopic cholecystectomy defined as a Clavien-Dindo score of over III/V during the first 90 days after the procedure. Secondary endpoints include recurrence of biliary disease, minor complications (Clavien-Dindo score below III/V), days of postoperative hospital stay, and length of stay in an intensive therapy unit postoperatively (if it applies). The CHISPA trial has been designed to demonstrate that delayed laparoscopic cholecystectomy reduces the rate of complications associated to an episode of severe biliary pancreatitis compared to early laparoscopic cholecystectomy.Trial registration number: NCT06113419.
UR - http://www.scopus.com/inward/record.url?scp=85187500563&partnerID=8YFLogxK
UR - https://www.mendeley.com/catalogue/f6621839-3160-3148-9967-a4357cb22f80/
U2 - 10.1136/bmjsit-2023-000246
DO - 10.1136/bmjsit-2023-000246
M3 - Artículo
C2 - 38463464
AN - SCOPUS:85187500563
SN - 2631-4940
VL - 6
SP - e000246
JO - BMJ Surgery, Interventions, and Health Technologies
JF - BMJ Surgery, Interventions, and Health Technologies
IS - 1
M1 - e000246
ER -