Timing of CHolecystectomy In Severe PAncreatitis (CHISPA): study protocol for a randomized controlled trial
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 o...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2024-06-01
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| Series: | BMJ Surgery, Interventions, & Health Technologies |
| Online Access: | https://sit.bmj.com/content/6/1/e000246.full |
| _version_ | 1827152637387079680 |
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| author | Camilo Ramírez-Giraldo Danny Conde Monroy José Alejandro Daza Vergara Andrés Isaza-Restrepo Isabella Van-Londoño Luisa Trujillo-Guerrero |
| author_facet | Camilo Ramírez-Giraldo Danny Conde Monroy José Alejandro Daza Vergara Andrés Isaza-Restrepo Isabella Van-Londoño Luisa Trujillo-Guerrero |
| author_sort | Camilo Ramírez-Giraldo |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-24T11:26:52Z |
| format | Article |
| id | doaj.art-834e95d614fb42fea0bdd9aa22b19f2b |
| institution | Directory Open Access Journal |
| issn | 2631-4940 |
| language | English |
| last_indexed | 2025-03-20T22:09:02Z |
| publishDate | 2024-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Surgery, Interventions, & Health Technologies |
| spelling | doaj.art-834e95d614fb42fea0bdd9aa22b19f2b2024-08-09T11:05:09ZengBMJ Publishing GroupBMJ Surgery, Interventions, & Health Technologies2631-49402024-06-016110.1136/bmjsit-2023-000246Timing of CHolecystectomy In Severe PAncreatitis (CHISPA): study protocol for a randomized controlled trialCamilo Ramírez-Giraldo0Danny Conde Monroy1José Alejandro Daza Vergara2Andrés Isaza-Restrepo3Isabella Van-Londoño4Luisa Trujillo-Guerrero5Hospital Universitario Mayor - Méderi, Bogotá, ColombiaHospital Universitario Mayor - Méderi, Bogotá, ColombiaHospital Universitario Mayor - Méderi, Bogotá, ColombiaHospital Universitario Mayor - Méderi, Bogotá, ColombiaUniversidad del Rosario, Bogota, ColombiaUniversidad del Rosario, Bogota, ColombiaAcute 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.https://sit.bmj.com/content/6/1/e000246.full |
| spellingShingle | Camilo Ramírez-Giraldo Danny Conde Monroy José Alejandro Daza Vergara Andrés Isaza-Restrepo Isabella Van-Londoño Luisa Trujillo-Guerrero Timing of CHolecystectomy In Severe PAncreatitis (CHISPA): study protocol for a randomized controlled trial BMJ Surgery, Interventions, & Health Technologies |
| title | Timing of CHolecystectomy In Severe PAncreatitis (CHISPA): study protocol for a randomized controlled trial |
| title_full | Timing of CHolecystectomy In Severe PAncreatitis (CHISPA): study protocol for a randomized controlled trial |
| title_fullStr | Timing of CHolecystectomy In Severe PAncreatitis (CHISPA): study protocol for a randomized controlled trial |
| title_full_unstemmed | Timing of CHolecystectomy In Severe PAncreatitis (CHISPA): study protocol for a randomized controlled trial |
| title_short | Timing of CHolecystectomy In Severe PAncreatitis (CHISPA): study protocol for a randomized controlled trial |
| title_sort | timing of cholecystectomy in severe pancreatitis chispa study protocol for a randomized controlled trial |
| url | https://sit.bmj.com/content/6/1/e000246.full |
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