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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.<\/jats:p><jats:p>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\u00b15 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).<\/jats:p><jats:p>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:<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT06113419\">NCT06113419<\/jats:ext-link>.<\/jats:p>","DOI":"10.1136\/bmjsit-2023-000246","type":"journal-article","created":{"date-parts":[[2024,3,7]],"date-time":"2024-03-07T11:25:36Z","timestamp":1709810736000},"page":"e000246","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":2,"title":["Timing of CHolecystectomy In Severe PAncreatitis (CHISPA): study protocol for a randomized controlled trial"],"prefix":"10.1136","volume":"6","clinical-trial-number":[{"clinical-trial-number":"nct06113419","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1929-2299","authenticated-orcid":false,"given":"Camilo","family":"Ram\u00edrez-Giraldo","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Danny","family":"Conde Monroy","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jos\u00e9 Alejandro","family":"Daza Vergara","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andr\u00e9s","family":"Isaza-Restrepo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Isabella","family":"Van-Londo\u00f1o","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Luisa","family":"Trujillo-Guerrero","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2024,3,7]]},"reference":[{"key":"2024051514380793000_6.1.e000246.1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2021.09.043"},{"key":"2024051514380793000_6.1.e000246.2","doi-asserted-by":"crossref","first-page":"118","DOI":"10.20452\/pamw.1627","article-title":"Revision of the Atlanta classification of acute pancreatitis","volume":"123","author":"Sarr","year":"2012","journal-title":"Pol Arch Med Wewn"},{"key":"2024051514380793000_6.1.e000246.3","doi-asserted-by":"publisher","DOI":"10.1002\/jhbp.259"},{"key":"2024051514380793000_6.1.e000246.4","doi-asserted-by":"crossref","DOI":"10.1186\/s13017-019-0247-0","article-title":"WSES guidelines for the management of severe acute pancreatitis","volume":"14","author":"Lepp\u00e4niemi","year":"2019","journal-title":"World J Emerg Surg"},{"key":"2024051514380793000_6.1.e000246.5","doi-asserted-by":"crossref","first-page":"1359","DOI":"10.1007\/s00268-022-06501-4","article-title":"Early versus delayed cholecystectomy for acute biliary pancreatitis: a systematic review and meta-analysis","volume":"46","author":"Prasanth","year":"2022","journal-title":"World J Surg"},{"key":"2024051514380793000_6.1.e000246.6","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra1505202"},{"key":"2024051514380793000_6.1.e000246.7","doi-asserted-by":"publisher","DOI":"10.1097\/01.sla.0000128688.97556.94"},{"key":"2024051514380793000_6.1.e000246.8","doi-asserted-by":"crossref","first-page":"935","DOI":"10.1097\/MPA.0000000000001601","article-title":"The role of laparoscopic cholecystectomy after severe and\/or necrotic pancreatitis in the setting of modern minimally invasive management of pancreatic necrosis","volume":"49","author":"Ackermann","year":"2020","journal-title":"Pancreas"},{"key":"2024051514380793000_6.1.e000246.9","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-158-3-201302050-00583"},{"key":"2024051514380793000_6.1.e000246.10","doi-asserted-by":"publisher","DOI":"10.1097\/01.sla.0000133083.54934.ae"},{"key":"2024051514380793000_6.1.e000246.11","unstructured":"Pantoja Burbano SM , Freire Holgu\u00edn KM , Cabrera Vargas LF , et al . 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