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Necrotizing biliary pancreatitis: time for cholecystectomy - Trial PACTR202306789614899

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PACTR202306789614899
Not Applicable
Recruiting
procedure
Trial Details
Pan Africa Clinical Trials Registry โ€ข PACTR202306789614899
Pure Global
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Necrotizing biliary pancreatitis: time for cholecystectomy
Necrotizing biliary pancreatitis: time for cholecystectomy randomised controlled trial (NBPTC)

Study Focus

Surgery

procedure

Sponsor & Location

Mongi Slim university Hospital LaMarsa

Yes

Tunisia

Timeline & Enrollment

Not Applicable

Jun 05, 2023

Jan 01, 1900

Summary

Acute necrotizing or necrotic-hemorrhagic pancreatitis accounts for 10-25% of all forms of acute pancreatitis, with High mortality and morbidity due to Multi-visceral failure syndrome and Superinfection of necrosis.Biliary origin most frequent in TUNISIATime for cholecystectomy is a controversial subject, There is No consensus with a high level of evidenceWe classically wait the ad integrum restitution of flows (about 3 months) to do the cholecystectomy, but in this time many patients develop recurrent pancreatitis, which is usually more severe before undergoing cholecystectomy. We propose to conduct a randomised, single-blind, unilateral controlled trial to assess the safety of early cholecystectomy in acute necrotising pancreatitis compared with late cholecystectomy. o Treatment tested (Group A): early cholecystectomy o Control group (Group B): delayed cholecystectomy๏‚ง Early cholecystectomy = during the same hospitalisation (within 15 days of symptomatology).๏‚ง Delayed cholecystectomy = after restitution ad integrum of the necrosis flows.Our Primary endpoint:perioperative complications (hemorrhage, biliary wound and superinfection of necrosis flows)

ICD-10 Classifications

Other surgical procedures
Surgical procedure, unspecified
During surgical operation
During surgical operation
During surgical operation

Data Source

Pan Africa Clinical Trials Registry

PACTR202306789614899

Non-Device Trial