Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202306789614899 Date of Approval: 23/06/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Necrotizing biliary pancreatitis: time for cholecystectomy
Official scientific title Necrotizing biliary pancreatitis: time for cholecystectomy randomised controlled trial (NBPTC)
Brief summary describing the background and objectives of the trial 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 TUNISIA Time for cholecystectomy is a controversial subject, There is No consensus with a high level of evidence We 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  Early cholecystectomy = during the same hospitalisation (within 15 days of symptomatology).  Delayed cholecystectomy = after restitution ad integrum of the necrosis flows. Our Primary endpoint: perioperative complications (hemorrhage, biliary wound and superinfection of necrosis flows)
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 05/06/2023
Actual trial start date 05/06/2023
Anticipated date of last follow up 30/06/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 92
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Early Cholecystectomy within 15 days of the onset of symptoms We will practice an Early laparoscopic cholecystectomy during the same hospital stay of the acute necrotizing panceatitis (within 15 days of the onset of symptoms). 46
Control Group Delayed Cholecystectomy after 15 days at least from beginig of symptoms We will practice a delayed laparoscopic cholecytectomy after that the necrosis flows have been restored ad integrum. 46 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients with moderate acute necrotising pancreatitis of biliary origin patients >18 years old ASA1 and 2 ASA score 3 and 4 Patients who have had a cholecystectomy Persistent fever >48h or CRP>150mg/L or increasing kinetics between d1-5 Severe acute pancreatitis with persistent visceral failure >48h Patients with a local complication (acute cholecystitis, acute angiocholitis, digestive perforation, thrombosis, etc.) Patients with associated lithiasis of the main bile duct diagnosed preoperatively. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 90 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 25/05/2023 University hospital mongi slim ethical committee
Ethics Committee Address
Street address City Postal code Country
Sidi daoud Tunis 2046 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Peri-operative complications (haemorrhage, biliary wound and superinfection of necrosis flows) up to 30 days after surgery
Secondary Outcome Conversion rate Operating time Length of hospital stay Occurrence of biliary events between diagnosis and surgery Mortality up to 90 days from the symptoms
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
General Surgery Department Mongi Slim Hospital Sidi Daoud LaMarsa Tunis 2065 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Yes Mongi Slim university Hospital, SIdi Daoud Tunis 2065 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mongi Slim university Hospital LaMarsa Sidi Daoud Tunis 2046 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Zied Hadrich hadrich1988@gmail.com +21654420839 Mustapha Kamel Dar Chaabane
City Postal code Country Position/Affiliation
Nabeul 8075 Tunisia Surgery Department Mongi Slim University hospital
Role Name Email Phone Street address
Scientific Enquiries Hafedh Mestiri hafedh.mestiru@rns.tn +21699333464 LaMarsa
City Postal code Country Position/Affiliation
Tunis 2046 Tunisia Surgery Department Mongi Slim University Hospital
Role Name Email Phone Street address
Public Enquiries Sahir Omrani sahir.omrani@gmail.com +21692783952 LaMarsa
City Postal code Country Position/Affiliation
Tunis 2046 Tunisia Surgery Department Mongi Slim University Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual patient Data with study protocol and Statistical Analysis Plan after de-identification will be available. Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 10 Months and ending 36 months after article publication. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and researchers who provide a methodologically sound proposal directed to "zied.hadrich@fmt.utm.tn" and will be provided following review and approval of execution of a Data Sharing Agreement.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information