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.: PACTR202201712208274 Date of Approval: 06/01/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title LACTATED RINGER’S SOLUTION IN COMBINATION WITH RECTAL INDOMETHACIN FOR PREVENTION OF POST-ERCP PANCREATITIS: A PROSPECTIVE RANDOMIZED, DOUBLE-BLINDED, CONTROLLED TRIAL
Official scientific title LACTATED RINGER’S SOLUTION IN COMBINATION WITH RECTAL INDOMETHACIN FOR PREVENTION OF POST-ERCP PANCREATITIS: A PROSPECTIVE RANDOMIZED, DOUBLE-BLINDED, CONTROLLED TRIAL
Brief summary describing the background and objectives of the trial Acute pancreatitis is a potential ERCP adverse event, resulting in substantial medical costs and patient morbidity. Post-ERCP pancreatitis (PEP) incidence varies widely in the literature, with rates ranging from 1% to 10% for low-risk individuals to 30% without prophylaxis for individuals with high-risk factors. Based on findings of randomized trials and recommendations by the ESGE and the ASGE, IND is widely used as a preventive strategy for PEP. The use of an infusion of lactated Ringer’s solution (LR) has shown a benefit in the prevention of acute pancreatitis. The aim is to evaluate the efficacy of IND with or without bolus LR in patients at high-risk for PEP.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Digestive System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/01/2022
Actual trial start date
Anticipated date of last follow up 01/11/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 210
Actual target sample size (number of participants)
Recruitment status Not yet 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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group lactated ringer alone 1-L of LR infusion within a 30-minute time period. And 3 ml/Kg/h during and at least four hours after the procedure once prevention of post ERCP pancreatitis 70
Control Group indomethacin 100mg once prevention post ERCP pancreatitis 70 Active-Treatment of Control Group
Experimental Group indomethacin and lactated ringer 100 mg of indomethacin and 1-L of LR infusion within a 30-minute time period. And 3 ml/Kg/h during and at least four hours after the procedure once prevention of post ERCP pancreatitis 70
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
historical criterion of high risk for PEP before the procedure. major criteria included 1 of the following: suspicion for sphincter of Oddi dysfunction, personal history of PEP, more than 8 cannulation attempts, precut sphincterotomy, endoscopic papillary balloon dilation of an intact sphincter, endoscopic PD sphincterotomy. Patients were also included if they met 2 or more of the following minor criteria: female sex and age under 50 years, personal history of recurrent acute pancreatitis, PD injection leading to “acinarization” or over 3 PD injections, and PD cytology acquisition. age under 18 years, pregnancy, active acute pancreatitis. true documented allergy to or use in the day of the procedure of NSAIDs, acute renal failure, active peptic ulcer disease. Contraindications to aggressive IVF hydration. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 80 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
No 02/12/2021 Ethics Committee of the faculty of Medicine of Algiers
Ethics Committee Address
Street address City Postal code Country
BENAKNOUN Algiers 16000 Algeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary study outcome was Post ERCP Pancreatitis 30 days
Secondary Outcome Secondary outcomes included severe acute pancreatitis (persistent organ failure ! 48 hours), localized AEs (pseudocyst formation, abscess, walled of pancreatic necrosis), death, length of hospital stay in days, and readmission within 30 days. All patients were kept in the recovery area for 4 hours after completion of their ERCP, participants received a telephone call within 24 hours and also at 30 days from their procedure. 30 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mohammed seghir nekache hospital Kouba Algiers 16000 Algeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Hospital KOUBA ALGIERS 16000 Algeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mohammed seghir nekache hospital Kouba Algiers 16000 Algeria Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Khellaf AMALOU amalou_kh@yahoo.fr 00213661615850 Kouba
City Postal code Country Position/Affiliation
Algiers 16000 Algeria Professor in gastroenterology
Role Name Email Phone Street address
Public Enquiries Khellaf AMALOU amalou_kh@yahoo.fr 00213661615850 Kouba
City Postal code Country Position/Affiliation
Algiers 16000 Algeria Professor in gastroenterology
Role Name Email Phone Street address
Scientific Enquiries Khellaf AMALOU amalou_kh@yahoo.fr 0021361615850 Kouba
City Postal code Country Position/Affiliation
Algiers 16000 Algeria Professor in gastroenterology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participant data collected during the trial, after deidentification including data that underlie the results (text, tables, figures, and appendices) will be reported in this study. Informed Consent Form Beginning 2 months and ending 5 years following article publication Proposals should be directed to amalou_kh@yahoo.fr. Researchers who provide a methodologically sound proposal may request access. The data can be used to achieve aims in the approved proposal.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Link To Protocol 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