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LACTATED RINGER’S SOLUTION IN COMBINATION WITH RECTAL INDOMETHACIN FOR PREVENTION OF POST-ERCP PANCREATITIS: A PROSPECTIVE RANDOMIZED, DOUBLE-BLINDED, CONTROLLED TRIAL

LACTATED RINGER’S SOLUTION IN COMBINATION WITH RECTAL INDOMETHACIN FOR PREVENTION OF POST-ERCP PANCREATITIS: A PROSPECTIVE RANDOMIZED, DOUBLE-BLINDED, CONTROLLED TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202201712208274
Enrollment
210
Registered
2022-01-06
Start date
2022-01-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Digestive System

Interventions

lactated ringer alone
indomethacin
indomethacin and lactated ringer

Sponsors

Mohammed seghir nekache hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
The primary study outcome was Post ERCP Pancreatitis

Secondary

MeasureTime frame
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.

Countries

Algeria

Contacts

Public ContactKhellaf AMALOU

Professor in gastroenterology

amalou_kh@yahoo.fr00213661615850

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026