Prophylaxis Against Post-Endoscopic Retrograde Cholangio-Pancreatography Pancreatitis.

NCT07599605 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: 0344/24
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Endoscopic retrograde cholangiopancreatography (ERCP) is a key procedure for managing biliopancreatic diseases, although it is associated with complications such as post-ERCP pancreatitis. This study assessed the efficacy of a prophylactic protocol combining rectal indomethacin with aggressive hydration to reduce the incidence of post-ERCP pancreatitis and serum amylase and lipase levels.

Conditions

Pancreatitis; ERCP

Keywords

ERCP; Rectal indomethacin; Hydration; Post-ERCP pancreatitis; Prophylaxis; Amylase; Lipase; Biliopancreatic complications

Outcome Measures

Primary Outcomes (2)

• Post-ERCP pancreatitis

  Pancreas inflammation after the ERCP procedure

  From the end of the ERCP procedure through 24 hours

• Post-ERCP pancreatitis

  Pancreas inflammation due to the ERCP procedure

  Ocurring in the first 24 hours posterior to the ERCP

Secondary Outcomes (1)

• Post-ERCP Pancreatic enzyme elevation

  Ocurring in the first 24 hours posterior to the ERCP

Study Arms (2)

Control Group

NO INTERVENTION

The control group underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) without prophylactic treatment

Prophylaxis Group

EXPERIMENTAL

The prophylaxis group received 100 mg of rectal indomethacin 30 minutes before the Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure, combined with intravenous Hartmann's solution administered at 3 mL/kg/hr during the procedure, plus a 20 mL/kg bolus given post-procedure, followed by continuous hydration at 3 mL/kg/hr for 8 hours

Drug: Rectal Indometacin

Interventions

Rectal Indometacin DRUG

The gold standard for treating diseases affecting the biliopancreatic ducts, choledocholithiasis being the most common indication, for which sphincterotomy is the most frequently performed procedure.

Also known as: ERCP

Prophylaxis Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who required ERCP
• Without contraindications to the use of indomethacin or aggressive hydration

You may not qualify if:

• Patients with cardiac or renal alterations

Sponsors & Collaborators

• Hospital General de Chihuahua - Dr. Salvador Zubirán Anchondo: lead

Study Sites (1)

Chihuahua City General Hospital "Dr. Salvador Zubirán Anchondo"

Chihuahua City, Chihuahua, 31000, Mexico

Location

Related Publications (7)

• Aghajanpoor Pasha M, Eslami P, Dooghaie Moghadam A, Moazzami B, Shojaee S, Almasi F, Tavakolikia N, Norouzinia M, Radinnia E, Sadeghi A. The synergistic impact of NSAIDs and aggressive hydration therapy on the rate of post-ERCP pancreatitis in high -risk and low -risk patients. Gastroenterol Hepatol Bed Bench. 2020 Winter;13(Suppl1):S81-S88.

  PMID: 33585008 BACKGROUND

• Aljohani S, Mirghani H. Aggressive Hydration With Ringer's Lactate in the Prevention of Post-ERCP Pancreatitis: A Meta-Analysis. Cureus. 2021 May 7;13(5):e14897. doi: 10.7759/cureus.14897.

  PMID: 34109084 BACKGROUND

• Wan J, Ren Y, Zhu Z, Xia L, Lu N. How to select patients and timing for rectal indomethacin to prevent post-ERCP pancreatitis: a systematic review and meta-analysis. BMC Gastroenterol. 2017 Mar 15;17(1):43. doi: 10.1186/s12876-017-0599-4.

  PMID: 28298192 BACKGROUND

• Goyal H, Sachdeva S, Sherazi SAA, Gupta S, Perisetti A, Ali A, Chandan S, Tharian B, Sharma N, Thosani N. Early prediction of post-ERCP pancreatitis by post-procedure amylase and lipase levels: A systematic review and meta-analysis. Endosc Int Open. 2022 Jul 15;10(7):E952-E970. doi: 10.1055/a-1793-9508. eCollection 2022 Jul.

  PMID: 35845027 BACKGROUND

• Cahyadi O, Tehami N, de-Madaria E, Siau K. Post-ERCP Pancreatitis: Prevention, Diagnosis and Management. Medicina (Kaunas). 2022 Sep 12;58(9):1261. doi: 10.3390/medicina58091261.

  PMID: 36143938 BACKGROUND

• Easler JJ, Fogel EL. Prevention of post-ERCP pancreatitis: the search continues. Lancet Gastroenterol Hepatol. 2021 May;6(5):336-337. doi: 10.1016/S2468-1253(21)00063-7. Epub 2021 Mar 19. No abstract available.

  PMID: 33740414 BACKGROUND

• Borrelli de Andreis F, Mascagni P, Schepis T, Attili F, Tringali A, Costamagna G, Boskoski I. Prevention of post-ERCP pancreatitis: current strategies and novel perspectives. Ther Adv Gastroenterol. 2023 Mar 6;16:17562848231155984. doi: 10.1177/17562848231155984. eCollection 2023.

  PMID: 36895283 BACKGROUND

MeSH Terms

Conditions

Pancreatitis

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Rubén Cuevas-Martínez, MD, MSc

  Chihuahua City General Hospital "Dr. Salvador Zubirán Anchondo"

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc

Model Details: To determine if a prophylactic dose of rectal indomethacin plus an aggressive hydration scheme reduces the incidence of post-ERCP pancreatitis, a randomized controlled study (RCT) was designed in the surgery department of a secondary-care teaching hospital.

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: May 20, 2026
• Study Start: March 4, 2024
• Primary Completion: December 27, 2024
• Study Completion: January 17, 2025
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)