Indomethacin Decreases Post-ERCP Pancreatitis

NCT02110810 | Completed Phase 3 DMC

• 1 other identifier: Indomethacin-2014-02
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Endoscopic retrograde cholangiopancreatography (ERCP) is now a widely accepted therapy for treating benign and malignant diseases of the pancreatobiliary tree. Acute pancreatitis represents the most common and feared complication following ERCP. The reported incidence of this complication is from 1% to 40% according to the presence of high-risk factors for this complication or the presence dysfunction in the sphincter of Oddi (SOD). In most prospective series, the incidence has ranged between 3.5% and 20% for nonselected and high-risk patients, respectively. Independent risk factors for post-ERCP pancreatitis are either patient- or procedure-related.

Conditions

Post ERCP Acute Pancreatitis

Keywords

post-ERCP Acute Pancreatitis; Indomethacin; NSAIDs

Outcome Measures

Primary Outcomes (1)

• Post ERCP Acute Pancreatitis

  Defined as the development of new or increased abdominal pain consistent with pancreatitis, and elevated blood amylase or lipase \>3 times the upper limit of normal until 24 h after the procedure, and hospitalization (or prolongation of existing hospitalization) for at least 2 nights.

  48 hours after the procedure.

Secondary Outcomes (5)

• Severity of post-ERCP pancreatitis

  48 hours after procedure.

• Acute Pancreatitis

  During 30 days after hospital discharge.

• Asymptomatic hyperamylasemia

  48 hours after procedue.

• Measurement of serum amylase

  2 hours post-ERCP

• Routine laboratory examinations

  2 hours after procedure and daily until hospital discharge, an expected average of 10 days.

Study Arms (2)

Indomethacin

EXPERIMENTAL

100 mg of Indomethacin suppository immediately afterwards while still under sedation

Drug: Indomethacin

2.6-g suppository of glycerin

PLACEBO COMPARATOR

suppository of 2.4 g of glycerin immediately afterwards while still under sedation

Drug: 2.6-g suppository of glycerin

Interventions

Indomethacin DRUG

Indomethacin suppository of 100 mg immediately afterwards while still under sedation

Indomethacin

2.6-g suppository of glycerin DRUG

to receive a 2.4 g of glycerin suppository immediately afterwards while still under sedation

Also known as: glycerin suppository

2.6-g suppository of glycerin

Eligibility Criteria

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

You may qualify if:

• If they met one or more of the following criteria:
• a clinical suspicion of SOD dysfunction;
• or a history of post-ERCP pancreatitis, pancreatic
• or precut sphincterotomy,
• more than eight cannulation attempts,
• pneumatic dilatation of an intact biliary sphincter,
• or ampullectomy
• aged 50 years or younger and female gender
• or a history of recurrent pancreatitis (\>2 episodes),
• three or more injections of contrast agent into the pancreatic duct with at least one injection to the tail of the pancreas,
• excessive injection of contrast agent into the pancreatic duct resulting in opacification of pancreatic acini,
• or the need for acquisition of a cytology specimen from the pancreatic duct with the use of a tissue-sampling brush.

You may not qualify if:

• unwillingness or inability to consent for the study
• pregnancy
• breast feeding
• standard contraindications for ERCP
• hypersensitivity to aspirin or NSAIDs
• previous use of NSAIDs within 1 week
• renal failure (creatinine clearance rate \>1.4 mg/dL)
• active or recent (\< 4 weeks) gastrointestinal hemorrhage
• chronic calcified pancreatitis
• pancreatic head malignancy
• any procedure performed on the major papilla/ventral pancreatic duct in patients with a pancreatic divisum
• previous ERCP for biliary stent removal or exchange without an anticipated pancreatogram
• subjects with prior biliary sphincterotomy and scheduled for repeat biliary therapy without an anticipated pancreatogram
• or anticipated inability to follow our protocol

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

Department of Gastrointestinal Endoscopy and Department of Gastroenterology of the Specialties Hospital of the Western Medical Center of the Mexican Institute of Social Security.

Guadalajara, Jalisco, Mexico

Location

Related Publications (1)

• Andrade-Davila VF, Chavez-Tostado M, Davalos-Cobian C, Garcia-Correa J, Montano-Loza A, Fuentes-Orozco C, Macias-Amezcua MD, Garcia-Renteria J, Rendon-Felix J, Cortes-Lares JA, Ambriz-Gonzalez G, Cortes-Flores AO, Alvarez-Villasenor Adel S, Gonzalez-Ojeda A. Rectal indomethacin versus placebo to reduce the incidence of pancreatitis after endoscopic retrograde cholangiopancreatography: results of a controlled clinical trial. BMC Gastroenterol. 2015 Jul 21;15:85. doi: 10.1186/s12876-015-0314-2.

  PMID: 26195123 DERIVED

MeSH Terms

Interventions

Indomethacin

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• González-Ojeda Alejandro, Ph.D., M.D.

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD. MD

Study Record Dates

• First Submitted: April 7, 2014
• First Posted: April 10, 2014
• Study Start: January 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 24, 2015

Record last verified: 2015-03

Locations

ME (1)