Trial of Aggressive Hydration Versus Rectal Indomethacin for Prevention of Post-ERCP Pancreatitis

NCT03629600 | Completed Phase 2

• 1 other identifier: IEC/2016/396
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

Brief Summary

Endoscopic Retrograde Cholangiopancreatography (ERCP) is a commonly performed endoscopic procedure used to treat pancreato-biliary pathology. Acute pancreatitis or post-ERCP pancreatitis (PEP), is the most common major complication of ERCP, which is reported to occur in 2-10% of patients overall (ranging from 2-4% in low risk patients up to 8-40% in high-risk patients). Hydration is a mainstay of treatment for acute pancreatitis, independent of etiology. Aggressive hydration has also been shown to decrease incidence of PEP. Rectal NSAIDs, including Indomethacin, has a proven role in prevention of PEP. Though both aggressive hydration and rectal indomethacin are efficacious in preventing PEP, there is no head to head trial comparing the efficacy of these two therapeutic modalities. Thus, the aim is to determine whether aggressive intravenous peri-procedural hydration or high dose rectal indomethacin immediately after ERCP decrease the incidence of PEP. The investigator's hypothesis is that prophylactic treatment with aggressive intravenous hydration is not inferior to rectal indomethacin in preventing PEP.

Conditions

Post-ERCP Acute Pancreatitis

Outcome Measures

Primary Outcomes (1)

• Post-ERCP Acute Pancreatitis

  The primary endpoint is development of post-ERCP pancreatitis (PEP, a categorical variable) which will be defined as presence of increased abdominal pain and a serum amylase level three times the upper limit of normal (3xULN). Increased pain will be defined as an increase in the visual analog pain score compared to the value immediately prior to ERCP

  24 hours

Secondary Outcomes (3)

• Clinical volume overload

  24 hours

• Serum Amylase three times the upper limit of normal

  8 hours

• Post-ERCP pain abdomen: VAS

  24 hours

Other Outcomes (1)

• Death

  7 days

Study Arms (2)

Aggressive Hydration

EXPERIMENTAL

Patients randomized to the aggressive intravenous hydration group received Lactated Ringers solution (LR) \[COMPOUND SODIUM LACTATE INJECTION I.P.,INVEN PHARMACEUTICALS PVT.LTD,MP,INDIA\] intravenously (IV) at 3 mL/kg/hr during the ERCP, a 20cc/kg IV bolus immediately afterward, and then at 3 mL/kg/hr for 8 hours following the procedure.

Drug: Lactated Ringer

Rectal Indomethacin

ACTIVE COMPARATOR

Patients randomised to Rectal Indomethacin were administered a suppository of 100 mg of indomethacin \[Indomethacin Suppository 100 Mg B.P, GALEN PHARMACEUTICAL LTD, GUJRAT, INDIA\] just after the completion of ERCP procedure.

Drug: Rectal Form Indometacin

Interventions

Lactated Ringer DRUG

High-volume Lactated Ringer Solution

Also known as: COMPOUND SODIUM LACTATE INJECTION I.P., INVEN PHARMACEUTICALS PVT.LTD, MP, INDIA

Aggressive Hydration

Rectal Form Indometacin DRUG

Post-ERCP rectal administration of 100 MG Indomethacin

Also known as: INDOMETHACIN SUPPOSITORY 100 Mg B.P, GALEN PHARMACEUTICAL LTD, GUJRAT, INDIA

Rectal Indomethacin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients aged 18 to 70 years undegoingt ERCP for the first time
• Patients undergoing ERCP for standard clinical indications

You may not qualify if:

• Ongoing acute pancreatitis
• Known chronic calcific pancreatitis
• Pancreatic head mass
• Any malignancy
• Standard contraindications to ERCP
• Unwillingness or inability to consent for the study
• Ongoing hypotension including those with sepsis
• Cardiac insufficiency (CI, \>NYHA Class II heart failure)
• Renal insufficiency (RI, creatinine clearance \<40mL/min)
• Severe liver dysfunction (albumin \< 3mg/dL)
• Respiratory insufficiency (defined as oxygen saturation \< 90%)
• Greater than 70 years of age
• Pregnancy
• Breastfeeding mother
• Allergy/hypersensitivity to aspirin or NSAIDs

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

IPGIMER

Kolkata, West Bengal, 700020, India

Location

Related Publications (1)

• Guha P, Patra PS, Misra D, Ahammed SM, Sarkar R, Dhali GK, Ray S, Das K. An Open-Label Randomized Controlled Trial Comparing Effectiveness of Aggressive Hydration Versus High-dose Rectal Indomethacin in the Prevention of Postendoscopic Retrograde Cholangiopancreatographic Pancreatitis (AHRI-PEP). J Clin Gastroenterol. 2023 May-Jun 01;57(5):524-530. doi: 10.1097/MCG.0000000000001712. Epub 2022 Apr 21.

  PMID: 35470300 DERIVED

MeSH Terms

Interventions

Ringer's Lactate

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Kshaunish Das, MD, DM

  Professor, Division of Gastroenterology, SDLD, IPGMER

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Division of Gastroenterology, SDLD

Model Details: Prospective randomized open-label parallel-group non-inferiority controlled clinical trial

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 14, 2018
• Study Start: October 15, 2017
• Primary Completion: February 15, 2018
• Study Completion: May 31, 2018
• Last Updated: August 16, 2018

Record last verified: 2018-08

Locations

IN (1)