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Completed

NCT Number: NCT02797067

Rectal Indomethacin to Prevent Post ESWL-pancreatitis

The purpose of the study is to determine whether rectal indomethacin reduces the incidence of post-ESWL pancreatitis.

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Key information

Conditions

Pancreatitis Chronic Disease Digestive System Diseases Disease Attributes Pancreatic Diseases Pancreatitis, Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shanghai Changhai Hospital

Shanghai, China

About this study

It is a prospective, double-blind, randomized controlled trial. Patients with painful chronic pancreatitis and pancreatic stones (> 5 mm in diameter) who are treated with ESWL at Changhai Hospital will be randomly allocated to indomethacin or placebo therapy before the procedure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • any patient with chronic pancreatitis and pancreatic stones (> 5 mm in diameter) undergoing P-ESWL
  • at least 18 years old
  • provides informed consent

Exclusion criteria

  • readmitted to the hospital during the enrollment of the study
  • contraindications to ESWL
  • suspected or established malignancy
  • pancreatic ascites
  • receiving NSAIDs within 7 days
  • contraindication to NSAIDs (including gastrointestinal hemorrhage within 4 weeks or renal dysfunction with serum creatinine >120 μmol/L)
  • presence of coagulopathy or received anticoagulation therapy within 3 days
  • acute pancreatitis within 3 days
  • known active cardiovascular or cerebrovascular disease
  • pregnant or breastfeeding women
  • without a rectum (ie, status post-total proctocolectomy)

Treatment and study plan

Indomethacin suppository

Drug

100mg rectal indomethacin 30min before ESWL

Glycerin Suppository

Drug

30min before ESWL

Primary outcomes

  1. the Incidence of Post-ESWL Pancreatitis

    Time frame: up to 1 months

    Patients were identified as post-ESWL pancreatitis if meeting two out of three criteria: pain consistent with acute pancreatitis; amylase or lipase>3 times normal limit; characteristic findings on imaging, in according to the Revised Atlanta International consensus.

Secondary outcomes

  1. the Incidence and Severity of Asymptomatic Hyperamylasemia and Other Post-ESWL Complications

    Time frame: up to 1 months

    Asymptomatic hyperamylasemia was defined as an increase in serum amylase compared with pre-ESWL levels and beyond the upper limit of the normal range but showing no related symptoms. Serum amylase will be measured in all study patients at 3 and 24 hours after the procedure and subsequently at clinical discretion.

    Other post-ESWL complications including bleeding, infection, steinstrasse and perforation.

    Bleeding is related to clinical evidence，the level of hemoglobin ( measured at 24 hours after the procedure and at clinical discretion) and treatments.

    Infection is related to temperature and treatment. Steinstrasse is related to abdominal pain degree and the combination of other complications.

    Perforation is related to treatment.

  2. the Severity of Post-ESWL Pancreatitis Measured as Consensus Definitions for the Major Complications of ERCP（Endoscopic Retrograde Cholangiopancreatography ）

    Time frame: up to 1 months

    Post-ESWL complications are also stratified as mild, moderate and severe depending mainly on the length of hospitalization and the need for invasive treatment.

Other outcomes

  1. Relative Risks in the Subgroup of Potential Risk Factors for Post -ESWL Pancreatitis Will be Assessed by SPSS（Statistical Product and Service Solutions，a Statistical Software）.

    Time frame: up to 1 months

    Potential risk factors including sex, steatorrhea, pancreas divisum, frequent attack of acute pancreatitis (≥ 1/year), diabetes, CBD（common bile duct） stenosis, alcohol consumption, multiple stones, position (the 30°-right supine position) and shock wave frequency ≥100/min.These will be assess to determine whether the treatment effect differ in these pre-specified factors.

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

Rectally Administered Indomethacin to Prevent Post-ESWL-pancreatitis (RIPEP)

Acronym: RIPEP

Important dates

Study start
2016
Primary completion
2019
Study completion
2021
First posted
Jun 13, 2016
Registry last updated
May 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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