Rectal Indomethacin to Prevent Post ESWL-pancreatitis

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Brief Title

Rectal Indomethacin to Prevent Post ESWL-pancreatitis

Official Title

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

Brief Summary

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

Detailed Description

      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.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

the incidence of post-ESWL pancreatitis

Secondary Outcome

 the incidence and severity of asymptomatic hyperamylasemia and other post-ESWL complications

Condition

Pancreatitis

Intervention

indomethacin suppository

Study Arms / Comparison Groups

 Indomethacin
Description:  Subjects will be randomized to receive a 100-mg indomethacin suppository 30 min before ESWL.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

1428

Start Date

May 2016

Completion Date

December 2020

Primary Completion Date

November 2020

Eligibility Criteria

        Inclusion Criteria:

          -  any patient with painful chronic pancreatitis and pancreatic stones (> 5 mm in
             diameter) undergoing P-ESWL

          -  at least 18 years old

          -  provides informed consent

        Exclusion Criteria:

          -  no pain history during course of chronic pancreatitis

          -  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)
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Zhuan Liao, MD, , [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT02797067

Organization ID

ESWL-pancreatitis


Responsible Party

Principal Investigator

Study Sponsor

Changhai Hospital


Study Sponsor

Zhuan Liao, MD, Principal Investigator, Changhai Hospital


Verification Date

June 2020