Rectal Indomethacin to Prevent Post ESWL-pancreatitis

NCT02797067 | Completed Phase 4 Results DMC

• 1 other identifier: ESWL-pancreatitis
• Study Type: interventional
• Target: 1,370
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pancreatitis

Keywords

Extracorporeal Shock Wave lithotripsy(ESWL); Prophylaxis; Indomethacin; Chronic pancreatitis

Outcome Measures

Primary Outcomes (1)

• the Incidence of Post-ESWL Pancreatitis

  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.

  up to 1 months

Secondary Outcomes (2)

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

  up to 1 months

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

  up to 1 months

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）.

  up to 1 months

Study Arms (2)

Indomethacin

EXPERIMENTAL

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

Drug: indomethacin suppository

Glycerin

PLACEBO COMPARATOR

Subjects will be randomized to receive either a 100-mg identical-appearing placebo (glycerin suppository) 30 min before ESWL.

Drug: Glycerin Suppository

Interventions

indomethacin suppository DRUG

100mg rectal indomethacin 30min before ESWL

Indomethacin

Glycerin Suppository DRUG

30min before ESWL

Glycerin

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Shanghai Changhai Hospital

Shanghai, China

Location

Related Publications (2)

• Qian YY, Ru N, Chen H, Zou WB, Wu H, Pan J, Li B, Xin L, Guo JY, Tang XY, Hu LH, Jin ZD, Wang D, Du YQ, Wang LW, Li ZS, Liao Z. Rectal indometacin to prevent pancreatitis after extracorporeal shock wave lithotripsy (RIPEP): a single-centre, double-blind, randomised, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2022 Mar;7(3):238-244. doi: 10.1016/S2468-1253(21)00434-9. Epub 2022 Jan 25.

  PMID: 35085482 DERIVED

• Qian YY, Chen H, Tang XY, Jiang X, Qian W, Zou WB, Xin L, Li B, Qi YF, Hu LH, Zou DW, Jin ZD, Wang D, Du YQ, Wang LW, Liu F, Li ZS, Liao Z. Rectally administered indomethacin to prevent post-ESWL-pancreatitis (RIPEP): study protocol for a randomized controlled trial. Trials. 2017 Nov 2;18(1):513. doi: 10.1186/s13063-017-2250-7.

  PMID: 29096689 DERIVED

MeSH Terms

Conditions

Pancreatitis; Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Yangyang Qian
• Organization: Changhai Hospital

919835863@qq.com

13818040017

Study Officials

• Zhuan Liao, MD

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 29, 2016
• First Posted: June 13, 2016
• Study Start: May 31, 2016
• Primary Completion: July 1, 2019
• Study Completion: August 1, 2021
• Last Updated: May 26, 2022
• Results First Posted: May 26, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)