Clinical trial NCT02797067: Rectal Indomethacin to Prevent Post ESWL-pancreatitis
Official title: Rectally Administered Indomethacin to Prevent Post-ESWL-pancreatitis (RIPEP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pancreatitis
Keywords: Extracorporeal Shock Wave lithotripsy(ESWL)
Prophylaxis
Indomethacin
Chronic pancreatitis
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2016-06-13
Enrollment: 1370
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: the Incidence of Post-ESWL Pancreatitis
timeFrame: up to 1 months
Secondary outcomes:
measure: the Incidence and Severity of Asymptomatic Hyperamylasemia and Other Post-ESWL Complications
timeFrame: up to 1 months
measure: the Severity of Post-ESWL Pancreatitis Measured as Consensus Definitions for the Major Complications of ERCP（Endoscopic Retrograde Cholangiopancreatography ）
timeFrame: up to 1 months
Other outcomes:
measure: 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）.
timeFrame: up to 1 months
Locations:
city: Shanghai
country: China
facility: Shanghai Changhai Hospital
Study officials:
affiliation: Changhai Hospital
name: Zhuan Liao, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.