The Efficacy of Pancreatic Duct Stenting With Rectal Indomethacin in Preventing Post-ERCP Pancreatitis

NCT03643900 | Completed

• 1 other identifier: 2018053013
• Study Type: interventional
• Target: 618
• Locations: 1 country
• Sites: 1

Brief Summary

With the development of endoscopic technology, ERCP has been widely used in the diagnosis and treatment of pancreatobiliary diseases, and has become the first treatment for most of the biliary and pancreatic diseases. Postoperative ERCP pancreatitis (PEP) is the most common and serious complication after ERCP. The purpose of this study was to explore methods for preventing postoperative pancreatitis.

1. 1.Participants: Patients with high-risk factors associated with PEP were included in the no-obvious patients who underwent therapeutic ERCP in our hospital from June 2018 to December 2019.
2. 2.Research methods: Patients were randomly divided into indometacin suppositories, indomethacin suppositories and pancreatic stents.
3. 3.Statistical methods: SPSS 13.0 statistical software was used. The measurement data was expressed as x± s, and t-test or non-parametric test was used. Chi-square test was used for count data.

Conditions

Post-ERCP Pancreatitis; Pancreatitis, Acute Necrotizing

Outcome Measures

Primary Outcomes (1)

• the incidence of PEP

  the rate of patients with PEP

  24 hours

Secondary Outcomes (2)

• CT severity index

  72 hours

• the incidence of severe PEP

  7 days

Study Arms (2)

indomethacin with stenting group

EXPERIMENTAL

Pancreatic duct stenting and rectal indomethacin 100mg at preoperative 30min in 100 patients

Device: pancreatic duct stenting; Drug: rectal indomethacin

indomethacin group

ACTIVE COMPARATOR

Rectal indomethacin 100mg at preoperative 30min in 100 patients

Drug: rectal indomethacin

Interventions

pancreatic duct stenting DEVICE

Place the pancreatic duct stent

Also known as: pancreatic stent

indomethacin with stenting group

rectal indomethacin DRUG

rectal indomethacin 100mg at preoperative 30min

Also known as: Indomethacin Suppositories

indomethacin group; indomethacin with stenting group

Eligibility Criteria

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

You may qualify if:

• Age over 18 years old,gender is not limited; Preoperative blood amylase is normal; PEP risk factors during surgery:difficulty in intubation,needle knife incision,intraoperative intubation into the pancreatic duct more than 3 times,the contrast agent in the pancreatic duct is filled; The research procedure is willing to be followed and the informed consent is signed.

You may not qualify if:

• Myocardial infarction occurred within 3 months; Insufficiency of renal function; Conventional gastrectomy; Preoperative state of shock,such as hypotension(systolic blood pressure less than 90mmHg); Pregnancy and lactation; Allergic to NSAIDs drugs; Partially or completely restricted in the ability to exercise consciousness,without self-determination ability; Are participating in other clinical observation trials or have participated in other clinical trials within 60 days; Cases considered unsuitable by the investigator.

Sponsors & Collaborators

• First People's Hospital of Hangzhou: lead

Study Sites (1)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 31006, China

Location

MeSH Terms

Conditions

Pancreatitis, Acute Necrotizing

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases

Study Officials

• Jianfeng Yang

  First People's Hospital of Hangzhou

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: June 24, 2018
• First Posted: August 23, 2018
• Study Start: August 8, 2018
• Primary Completion: August 18, 2021
• Study Completion: August 18, 2021
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)