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

NCT ID: NCT03643900

Last Updated: 2021-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 618 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-08
• Study Completion Date: 2021-08-18

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. 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. Research methods: Patients were randomly divided into indometacin suppositories, indomethacin suppositories and pancreatic stents.

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.

Detailed Description

Patients with high risk factors for PEP who will be examined and diagnosed by ERCP at 2018.06-2019.12 in the First People's Hospital of Hangzhou are randomly divided into two groups.

2. Record the relevant indicators of each group of patients: 1 before and after surgery 3, 12, 24 h serum amylase changes 2 patients with abdominal pain, abdominal distension, fever, vomiting and abdominal signs of change; 3 hospital days; 4 CT severity index (CT severity Index, CTSI score: Balthazar 5 scores were scored as 0 to 4 points; according to the scope of necrosis was divided into no, <33%, 33% to 50%,> 50%, respectively rated as 0, 2, 4 and 6 points. Addition of the two scores is the CTSI score. 5 According to the diagnostic criteria for postoperative ERCP pancreatitis, PEP will be diagnosed in patients with persistent abdominal pain within 24 hours after ERCP and blood amylase increase by more than 3 times the normal value. Observed 2 groups of post-ERCP pancreatitis, severe pancreatitis and adverse events Incidence.

3. Analyze and compare the above indicators and observe the effect of the two methods on the reduction of blood amylase level and incidence of pancreatitis. It is clear that rectal administration of preoperative indomethacin suppository has the same protection against PEP as pancreatic stenting effect.

Conditions

Post-ERCP Pancreatitis; Pancreatitis, Acute Necrotizing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

indomethacin with stenting group

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

Group Type: EXPERIMENTAL

pancreatic duct stenting

Intervention Type: DEVICE

Place the pancreatic duct stent

rectal indomethacin

Intervention Type: DRUG

rectal indomethacin 100mg at preoperative 30min

indomethacin group

Rectal indomethacin 100mg at preoperative 30min in 100 patients

Group Type: ACTIVE_COMPARATOR

rectal indomethacin

Intervention Type: DRUG

rectal indomethacin 100mg at preoperative 30min

Interventions

pancreatic duct stenting

Place the pancreatic duct stent

Intervention Type: DEVICE

rectal indomethacin

rectal indomethacin 100mg at preoperative 30min

Intervention Type: DRUG

Other Intervention Names

pancreatic stent; Indomethacin Suppositories

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First People's Hospital of Hangzhou

OTHER

Sponsor Role: lead

Responsible Party

Jianfeng Yang

chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jianfeng Yang

Role: PRINCIPAL_INVESTIGATOR

First People's Hospital of Hangzhou

Locations

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

2018053013

Identifier Type: -

Identifier Source: org_study_id