Early Intervention of High Tension in the Pancreatic Duct on the Outcome of Severe Biliary Pancreatitis

Not Applicable

• Conditions: ERCP
• Interventions: Procedure: control; Procedure: experiment

• Registration Number: NCT04255095
• Lead Sponsor: Renmin Hospital of Wuhan University

Brief Summary

The investigators hypothesized that naso-pancreatic duct suction could benefit for patients with severe biliary pancreatitis undergoing ERCP. So, the investigators designed this experiment to verify it.

Detailed Description

This project intends to conduct treatment based on different interventions for enrolled subjects according to international and domestic standardized treatment procedures, including 1.ERCP stone extraction, duodenal papillary pressure measurement, bile duct pressure measurement, and nasal bile duct placement; 2.ERCP+ duodenal papillary pressure measurement, biliopancreatic duct pressure measurement + nasopancreatic duct + determine whether nasopancreatic duct negative pressure attraction.Compare the advantages of two different treatment methods.This paper attempts to explore new treatment methods that are more conducive to the rehabilitation of patients and provides an important preliminary research basis for the future clinical application of standardized treatment.

Patients from the people's hospital of Wuhan university were recruited and selected into groups. The incidence, recurrence rate, operation time and hospital stay of the two independent samples will be compared.

Study Timeline

• Study Start: 2019-10-01
• Status Verified: 2020-01
• Study First Submitted: 2020-01-30
• Study First Submitted QC: 2020-02-02
• Last Update Submitted: 2020-02-02
• Study First Posted: 2020-02-05
• Last Update Posted: 2020-02-05
• Primary Completion: 2021-04-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Ages 16 to 75. Apach-ii score of patients diagnosed with pancreatitis was greater than 8 points.

Liver function can be damaged. Elevated indicators of pancreatitis (hematuria amylase, lipase). Identify patients with biliary tract infection or obstruction.

Exclusion Criteria

Older than 75 or younger than 16. The duration of admission was more than 72 hours. Gastrointestinal obstruction endoscopy cannot be operated. Patients with duodenoscopy contraindications.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nasobiliary drainage	control	-
Naso-pancreatic drainage(negative pressure)	experiment	-

Primary Outcome Measures

Name	Time	Method
Rehabilitation	2 months	time from ERCP to ischarge
complication rate	1 months	Pancreatitis aggravation， hemorrhage，fistula

Secondary Outcome Measures

Name	Time	Method
death rate	postoperative period（1 month ）	Mortality from the disease
LOS(length of stay)	postoperative period（1 month ）	time from operation to discharge

Trial Locations

Locations (1)

Renmin Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China