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

W

Wuhan University

Status

Unknown

Conditions

ERCP

Treatments

Procedure: control
Procedure: experiment

Study type

Interventional

Funder types

Other

Identifiers

NCT04255095
ERCP-0001

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

16 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

80 participants in 2 patient groups

Nasobiliary drainage
Active Comparator group
Treatment:
Procedure: control
Naso-pancreatic drainage(negative pressure)
Experimental group
Treatment:
Procedure: experiment

Trial contacts and locations

1

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Central trial contact

Z'hong'chao Zhu, Doctor; Qiong Gong, Doctor

Data sourced from clinicaltrials.gov

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