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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Application of Negative Pressure Suction in Nasopancreatic Duct in Patients With Severe Biliary Pancreatitis

Conditions
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ERCP

Intervention / Treatment
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* Procedure: experiment
* Procedure: control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nasobiliary drainage<br> | Procedure: control<br>* Treatment was randomly selected according to preoperative grouping. After ERCP, nasobiliary drainage was chosen as treatment。<br>* Other names: naso-biliary drinage;|
| Experimental: Naso-pancreatic drainage(negative pressure)<br> | Procedure: experiment<br>* Treatment was randomly selected according to preoperative grouping. After ERCP, naso-pancreatic drainage was chosen as treatment。<br>* Other names: Naso-pancreatic duct negative pressure attraction;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rehabilitation | time from ERCP to ischarge | 2 months | 
| complication rate | Pancreatitis aggravation， hemorrhage，fistula | 1 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LOS(length of stay) | time from operation to discharge | postoperative period（1 month ） | 
| death rate | Mortality from the disease | postoperative period（1 month ） | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatic duct negative-pressure suction