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

ERCP Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04255095
• Other study ID #: ERCP-0001
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: June 1, 2021

Study information

• Verified date: January 2020
• Source: Renmin Hospital of Wuhan University
• Contact: Qiong Gong, Doctor
• Phone: +8618086496360
• Email: gongq2019[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• ERCP
• Pancreatitis

Intervention

Procedure:
• experiment
Treatment was randomly selected according to preoperative grouping. After ERCP, naso-pancreatic drainage was chosen as treatment?
• control
Treatment was randomly selected according to preoperative grouping. After ERCP, nasobiliary drainage was chosen as treatment?

Locations

Country	Name	City	State
China	Renmin Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Renmin Hospital of Wuhan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rehabilitation	time from ERCP to ischarge	2 months
Primary	complication rate	Pancreatitis aggravation, hemorrhage,fistula	1 months
Secondary	LOS(length of stay)	time from operation to discharge	postoperative period(1 month )
Secondary	death rate	Mortality from the disease	postoperative period(1 month )