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

NCT ID: NCT04255095

Last Updated: 2020-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2021-06-01

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.

Conditions

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ERCP

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nasobiliary drainage

Group Type ACTIVE_COMPARATOR

control

Intervention Type PROCEDURE

Treatment was randomly selected according to preoperative grouping. After ERCP, nasobiliary drainage was chosen as treatment。

Naso-pancreatic drainage(negative pressure)

Group Type EXPERIMENTAL

experiment

Intervention Type PROCEDURE

Treatment was randomly selected according to preoperative grouping. After ERCP, naso-pancreatic drainage was chosen as treatment。

Interventions

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experiment

Treatment was randomly selected according to preoperative grouping. After ERCP, naso-pancreatic drainage was chosen as treatment。

Intervention Type PROCEDURE

control

Treatment was randomly selected according to preoperative grouping. After ERCP, nasobiliary drainage was chosen as treatment。

Intervention Type PROCEDURE

Other Intervention Names

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Naso-pancreatic duct negative pressure attraction naso-biliary drinage

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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Renmin Hospital of Wuhan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qiong Gong, Doctor

Role: CONTACT

+8618086496360

Z'hong'chao Zhu, Doctor

Role: CONTACT

+8613995617151

Facility Contacts

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Qiong Gong, Doctor

Role: primary

+86 18086496360

Other Identifiers

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ERCP-0001

Identifier Type: -

Identifier Source: org_study_id

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