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

Primary Purpose

ERCP

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

experiment

control

About this trial

This is an interventional treatment trial for ERCP focused on measuring Pancreatic duct negative-pressure suction

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Renmin Hospital of Wuhan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Nasobiliary drainage

Naso-pancreatic drainage(negative pressure)

Arm Description

Outcomes

Primary Outcome Measures

Rehabilitation

time from ERCP to ischarge

complication rate

Pancreatitis aggravation， hemorrhage，fistula

Secondary Outcome Measures

LOS(length of stay)

time from operation to discharge

death rate

Mortality from the disease

Full Information

NCT ID

NCT04255095

First Posted

January 30, 2020

Last Updated

February 2, 2020

Sponsor

Renmin Hospital of Wuhan University

1. Study Identification

Unique Protocol Identification Number

NCT04255095

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Unknown status

Study Start Date

October 1, 2019 (Actual)

Primary Completion Date

April 1, 2021 (Anticipated)

Study Completion Date

June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Renmin Hospital of Wuhan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ERCP

Keywords

Pancreatic duct negative-pressure suction

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Nasobiliary drainage

Arm Type

Active Comparator

Arm Title

Naso-pancreatic drainage(negative pressure)

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

experiment

Other Intervention Name(s)

Naso-pancreatic duct negative pressure attraction

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

control

Other Intervention Name(s)

naso-biliary drinage

Intervention Description

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

Primary Outcome Measure Information:

Title

Rehabilitation

Description

time from ERCP to ischarge

Time Frame

2 months

Title

complication rate

Description

Pancreatitis aggravation， hemorrhage，fistula

Time Frame

1 months

Secondary Outcome Measure Information:

Title

LOS(length of stay)

Description

time from operation to discharge

Time Frame

postoperative period（1 month ）

Title

death rate

Description

Mortality from the disease

Time Frame

postoperative period（1 month ）

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Qiong Gong, Doctor

Phone

+8618086496360

gongq2019@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Z'hong'chao Zhu, Doctor

Phone

+8613995617151

Facility Information:

Facility Name

Renmin Hospital of Wuhan University

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Qiong Gong, Doctor

Phone

+86 18086496360

gongq201919@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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