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

Sponsor
Renmin Hospital of Wuhan University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04255095
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
20
Anticipated Duration (Months)
4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: experiment
  • Procedure: control
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Application of Negative Pressure Suction in Nasopancreatic Duct in Patients With Severe Biliary Pancreatitis
Actual Study Start Date :
Oct 1, 2019
Anticipated Primary Completion Date :
Apr 1, 2021
Anticipated Study Completion Date :
Jun 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Nasobiliary drainage

Procedure: control
Treatment was randomly selected according to preoperative grouping. After ERCP, nasobiliary drainage was chosen as treatment。
Other Names:
  • naso-biliary drinage

    		•
    Experimental: Naso-pancreatic drainage(negative pressure)

    Procedure: experiment
    Treatment was randomly selected according to preoperative grouping. After ERCP, naso-pancreatic drainage was chosen as treatment。
    Other Names:
  • Naso-pancreatic duct negative pressure attraction

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Rehabilitation [2 months]

      time from ERCP to ischarge

    2. complication rate [1 months]

      Pancreatitis aggravation， hemorrhage，fistula

    Secondary Outcome Measures

    1. LOS(length of stay) [postoperative period（1 month ）]

      time from operation to discharge

    2. death rate [postoperative period（1 month ）]

      Mortality from the disease

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Renmin Hospital of Wuhan University Wuhan Hubei China 430060

    Sponsors and Collaborators

    • Renmin Hospital of Wuhan University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Renmin Hospital of Wuhan University
    ClinicalTrials.gov Identifier:
    NCT04255095
    Other Study ID Numbers:
    • ERCP-0001
    First Posted:
    Feb 5, 2020
    Last Update Posted:
    Feb 5, 2020
    Last Verified:
    Jan 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Renmin Hospital of Wuhan University
    Pancreatic duct negative-pressure suction
    Additional relevant MeSH terms:
    Pancreatitis

    Study Results

    No Results Posted as of Feb 5, 2020