Pancreatic Stent for Distal Pancreatectomy

October 16, 2023 updated by: Weishen WANG, Ruijin Hospital

A Prospective Randomized Controlled Study Comparing Outcomes of Distal Pancreatectomy With or Without Pancreatic Stent

The purpose of this study is to compare outcomes of patients undergoing distal pancreatectomy with or without pancreatic stent

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Shanghai Ruijin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients undergoing distal pancreatectomy
  2. Signed the informed consents

Exclusion Criteria:

  1. Recurrence patients
  2. pre-operative anti-cancer treatment
  3. patients with contraindication(hepatic/ respiratory/ renal dysfunction, etc )
  4. AJCC stage IV
  5. pre operative oddi'ssphincter incision
  6. operation non radical
  7. pancreatic stent not at place

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Distal Pancreatectomy without pancreatic stent
Experimental: Distal Pancreatectomy with pancreatic stent
pancreatic stent will be placed in the main pancreatic duct during the operation
Device: Pancreatic stent: PSOF COOK®
After removing the distal pancreas, PSOF COOK will be place in the main pancreatic duct

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all-cause mortality / complications
Time Frame: Hospitalization 30days（duration of hospital stay)
mortality, pancreatic fistula, Biliary fistula，bleeding， etc
Hospitalization 30days（duration of hospital stay)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
all-cause mortality / complications
Time Frame: 30 days after operation
mortality, pancreatic fistula, Biliary fistula，bleeding， etc
30 days after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2017

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

October 6, 2017

First Submitted That Met QC Criteria

October 17, 2017

First Posted (Actual)

October 19, 2017

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 16, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HBP-RCT-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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