Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy

January 25, 2017 updated by: TingBo Liang

Randomised Controlled Trail of Duct-to-mucosa Versus Invagination for Pancreaticojejunostomy After Pancreaticoduodenectomy

The purpose of this study is to determine whether duct-to-mucosa is better than invagination in pancreaticojejunostomy after pancreaticoduodenectomy. This single-centre, open, randomized controlled trail is conducted following ISGPF criteria for pancreatic fistula (PF). The duration of the study is supposed to start from Jan 5th 2012 and last to Dec 2014, until 100 or more cases are accessible. Patients diagnosed with pancreatic cancer, peri-ampullar carcinoma or other benign or malignant diseases which need to operate pancreaticoduodenectomy will be included. Main outcomes are pancreatic fistula rate, mortality, morbidity, reoperation and hospital stay. The investigators assumption that duct-to-mucosa is better than invagination.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

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 Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • the Second Affiliated Hospital, School of Medicine, Zhejiang Universtiy
        • Contact:

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients diagnosed with pancreatic cancer or other diseases which need pancreaticoduodenectomy and pancreaticojejunostomy
  • 18 to 80 y/o
  • Operation-tolerated
  • Informed consent

Exclusion Criteria:

  • History of gastrointestinal operation
  • Pancreaticoduodenectomy is given up during operation
  • Pancreatic duct is difficult to locate
  • Patients require to exit from the study anytime

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: duct-to-mucosa
duct-to-mucosa technique is used for pancreaticojejunostomy after pancreaticoduodenectomy
Procedure: duct-to-mucosa
Device: Internal stent
Internal stent may be used during pancreaticojejunostomy according to the situation of pancreatic duct and experience of the surgeon.
Active Comparator: invagination
invagination technique is used for pancreaticojejunostomy after pancreaticoduodenectomy
Device: Internal stent
Internal stent may be used during pancreaticojejunostomy according to the situation of pancreatic duct and experience of the surgeon.
Procedure: invagination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pancreatic fistula
Time Frame: From date of operation until the date of dischage or date of death from any cause, whichever came first,, assessed up to 200 days
The determine of pancreatic fistula follows the International Study Group on Pancreatic Fistulas (ISGPF) criteria.
From date of operation until the date of dischage or date of death from any cause, whichever came first,, assessed up to 200 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 days
30-day or in-hospital mortality: death from any cause within 30 days after operation or any in-hospital death are considered concerned with the type of pancreaticojejunostomy
From date of operation until the date of in-hospital death or death within 30 days after operation, whichever came first, assessed up to 200 days
Morbidity
Time Frame: From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days
any complications after operation will be recorded.
From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days
Reoperation
Time Frame: From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days
Reasons and times of reoperation are recorded. The attending doctor will decided Whether reoperation is needed, according to indications and his experience.
From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days
Hospital stay
Time Frame: From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days
Post-operation hospital stay is assessed.
From date of operation until the date of discharge or date of death from any cause, whichever came first, assessed up to 200 days

Collaborators and Investigators

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

Sponsor

TingBo Liang

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2012

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

September 20, 2012

First Submitted That Met QC Criteria

September 27, 2012

First Posted (Estimate)

September 28, 2012

Study Record Updates

Last Update Posted (Estimate)

January 26, 2017

Last Update Submitted That Met QC Criteria

January 25, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZEH-LL-CX-004-02

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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