Anastomotic Techniques in Pancreaticoduodenectomy (PG/PJ)

September 24, 2011 updated by: Dr H Ramesh, Lakeshore Hospital

A Randomised Controlled Trial of Pancreaticogastrostomy Versus Pancreaticojejunostomy in Reconstruction After Pancreaticoduodenectomy for Cancer

There are two principal ways of draining the remnant of the pancreas back into the intestine after removal of the head of the pancreas for cancer. This can be performed either to the jejunum or to the stomach. The aim of this study is to randomly allocate consenting patients to one of the two arms to study whether the leak rates from the anastomosis and the outcomes after the surgery are affected.

Previous papers have shown similar results in both groups although non randomized data suggested that the Pancreaticogastrostomy (drainage into the stomach) may be superior

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

312

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

  • India
    • Kerala
      • Cochin, Kerala, India, 682024
        • Lakeshore Hospital & Research Center

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

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Pancreaticoduodenectomy for adenocarcinoma of the pancreatic head
  2. resectable tumour

Exclusion Criteria:

  1. chronic pancreatitis/benign tumours-
  2. tumours extending into the body of the pancreas
  3. tumours with metastasis beyond regional lymph nodes
  4. requirement for sub total pancreatectomy
  5. prolonged hypotension - < 80 mm of hg for more than 30 min

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Pancreaticojejunostomy for reconstruction after pancreaticoduodenectomy
Procedure: type of anastomosis after pancreaticoduodenectomy
pancreaticojejunostomy (arm 1) versus pancreaticogastrostomy (arm 2)for reconstruction of the pancreatic remnant after pancreaticoduodenectomy
Active Comparator: 2
Pancreaticogastrostomy for reconstruction after pancreaticoduodenectomy
Procedure: type of anastomosis after pancreaticoduodenectomy
pancreaticojejunostomy (arm 1) versus pancreaticogastrostomy (arm 2)for reconstruction of the pancreatic remnant after pancreaticoduodenectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pancreatic fistula rate
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
mortality
Time Frame: 90 days
90 days
Hospital stay
Time Frame: 90 days
90 days
need for postoperative intervention
Time Frame: 90 days
90 days
major complication
Time Frame: 90 days
90 days

Collaborators and Investigators

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

Sponsor

Lakeshore Hospital

Investigators

  • Principal Investigator: Hariharan Ramesh, MS MCh, Lakeshore 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

July 1, 2004

Primary Completion (Anticipated)

October 1, 2011

Study Completion (Anticipated)

October 1, 2011

Study Registration Dates

First Submitted

March 4, 2009

First Submitted That Met QC Criteria

March 4, 2009

First Posted (Estimate)

March 5, 2009

Study Record Updates

Last Update Posted (Estimate)

September 27, 2011

Last Update Submitted That Met QC Criteria

September 24, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 (Buy Pharma Ecza Deposu San. Tic. Ltd.)

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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