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Anastomotic Techniques in Pancreaticoduodenectomy (PG/PJ)

Primary Purpose

Pancreatic Cancer, Pancreatic Fistula

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
type of anastomosis after pancreaticoduodenectomy
Sponsored by
Lakeshore Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring Pancreatic anastomosis, Whipple operation

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lakeshore Hospital & Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Pancreaticojejunostomy for reconstruction after pancreaticoduodenectomy

Pancreaticogastrostomy for reconstruction after pancreaticoduodenectomy

Outcomes

Primary Outcome Measures

pancreatic fistula rate

Secondary Outcome Measures

mortality
Hospital stay
need for postoperative intervention
major complication

Full Information

First Posted
March 4, 2009
Last Updated
September 24, 2011
Sponsor
Lakeshore Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00855985
Brief Title
Anastomotic Techniques in Pancreaticoduodenectomy
Acronym
PG/PJ
Official Title
A Randomised Controlled Trial of Pancreaticogastrostomy Versus Pancreaticojejunostomy in Reconstruction After Pancreaticoduodenectomy for Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Unknown status
Study Start Date
July 2004 (undefined)
Primary Completion Date
October 2011 (Anticipated)
Study Completion Date
October 2011 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lakeshore Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Pancreatic Fistula
Keywords
Pancreatic anastomosis, Whipple operation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
312 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Pancreaticojejunostomy for reconstruction after pancreaticoduodenectomy
Arm Title
2
Arm Type
Active Comparator
Arm Description
Pancreaticogastrostomy for reconstruction after pancreaticoduodenectomy
Intervention Type
Procedure
Intervention Name(s)
type of anastomosis after pancreaticoduodenectomy
Intervention Description
pancreaticojejunostomy (arm 1) versus pancreaticogastrostomy (arm 2)for reconstruction of the pancreatic remnant after pancreaticoduodenectomy
Primary Outcome Measure Information:
Title
pancreatic fistula rate
Time Frame
30 days
Secondary Outcome Measure Information:
Title
mortality
Time Frame
90 days
Title
Hospital stay
Time Frame
90 days
Title
need for postoperative intervention
Time Frame
90 days
Title
major complication
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pancreaticoduodenectomy for adenocarcinoma of the pancreatic head resectable tumour Exclusion Criteria: chronic pancreatitis/benign tumours- tumours extending into the body of the pancreas tumours with metastasis beyond regional lymph nodes requirement for sub total pancreatectomy prolonged hypotension - < 80 mm of hg for more than 30 min
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hariharan Ramesh, MS MCh
Organizational Affiliation
Lakeshore Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lakeshore Hospital & Research Center
City
Cochin
State/Province
Kerala
ZIP/Postal Code
682024
Country
India

12. IPD Sharing Statement

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Anastomotic Techniques in Pancreaticoduodenectomy

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