Anastomotic Techniques in Pancreaticoduodenectomy (PG/PJ)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Lakeshore Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Dr H Ramesh, Lakeshore Hospital
ClinicalTrials.gov Identifier:
NCT00855985
First received: March 4, 2009
Last updated: September 24, 2011
Last verified: September 2011
  Purpose

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


Condition Intervention
Pancreatic Cancer
Pancreatic Fistula
Procedure: type of anastomosis after pancreaticoduodenectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of Pancreaticogastrostomy Versus Pancreaticojejunostomy in Reconstruction After Pancreaticoduodenectomy for Cancer

Resource links provided by NLM:


Further study details as provided by Lakeshore Hospital:

Primary Outcome Measures:
  • pancreatic fistula rate [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • mortality [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • Hospital stay [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • need for postoperative intervention [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • major complication [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Enrollment: 312
Study Start Date: July 2004
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00855985

Locations
India
Lakeshore Hospital & Research Center
Cochin, Kerala, India, 682024
Sponsors and Collaborators
Lakeshore Hospital
Investigators
Principal Investigator: Hariharan Ramesh, MS MCh Lakeshore Hospital
  More Information

No publications provided

Responsible Party: Dr H Ramesh, Director of Surgical Gastroenterology, Lakeshore Hospital
ClinicalTrials.gov Identifier: NCT00855985     History of Changes
Other Study ID Numbers: 001
Study First Received: March 4, 2009
Last Updated: September 24, 2011
Health Authority: India: ethics committee of Lakeshore Hospital

Keywords provided by Lakeshore Hospital:
Pancreatic anastomosis
Whipple operation

Additional relevant MeSH terms:
Digestive System Diseases
Endocrine System Diseases
Pancreatic Diseases
Pathological Conditions, Anatomical
Pancreatic Fistula
Pancreatic Neoplasms
Digestive System Fistula
Digestive System Neoplasms
Endocrine Gland Neoplasms
Fistula
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 29, 2014