Anastomotic Techniques in Pancreaticoduodenectomy - Full Text View

Sponsored by:	Lakeshore Hospital
Information provided by:	Lakeshore Hospital
ClinicalTrials.gov Identifier:	NCT00855985

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 Postoperative Pancreatic Fistula	Procedure: type of anastomosis after pancreaticoduodenectomy

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment
Official Title:	A Randomised Controlled Trial of Pancreaticogastrostomy Versus Pancreaticojejunostomy in Reconstruction After Pancreaticoduodenectomy for Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Fistulas Pancreatic Cancer Surgery

U.S. FDA Resources

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 ]

Estimated Enrollment:	196
Study Start Date:	July 2004
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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
2: Active Comparator 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:

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

Contacts and Locations

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

Contacts

Contact: Hariharan Ramesh, MS MCh FRCS FACS	2701992 ext 2036	hramesh@vsnl.com
Contact: Asha S Nair	2701992 ext 2198	ashasn@hotmail.com

Locations

India, Kerala
Lakeshore Hospital & Research Center	Recruiting
Cochin, Kerala, India, 682024
Sub-Investigator: MMS Bedi, MS
Sub-Investigator: MD Gandhi, MS
Principal Investigator: hariharan Ramesh, MS, MCh FACS FRCS

Sponsors and Collaborators

Lakeshore Hospital

Investigators

Principal Investigator:

Hariharan Ramesh, MS MCh FACS FRCS

Lakeshore Hospital

More Information

No publications provided

Responsible Party:	Lakeshore Hospital ( Dr H Ramesh )
Study ID Numbers:	001
Study First Received:	March 4, 2009
Last Updated:	March 4, 2009
ClinicalTrials.gov Identifier:	NCT00855985 History of Changes
Health Authority:	India: ethics committee of Lakeshore Hospital

Keywords provided by Lakeshore Hospital:

Pancreatic anastomosis
Whipple operation

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Digestive System Neoplasms
Digestive System Diseases
Pancreatic Neoplasms
Endocrine System Diseases
Gastrointestinal Neoplasms

Pancreatic Diseases
Endocrinopathy
Pancreatic Fistula
Endocrine Gland Neoplasms
Fistula

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Pancreatic Neoplasms

Digestive System Fistula
Endocrine System Diseases
Pancreatic Diseases
Pancreatic Fistula
Endocrine Gland Neoplasms
Fistula

ClinicalTrials.gov processed this record on September 11, 2009