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

History of Changes

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:

MedlinePlus related topics: Fistulas Plastic and Cosmetic Surgery

Drug Information available for: Sodium polystyrene sulfonate

Genetic and Rare Diseases Information Center resources: Pancreatic Cancer

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 ]


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:

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 February 26, 2015

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