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Anastomotic Techniques in Pancreaticoduodenectomy (PG/PJ)

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ClinicalTrials.gov Identifier: NCT00855985
Recruitment Status : Unknown
Verified September 2011 by Dr H Ramesh, Lakeshore Hospital.
Recruitment status was:  Active, not recruiting
First Posted : March 5, 2009
Last Update Posted : September 27, 2011
Sponsor:
Information provided by (Responsible Party):
Dr H Ramesh, Lakeshore Hospital

Study Description
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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


Condition or disease Intervention/treatment Phase
Pancreatic Cancer Pancreatic Fistula Procedure: type of anastomosis after pancreaticoduodenectomy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 312 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of Pancreaticogastrostomy Versus Pancreaticojejunostomy in Reconstruction After Pancreaticoduodenectomy for Cancer
Study Start Date : July 2004
Estimated Primary Completion Date : October 2011
Estimated Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas
U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. pancreatic fistula rate [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. mortality [ Time Frame: 90 days ]
  2. Hospital stay [ Time Frame: 90 days ]
  3. need for postoperative intervention [ Time Frame: 90 days ]
  4. major complication [ Time Frame: 90 days ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Dr H Ramesh, Director of Surgical Gastroenterology, Lakeshore Hospital
ClinicalTrials.gov Identifier: NCT00855985     History of Changes
Other Study ID Numbers: 001
First Posted: March 5, 2009    Key Record Dates
Last Update Posted: September 27, 2011
Last Verified: September 2011

Keywords provided by Dr H Ramesh, Lakeshore Hospital:
Pancreatic anastomosis
Whipple operation

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