Anastomotic Techniques in Pancreaticoduodenectomy (PG/PJ)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2011 by Dr H Ramesh, Lakeshore Hospital.
Recruitment status was: Active, not recruiting
Recruitment status was: Active, not recruiting
Sponsor:
Lakeshore Hospital
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
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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 (Participant) 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
Drug Information available for:
Sodium polystyrene sulfonate
U.S. FDA Resources
Further study details as provided by Dr H Ramesh, Lakeshore Hospital:
Primary Outcome Measures:
- pancreatic fistula rate [ Time Frame: 30 days ]
Secondary Outcome Measures:
- mortality [ Time Frame: 90 days ]
- Hospital stay [ Time Frame: 90 days ]
- need for postoperative intervention [ Time Frame: 90 days ]
- major complication [ Time Frame: 90 days ]
| 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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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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
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
| 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 |
Keywords provided by Dr H Ramesh, Lakeshore Hospital:
|
Pancreatic anastomosis Whipple operation |
Additional relevant MeSH terms:
|
Digestive System Diseases Pancreatic Diseases Endocrine System Diseases Pathological Conditions, Anatomical Pancreatic Neoplasms Fistula |
Pancreatic Fistula Digestive System Neoplasms Neoplasms by Site Neoplasms Endocrine Gland Neoplasms Digestive System Fistula |
ClinicalTrials.gov processed this record on May 25, 2017