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
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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 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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Pancreaticojejunostomy for reconstruction after pancreaticoduodenectomy
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Procedure: type of anastomosis after pancreaticoduodenectomy
pancreaticojejunostomy (arm 1) versus pancreaticogastrostomy (arm 2)for reconstruction of the pancreatic remnant after pancreaticoduodenectomy
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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
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- pancreatic fistula rate [ Time Frame: 30 days ]
- 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 ]

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Ages Eligible for Study: | 20 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
India | |
Lakeshore Hospital & Research Center | |
Cochin, Kerala, India, 682024 |
Principal Investigator: | Hariharan Ramesh, MS MCh | Lakeshore Hospital |
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 |