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2004-07
2011-10
2011-10
312
NCT00855985
Lakeshore Hospital
Lakeshore Hospital
INTERVENTIONAL
Anastomotic Techniques in Pancreaticoduodenectomy
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
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2009-03-04 | N/A | 2011-09-24 |
2009-03-04 | N/A | 2011-09-27 |
2009-03-05 | N/A | 2011-09 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: 1 Pancreaticojejunostomy for reconstruction after pancreaticoduodenectomy | PROCEDURE: type of anastomosis after pancreaticoduodenectomy
|
| ACTIVE_COMPARATOR: 2 Pancreaticogastrostomy for reconstruction after pancreaticoduodenectomy | PROCEDURE: type of anastomosis after pancreaticoduodenectomy
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| pancreatic fistula rate | 30 days |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| mortality | 90 days | |
| Hospital stay | 90 days | |
| need for postoperative intervention | 90 days | |
| major complication | 90 days |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
20 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
