Isolated Roux Loop Versus Conventional Pancreaticojejunostomy Following Pancreaticoduodenectomy

Study Overview
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Brief Summary
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Pancreaticoduodenectomy is a commonly applied operation for the treatment of benign and malignant diseases of periampullary region. Although recent progress in surgical techniques and medical care reduced the mortality rate of this operation below 5% in some institutes, the morbidity rate still remains high as 40-50% (1,2). Pancreatic anastomotic leaks and fistulas continue to be the main source of morbidity and mortality after pancreaticoduodenectomy. Although there are several recommended techniques to reduce the rate of pancreatic fistulas, optimal pancreatic reconstruction technique is still controversial (3-5). One of the recommended techniques for pancreatic reconstruction is isolated Roux loop pancreaticojejunostomy (6). With this method, as pancreatic anastomosis is kept away from biliary and gastric anastomoses, activation of the pancreatic enzyme precursors is blocked and in this way a reduction in the rate and severity of pancreatic fistula and also in the overall morbidity and mortality can be achieved (6-8). In this study, it is aimed to examine if isolated Roux loop pancreaticojejunostomy is superior to conventional pancreaticojejunostomy on postoperative outcomes.

Official Title
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Isolated Roux Loop Versus Conventional Pancreaticojejunostomy Following Pancreaticoduodenectomy

Conditions
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Pancreatic Fistula

Intervention / Treatment
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* Procedure: isolated roux loop
* Procedure: single loop


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who underwent pancreaticoduodenectomy. Exclusion Criteria: patients with missing data patients who underwent total pancreatectomy patients who had pancreaticogastrostomy as the reconstruction method patients who had emergency pancreaticoduodenectomy
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| isolated roux loop<br>isolated roux loop reconstruction following pancreaticoduodenectomy as the first group. | Procedure: isolated roux loop<br>* Isolated roux loop reconstruction following pancreaticoduodenectomy<br>|
| single loop<br>single loop reconstruction following pancreaticoduodenectomy as the second group. | Procedure: single loop<br>* Conventional single loop reconstruction following pancreaticoduodenectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of postoperative pancreatic fistula | Assessed according to International Study Group on Pancreatic Fistula definition | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of postoperative pancreatic fistula | Number of participants with postoperative pancreatic fistula | 1 week | 
| Operation time | in minutes | 1 week | 
| Duration of hospital stay | in days | 1 week | 
| Duration of intensive care unit stay | in days | 1 week | 
| 30-day mortality | Number of participants died in 30 days after operation | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreatic fistula, pancreatic leak, whipple operation, roux-en-y