Isolated Roux Loop Pancreaticojejunostomy Versus Pancreaticogastrostomy After Pancreaticoduodenectomy

Study Overview
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Brief Summary
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Pancreaticoduodenectomy (PD)is the treatment of choice for patients with periampullary tumour (benign or malignant). In the recent years, the mortality rate of PD has decreased to 5% in many centers. However, pancreatic fistula (POPF) still occurs in 5 % to 40% of patients after PD. The hypothesis that isolated Roux loop PJ with isolated pancreatic drainage decrease the incidence of PF and severity with preservation of pancreatic function. So the investigators compare isolated Roux Loop Pancreaticojejunostomy (PJ) Versus Pancreaticogastrostomy (PG) as regards incidence of POPF, severity of POPF and functional outcome.

Detailed Description
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The hypothesis that isolated Roux loop PJ decrease the incidence of PF and severity with preservation of pancreatic function (exocrine and endocrine functions). Preoperative evaluation included abdominal CT, liver function, tumor marker CEA, CA19-9, preoperative ERCP were optional in selected cases (patients with high bilirubin with high enzymes. Patients with distant metastasis or locally advanced were excluded. Informed consent was obtained from all patients entered in the study Randomization: enrolled patients were randomized intraoperatively after PD resection to either isolated Roux PJ with isolated pancreatic drainage group or PG group by closed envelope which withdrawn by the nurse. Operative technique. Standard PD with regional lymphadenectomy was performed. PG was done between pancreatic stump and posterior surface of the stomach with 2 layer interrupted anastomosis,and duct to mucosa. Isolated Roux PJ group, reconstruction was begun using the transected jejunum and, which was anastomosed in end to side fashion. A separate Roux loop was performed for HJ, by dividing the jejunum about 40 cm beyond the pancreatic anastomosis and GJ was done in this loop (30 cm caudally from HJ). The PJ loop was anastomosed to the main loop (20 cm caudal to GJ). One intrabdominal drains in morrison space. Intraoperative data and postoperative data were collected. Pancreatic function assessment. The primary outcome was assessment the incidence of POPF after isolated Roux PJ and PG. The secondary outcomes were intraoperative blood loss, drain amount,day to resume oral intake hospital stay, operative duration, pancreatic function, postoperative complications delayed gastric emptying,

Official Title
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Isolated Roux Loop Pancreaticojejunostomy Versus Pancreaticogastrostomy After Pancreaticoduodenectomy

Conditions
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Pancreatic Fistula After Pancreaticoduodenectomy

Intervention / Treatment
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* Procedure: Pancreaticogastrostomy group
* Procedure: Isolated Roux PJ group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All periampullary tumour either benign or resectable malignant tumour Exclusion Criteria: locally advanced tumour infiltrating SMA Metastasis unfit
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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pancreaticogastrostomy group<br>Standard PD with regional lymphadenectomy was performed. PG was done between pancreatic stump and posterior surface of the stomach with 2 layer interrupted anastomosis,and duct to mucosa. | Procedure: Pancreaticogastrostomy group<br>* Standard PD with regional lymphadenectomy was performed. PG was done between pancreatic stump and posterior surface of the stomach with 2 layer interrupted anastomosis,and duct to mucosa.<br>* Other names: Group 1;|
| Active Comparator: Isolated Roux PJ group<br>Isolated Roux PJ group, reconstruction was begun using the transected jejunum and ,which was anastomosed in end to side fashion. A separate Roux loop was performed for HJ, by dividing the jejunum about 40 cm beyond the pancreatic anastomosis and GJ was done in this loop (30 cm caudally from HJ). The PJ loop was anastomosed to the main loop (20 cm caudal to GJ). | Procedure: Isolated Roux PJ group<br>* Isolated Roux PJ group, reconstruction was begun using the transected jejunum and ,which was anastomosed in end to side fashion. A separate Roux loop was performed for HJ, by dividing the jejunum about 40 cm beyond the pancreatic anastomosis and GJ was done in this loop (30 cm caudally from HJ). The PJ loop was anastomosed to the main loop (20 cm caudal to GJ).<br>* Other names: Group 2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pancreatic fistula (POPF) | Postoperative pancreatic fistula was defined as drainage of > 50 ml/d of amylase rich fluid( 3 folds elevation above upper limit of normal in serum) | one year postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pancreatic function | Steatorrhea, blood glucose, fat in stool | one year postoperative | 
| Postoperative complications | Delayed gastric emptying, bile leakage, bleeding PG, bleeding GJ | one year postoperative | 
| Operative duration | Operative duration | 8 hours | 
| hospital stay | hospital stay, | 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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periampullary tumour, isolated Roux loop PJ, PG