Isolated Roux Loop Pancreaticojejunostomy Versus Pancreaticogastrostomy After Pancreaticoduodenectomy

Not Applicable

Completed

• Conditions: Pancreatic Fistula After Pancreaticoduodenectomy
• Interventions: Procedure: Isolated Roux PJ group; Procedure: Pancreaticogastrostomy group

• Registration Number: NCT01859806
• Lead Sponsor: Mansoura University

Brief Summary

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

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PD resection to either isolated Roux PJ with isolated pancreatic drainage group or PG group by closed envelope which withdrawn by the nurse.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,

Study Timeline

• Status Verified: 2011-01
• Study Start: 2011-01
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Study First Submitted: 2013-05-14
• Study First Submitted QC: 2013-05-20
• Last Update Submitted: 2013-05-20
• Study First Posted: 2013-05-22
• Last Update Posted: 2013-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• All periampullary tumour either benign or resectable malignant tumour

Exclusion Criteria

• locally advanced tumour infiltrating SMA
• Metastasis
• unfit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Isolated Roux PJ group	Isolated Roux PJ group	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).
Pancreaticogastrostomy group	Pancreaticogastrostomy group	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.

Primary Outcome Measures

Name	Time	Method
Postoperative pancreatic fistula (POPF)	one year postoperative	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)

Secondary Outcome Measures

Name	Time	Method
Operative duration	8 hours	Operative duration
hospital stay	5 weeks	hospital stay,
Pancreatic function	one year postoperative	Steatorrhea, blood glucose, fat in stool
Postoperative complications	one year postoperative	Delayed gastric emptying, bile leakage, bleeding PG, bleeding GJ

Trial Locations

Locations (1)

Ayman El Nakeeb; 🇪🇬 Mansoura, Egypt