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Isolated Roux Loop Pancreaticojejunostomy Versus Pancreaticogastrostomy After Pancreaticoduodenectomy

Not Enrolling
Pancreatic Fistula After Pancreaticoduodenectomy

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Trial Information

Isolated Roux Loop Pancreaticojejunostomy Versus Pancreaticogastrostomy After Pancreaticoduodenectomy

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isolated pancreatic drainage group or PG group by closed envelope which withdrawn by the

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,

Inclusion Criteria:

- All periampullary tumour either benign or resectable malignant tumour

Exclusion Criteria:

- locally advanced tumour infiltrating SMA

- Metastasis

- unfit

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Postoperative pancreatic fistula (POPF)

Outcome Description:

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)

Outcome Time Frame:

one year postoperative

Safety Issue:


Principal Investigator

Ayman El Nakeeb, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mansoura University


Egypt: Institutional Review Board

Study ID:

Pancreatic anastomosis



Start Date:

January 2011

Completion Date:

March 2013

Related Keywords:

  • Pancreatic Fistula After Pancreaticoduodenectomy
  • periampullary tumour
  • isolated Roux loop PJ
  • PG
  • Fistula
  • Pancreatic Fistula