Clinical trial NCT01859806: Isolated Roux Loop Pancreaticojejunostomy Versus Pancreaticogastrostomy After Pancreaticoduodenectomy
Official title: Isolated Roux Loop Pancreaticojejunostomy Versus Pancreaticogastrostomy After Pancreaticoduodenectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Fistula After Pancreaticoduodenectomy
Keywords: periampullary tumour
isolated Roux loop PJ
PG
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2013-05-22
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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PD resection to either isolated Roux PJ with isolated pancreatic drainage group or PG group by closed envelope which withdrawn by the nurse.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

Eligibility criteria: Inclusion Criteria:

* All periampullary tumour either benign or resectable malignant tumour

Exclusion Criteria:

* locally advanced tumour infiltrating SMA
* Metastasis
* unfit

Primary outcomes:
measure: Postoperative pancreatic fistula (POPF)
timeFrame: one year postoperative
Secondary outcomes:
measure: Pancreatic function
timeFrame: one year postoperative
measure: Postoperative complications
timeFrame: one year postoperative
measure: Operative duration
timeFrame: 8 hours
measure: hospital stay
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Ayman El Nakeeb
Study officials:
affiliation: Mansoura University
name: Ayman El Nakeeb, MD
role: PRINCIPAL_INVESTIGATOR
References:
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