Pancreatic Fistula After Pancreaticoduodenectomy Clinical Trial
Official title:
Isolated Roux Loop Pancreaticojejunostomy Versus Pancreaticogastrostomy After Pancreaticoduodenectomy
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.
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isolated pancreatic drainage group or PG group by closed envelope which withdrawn by the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,
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| No longer available |
NCT06300801 -
Postoperative Pancreatic Fistula in Patients Undergoing Pancreaticoduodenectomy
|