Clinical trial NCT01324856: Pancreaticogastrostomy Versus Pancreaticojejunostomy in Reconstruction After Cephalic Duodenopancreatectomy
Official title: Results of Pancreaticogastrostomy Versus Pancreaticojejunostomy in Reconstruction After Cephalic Duodenopancreatectomy in Patients With Soft Pancreas and Small Pancreatic Duct
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Pancreatic Cancer
Pancreatic Anastomotic Leak
Keywords: pancreatic cancer
periampulary cancer
pancreaticogastro vs pancreaticojejuno anastomosis
Lead sponsor: University of Belgrade
Sponsor class: OTHER
First posted: 2011-03-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pancreaticoduodenectomy is the standards surgical procedure for various malignant and benign disease of the pancreas and periampullariy region. During the recent years, mortality rate of pancreaticoduodenectomy has decreased to 5% in specialized centers. Although, this procedure still carries considerable morbidity up to 40%, depending of definition of complications. Pancreatic fistula remains a common complication and the main cause of other morbidities and mortality. Pancreaticojejunal (PJ) anastomosis is the most often used method of reconstruction after pancreaticoduodenectomy. Several technique modifications such as placement of the stents, reinforcement of anasomosis with fibrin glue, pancreatic duct occlusion and pancreaticogastrostomy (PG) type of anastomosis was used in order to decrease pancreatic fistula rate. Since, some retrospective studies showed better results with some technique, several meta-analyses did not show any advantage of those various modifications. It was shown that the higher risk of pancreatic fistula was noticed in patients with soft residual pancreas and small diameter of pancreatic duct. There is only one randomized study in the literature dealing with this problem. This study did not reveal any significant differences between PG and PJ in patients with soft pancreas and small duct. In order to investigate once more this important issue, the researchers conducted randomized multicenter controlled trial.


Eligibility criteria: Inclusion Criteria:

* Patients undergone cephalic duodenopanceatectomy
* soft pancreas
* small diameter of the pancreatic remnant

Exclusion Criteria:

* Age bellow 18 and under 80
* prevous pancreatic surgery
* pregnancy
* Psychosis

Primary outcomes:
measure: abdominal complications
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Clinic for Digestive Surgery, Clinical Center of Serbia and School of Medicine University of Belgrade
city: Belgrade
country: Serbia
facility: Clinic for Emergency Surgery, Clinical Center of Serbia and School of Medicine, University of Belgrade
city: Belgrade
country: Serbia
facility: Surgical Department, Clinical Center "Bezanijska Kosa" and School of Medicine, University of Belgrade
city: Belgrade
country: Serbia
facility: Surgical Department, Military-Medical Academy
Study officials:
affiliation: Clinic for Digestive disease, Clinical center of Serbia and School of Medicine University of Belgrade
name: Dejan Radenkovic, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wente MN, Shrikhande SV, Muller MW, Diener MK, Seiler CM, Friess H, Buchler MW. Pancreaticojejunostomy versus pancreaticogastrostomy: systematic review and meta-analysis. Am J Surg. 2007 Feb;193(2):171-83. doi: 10.1016/j.amjsurg.2006.10.010.
citation: Bassi C, Falconi M, Molinari E, Salvia R, Butturini G, Sartori N, Mantovani W, Pederzoli P. Reconstruction by pancreaticojejunostomy versus pancreaticogastrostomy following pancreatectomy: results of a comparative study. Ann Surg. 2005 Dec;242(6):767-71, discussion 771-3. doi: 10.1097/01.sla.0000189124.47589.6d.
citation: Yeo CJ, Cameron JL, Maher MM, Sauter PK, Zahurak ML, Talamini MA, Lillemoe KD, Pitt HA. A prospective randomized trial of pancreaticogastrostomy versus pancreaticojejunostomy after pancreaticoduodenectomy. Ann Surg. 1995 Oct;222(4):580-8; discussion 588-92. doi: 10.1097/00000658-199510000-00014.