Pancreaticogastrostomy Versus Pancreaticojejunostomy in Reconstruction After Cephalic Duodenopancreatectomy (PanAm)

University of Belgrade

Status and phase: Unknown; Phase 1

Conditions: Pancreatic Anastomotic Leak; Pancreatic Cancer

Treatments: Procedure: Pancreaticojejuno anastomosis; Procedure: Pancreatico gastro anastomosis

Study type: Interventional

Funder types: Other

Identifiers

NCT01324856

D672

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Pancreaticogastro anastomosis

Experimental group

Treatment:

Procedure: Pancreatico gastro anastomosis

Pancreaticojejuno anastomosis

Active Comparator group

Treatment:

Procedure: Pancreaticojejuno anastomosis