Pancreaticogastrostomy Versus Pancreaticojejunostomy in Reconstruction After Cephalic Duodenopancreatectomy

Pancreatic Cancer Clinical Trial

— PanAm  

Official title:

Results of Pancreaticogastrostomy Versus Pancreaticojejunostomy in Reconstruction After Cephalic Duodenopancreatectomy in Patients With Soft Pancreas and Small Pancreatic Duct

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01324856
• Other study ID #: D672
• Status: Not yet recruiting
• Phase: Phase 1
• First received: March 28, 2011
• Last updated: April 8, 2011
• Start date: April 2011
• Est. completion date: September 2013

Study information

• Verified date: February 2011
• Source: University of Belgrade
• Contact: Dejan Radenkovic, MD, PhD
• Phone: +381 63 204 205
• Email: dejanr[@]sbb.rs
• Is FDA regulated: No
• Health authority: Serbia and Montenegro: Agency for Drugs and Medicinal Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: September 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anastomotic Leak
• Pancreatic Anastomotic Leak
• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• Pancreatico gastro anastomosis
After the pylorus preserving cephalic pancreaticoduodenectomy, pancreatico gasto teremino-lateral anastomosis will be performed. The anastomosis will be done with posterior wall of the stomach. Pancreas will be mobilized at least 5 cm, two tobaco stiches will be applied on posterior wall of the stomach and hole of 2 cm will be done in the middle. Anterior wall of the stomach will be opened, for easier placement of the pancreas in to the stomach cavity. Pancreas will be entered in the stomach trough , tobacco stitches tided and just 2 or 3 stitches will be applied on the stomach mucosa and pancreatic capsule. After that classic hepatico jejuno and antecolic duodeno jejuno anatomosis will ber performed.
• Pancreaticojejuno anastomosis
After the pylorus preserving cephalic pancreaticoduodenectomy, pancreatico jejuno termino lateral duct to mucosa anastomosis will be performed. After that classic hepatico jejuno and antecolic duodeno jejuno anatomosis will ber performed.

Locations

Country	Name	City	State
Serbia	Clinic for Digestive Surgery, Clinical Center of Serbia and School of Medicine University of Belgrade	Belgrade
Serbia	Clinic for Emergency Surgery, Clinical Center of Serbia and School of Medicine, University of Belgrade	Belgrade
Serbia	Surgical Department, Clinical Center "Bezanijska Kosa" and School of Medicine, University of Belgrade	Belgrade
Serbia	Surgical Department, Military-Medical Academy	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
University of Belgrade

Country where clinical trial is conducted

Serbia, 

References & Publications (3)

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. — View Citation

Wente MN, Shrikhande SV, Müller MW, Diener MK, Seiler CM, Friess H, Büchler MW. Pancreaticojejunostomy versus pancreaticogastrostomy: systematic review and meta-analysis. Am J Surg. 2007 Feb;193(2):171-83. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	abdominal complications	Abdominal complications comprises: Pancreatic fistula, acute fluid collection, acute pancreatitis, billiay fistula, gastric fistula, enteral distula, hemorrhage and delayed gastric emptying	2 years	No