Pancreaticogastrostomy Versus Pancreaticojejunostomy in Reconstruction After Cephalic Duodenopancreatectomy

NCT ID: NCT01324856

Last Updated: 2011-04-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2013-09-30

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.

Conditions

Pancreatic Cancer; Pancreatic Anastomotic Leak

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pancreaticogastro anastomosis

Group Type: EXPERIMENTAL

Pancreatico gastro anastomosis

Intervention Type: PROCEDURE

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

Group Type: ACTIVE_COMPARATOR

Pancreaticojejuno anastomosis

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Belgrade

OTHER

Sponsor Role: lead

Responsible Party

Clinic for Digestive surgery, Clinical Center of Serbia

Principal Investigators

Dejan Radenkovic, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Clinic for Digestive disease, Clinical center of Serbia and School of Medicine University of Belgrade

Locations

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, , Serbia

Countries

Serbia

Central Contacts

Dejan Radenkovic, MD, PhD

Role: CONTACT

dejanr@sbb.rs

+381 63 204 205

Facility Contacts

Dejan Radenkovic, MD, PhD

Role: primary

dejanr@sbb.rs

+381 63 204 205

References

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.

Reference Type: BACKGROUND

PMID: 17236843 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16327486 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 7574936 (View on PubMed)

Other Identifiers

D672

Identifier Type: -

Identifier Source: org_study_id