Pancreaticogastrostomy Versus Pancreaticojejunostomy in Reconstruction After Cephalic Duodenopancreatectomy
PanAm
Results of Pancreaticogastrostomy Versus Pancreaticojejunostomy in Reconstruction After Cephalic Duodenopancreatectomy in Patients With Soft Pancreas and Small Pancreatic Duct
1 other identifier
interventional
100
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 pancreatic-cancer
Started Apr 2011
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2011
CompletedFirst Posted
Study publicly available on registry
March 29, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedApril 11, 2011
February 1, 2011
2 years
March 28, 2011
April 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Pancreaticogastro anastomosis
EXPERIMENTALPancreaticojejuno anastomosis
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- Patients undergone cephalic duodenopanceatectomy
- soft pancreas
- small diameter of the pancreatic remnant
You may not qualify if:
- Age bellow 18 and under 80
- prevous pancreatic surgery
- pregnancy
- Psychosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Clinic for Digestive Surgery, Clinical Center of Serbia and School of Medicine University of Belgrade
Belgrade, 11000, Serbia
Clinic for Emergency Surgery, Clinical Center of Serbia and School of Medicine, University of Belgrade
Belgrade, 11000, Serbia
Surgical Department, Clinical Center "Bezanijska Kosa" and School of Medicine, University of Belgrade
Belgrade, 11000, Serbia
Surgical Department, Military-Medical Academy
Belgrade, 11000, Serbia
Related Publications (3)
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.
PMID: 17236843BACKGROUNDBassi 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.
PMID: 16327486BACKGROUNDYeo 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.
PMID: 7574936BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dejan Radenkovic, MD,PhD
Clinic for Digestive disease, Clinical center of Serbia and School of Medicine University of Belgrade
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 28, 2011
First Posted
March 29, 2011
Study Start
April 1, 2011
Primary Completion
April 1, 2013
Study Completion
September 1, 2013
Last Updated
April 11, 2011
Record last verified: 2011-02