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Trial Title:
Pancreaticogastrostomy Versus Pancreaticojejunostomy in Reconstruction After Cephalic Duodenopancreatectomy
NCT ID:
NCT01324856
Condition:
Pancreatic Cancer
Pancreatic Anastomotic Leak
Conditions: Official terms:
Pancreatic Neoplasms
Anastomotic Leak
Conditions: Keywords:
pancreatic cancer
periampulary cancer
pancreaticogastro vs pancreaticojejuno anastomosis
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Pancreatico gastro anastomosis
Description:
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.
Arm group label:
Pancreaticogastro anastomosis
Intervention type:
Procedure
Intervention name:
Pancreaticojejuno anastomosis
Description:
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.
Arm group label:
Pancreaticojejuno anastomosis
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Clinic for Digestive Surgery, Clinical Center of Serbia and School of Medicine University of Belgrade
Address:
City:
Belgrade
Zip:
11000
Country:
Serbia
Contact:
Last name:
Dejan Radenkovic, MD, PhD
Phone:
+381 63 204 205
Email:
dejanr@sbb.rs
Investigator:
Last name:
Dejan Radenkovic, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Clinic for Emergency Surgery, Clinical Center of Serbia and School of Medicine, University of Belgrade
Address:
City:
Belgrade
Zip:
11000
Country:
Serbia
Facility:
Name:
Surgical Department, Clinical Center "Bezanijska Kosa" and School of Medicine, University of Belgrade
Address:
City:
Belgrade
Zip:
11000
Country:
Serbia
Facility:
Name:
Surgical Department, Military-Medical Academy
Address:
City:
Belgrade
Zip:
11000
Country:
Serbia
Start date:
April 2011
Completion date:
September 2013
Lead sponsor:
Agency:
University of Belgrade
Agency class:
Other
Source:
University of Belgrade
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01324856
