Pancreaticogastrostomy Versus Pancreaticojejunostomy in Reconstruction After Cephalic Duodenopancreatectomy (PanAm)
Primary Purpose
Pancreatic Cancer, Pancreatic Anastomotic Leak
Status
Unknown status
Phase
Phase 1
Locations
Serbia
Study Type
Interventional
Intervention
Pancreatico gastro anastomosis
Pancreaticojejuno anastomosis
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring pancreatic cancer, periampulary cancer, pancreaticogastro vs pancreaticojejuno anastomosis
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
Sites / Locations
- Clinic for Digestive Surgery, Clinical Center of Serbia and School of Medicine University of Belgrade
- Clinic for Emergency Surgery, Clinical Center of Serbia and School of Medicine, University of Belgrade
- Surgical Department, Clinical Center "Bezanijska Kosa" and School of Medicine, University of Belgrade
- Surgical Department, Military-Medical Academy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pancreaticogastro anastomosis
Pancreaticojejuno anastomosis
Arm Description
Outcomes
Primary Outcome Measures
abdominal complications
Abdominal complications comprises: Pancreatic fistula, acute fluid collection, acute pancreatitis, billiay fistula, gastric fistula, enteral distula, hemorrhage and delayed gastric emptying
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01324856
Brief Title
Pancreaticogastrostomy Versus Pancreaticojejunostomy in Reconstruction After Cephalic Duodenopancreatectomy
Acronym
PanAm
Official Title
Results of Pancreaticogastrostomy Versus Pancreaticojejunostomy in Reconstruction After Cephalic Duodenopancreatectomy in Patients With Soft Pancreas and Small Pancreatic Duct
Study Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2013 (Anticipated)
Study Completion Date
September 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Belgrade
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Pancreatic Anastomotic Leak
Keywords
pancreatic cancer, periampulary cancer, pancreaticogastro vs pancreaticojejuno anastomosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pancreaticogastro anastomosis
Arm Type
Experimental
Arm Title
Pancreaticojejuno anastomosis
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Pancreatico gastro anastomosis
Intervention 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.
Intervention Type
Procedure
Intervention Name(s)
Pancreaticojejuno anastomosis
Intervention 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.
Primary Outcome Measure Information:
Title
abdominal complications
Description
Abdominal complications comprises: Pancreatic fistula, acute fluid collection, acute pancreatitis, billiay fistula, gastric fistula, enteral distula, hemorrhage and delayed gastric emptying
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dejan Radenkovic, MD, PhD
Phone
+381 63 204 205
Email
dejanr@sbb.rs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dejan Radenkovic, MD,PhD
Organizational Affiliation
Clinic for Digestive disease, Clinical center of Serbia and School of Medicine University of Belgrade
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic for Digestive Surgery, Clinical Center of Serbia and School of Medicine University of Belgrade
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dejan Radenkovic, MD, PhD
Phone
+381 63 204 205
Email
dejanr@sbb.rs
First Name & Middle Initial & Last Name & Degree
Dejan Radenkovic, MD, PhD
Facility Name
Clinic for Emergency Surgery, Clinical Center of Serbia and School of Medicine, University of Belgrade
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Surgical Department, Clinical Center "Bezanijska Kosa" and School of Medicine, University of Belgrade
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Surgical Department, Military-Medical Academy
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
12. IPD Sharing Statement
Citations:
PubMed Identifier
17236843
Citation
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.
Results Reference
background
PubMed Identifier
16327486
Citation
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.
Results Reference
background
PubMed Identifier
7574936
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. doi: 10.1097/00000658-199510000-00014.
Results Reference
background
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Pancreaticogastrostomy Versus Pancreaticojejunostomy in Reconstruction After Cephalic Duodenopancreatectomy
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