Pancreaticogastrostomy Versus Pancreaticojejunostomy in Reconstruction After Cephalic Duodenopancreatectomy (PanAm)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by University of Belgrade.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Belgrade
ClinicalTrials.gov Identifier:
NCT01324856
First received: March 28, 2011
Last updated: April 8, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Pancreatic Anastomotic Leak
Procedure: Pancreatico gastro anastomosis
Procedure: Pancreaticojejuno anastomosis
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Results of Pancreaticogastrostomy Versus Pancreaticojejunostomy in Reconstruction After Cephalic Duodenopancreatectomy in Patients With Soft Pancreas and Small Pancreatic Duct

Resource links provided by NLM:


Further study details as provided by University of Belgrade:

Primary Outcome Measures:
  • abdominal complications [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Abdominal complications comprises: Pancreatic fistula, acute fluid collection, acute pancreatitis, billiay fistula, gastric fistula, enteral distula, hemorrhage and delayed gastric emptying


Estimated Enrollment: 100
Study Start Date: April 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pancreaticogastro anastomosis 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.
Active Comparator: Pancreaticojejuno anastomosis 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01324856

Contacts
Contact: Dejan Radenkovic, MD, PhD +381 63 204 205 dejanr@sbb.rs

Locations
Serbia
Clinic for Digestive Surgery, Clinical Center of Serbia and School of Medicine University of Belgrade Not yet recruiting
Belgrade, Serbia, 11000
Contact: Dejan Radenkovic, MD, PhD    +381 63 204 205    dejanr@sbb.rs   
Principal Investigator: Dejan Radenkovic, MD, PhD         
Clinic for Emergency Surgery, Clinical Center of Serbia and School of Medicine, University of Belgrade
Belgrade, Serbia, 11000
Surgical Department, Military-Medical Academy
Belgrade, Serbia, 11000
Surgical Department, Clinical Center "Bezanijska Kosa" and School of Medicine, University of Belgrade
Belgrade, Serbia, 11000
Sponsors and Collaborators
University of Belgrade
Investigators
Principal Investigator: Dejan Radenkovic, MD,PhD Clinic for Digestive disease, Clinical center of Serbia and School of Medicine University of Belgrade
  More Information

Publications:
Responsible Party: Dejan Radenkovic, Clinic for Digestive surgery, Clinical Center of Serbia
ClinicalTrials.gov Identifier: NCT01324856     History of Changes
Other Study ID Numbers: D672
Study First Received: March 28, 2011
Last Updated: April 8, 2011
Health Authority: Serbia and Montenegro: Agency for Drugs and Medicinal Devices

Keywords provided by University of Belgrade:
pancreatic cancer
periampulary cancer
pancreaticogastro vs pancreaticojejuno anastomosis

Additional relevant MeSH terms:
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Pancreatic Neoplasms
Anastomotic Leak
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on August 26, 2014