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Evaluation of a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2013 by Karolinska Institutet.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
University Hospital, Linkoeping
Information provided by (Responsible Party):
Christoph Ansorge, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01696903
First received: September 25, 2012
Last updated: March 30, 2015
Last verified: October 2013
History of Changes
  Purpose
Pancreaticoduodenectomy is a surgical procedure for removing cancer in the pancreas, the bile system or the duodenum that is associated with a high rate of complications. The study wants to investigate whether a new technique to reconstruct the joint between the pancreatic gland and the short bowel can reduce the rate of severe complications after this complex surgical procedure.

Condition Intervention
Pancreatic Fistula
 Procedure: Pancreaticojejunostomy technique

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Randomized Trial Investigating a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy in Patients With a High Risk for Postoperative Pancreatic Fistula

Resource links provided by NLM:

MedlinePlus related topics: Fistulas
U.S. FDA Resources

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Clinically Relevant Postoperative Pancreatic Fistula [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: Yes ]
    Postoperative pancreatic fistula as defined by the International Study Group of Pancreatic Fistula


Secondary Outcome Measures:
  • Associated postoperative morbidity [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: Yes ]
    Postoperative pancreatic fistula and abscesses or fluid collections adjacent to the pancreaticojejunostomy constitute a morbidity event; pancreaticojejunostomy-associated morbidity.


Other Outcome Measures:
  • Severity of postoperative complications [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: Yes ]
    The severity of postoperative complications as classified by the classification system of postoperative complications adopted for pancreatic surgery.
Estimated Enrollment: 120
Study Start Date: September 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Conventional anastomosis
Conventional anastomosis: The pancreaticojejunostomy is carried out in a traditional way according to "Cattel's duct-to-mucosa technique".
Active Comparator: Novel anastomosis
Novel anastomosis: This the active comparator to the conventional anastomosis. A new pancreaticojejunostomy technique is used for the reconstruction. The pancreas is intubated into the jejunum.
 Procedure: Pancreaticojejunostomy technique
The anastomosis between jejunum and remnant pancreas has a pivotal impact on the incidence of postoperative pancreatic fistula. by this novel technique the remnant pancreas is intubated into the jejunum without extensive manipulation.
Other Names:
  • Pancreaticojejunal anastomosis
  • Intubating pancreaticojejunostomy
  • Dunking pancreaticojejunostomy
  • pancreatojejunostomy

Detailed Description:
Pancreaticoduodenectomy is a complex surgical procedure for radically resecting tumors in the pancreatic head, distal bile duct or duodenum. Postoperative pancreatic fistula is the main contributor of severe postoperative morbidity after pancreaticoduodenectomy. Characteristics of the pancreatic gland like soft pancreatic consistency and small pancreatic main duct predispose for the postoperative fistula development. In high risk patients, the risk of suffering from associated postoperative morbidity is 50 percent which is considered unacceptable high. The aim of the current trial is to investigate whether a new anastomosing technique for the pancreaticojejunostomy can reduce the incidence of associated postoperative morbidity in patients undergoing pancreaticoduodenectomy.
  Eligibility
Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for elective pancreaticoduodenectomy
  • Pancreatic gland with high risk criteria for associated postoperative morbidity

Exclusion Criteria:

  • Patients do not accept participation
  • Pancreatic gland with intermediate or low risk criteria for associated postoperative morbidity
  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: NCT01696903

Contacts
Contact: Christoph Ansorge, MD, PhD +46734098881 christoph.ansorge@karolinska.se
Contact: Ralf Segersvärd, MD, PhD ralf.segersvard@ki.se

Locations
Sweden
Department of Upper Abdominal Surgery, Linköping University Hospital Recruiting
Linköping, Sweden, 58185
Contact: Thomas Gasslander, MD, PhD       thomas.gasslander@liu.se   
Principal Investigator: Thomas Gasslander, MD, PhD         
Sub-Investigator: Bergthor Björnsson, MD         
Department of Surgical gastroenterology, Karolinska University Hospital Recruiting
Stockholm, Sweden, 14186
Contact: Christoph Ansorge, MD       christoph.ansorge@karolinska.se   
Contact: Ralf Segersvärd, MD, PhD       ralf.segersvard@ki.se   
Principal Investigator: Christoph Ansorge, MD, PhD         
Sub-Investigator: John Blomberg, MD, PhD         
Sponsors and Collaborators
Karolinska Institutet
University Hospital, Linkoeping
Investigators
Principal Investigator: Christoph Ansorge, MD, PhD Karolinska Institutet
Study Director: Ralf Segersvärd, MD, PhD Karolinska Institutet
  More Information

Additional Information:
Issuer organization  This link exits the ClinicalTrials.gov site
Investigation site  This link exits the ClinicalTrials.gov site
Investigation site  This link exits the ClinicalTrials.gov site
Investigation site  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Christoph Ansorge, Christoph Ansorge, MD, PhD, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01696903     History of Changes
Other Study ID Numbers: SKARV-GLH-001  KI-DSGE-DUAS 
Study First Received: September 25, 2012
Last Updated: March 30, 2015
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Karolinska Institutet:
Postoperative pancreatic fistula
Pancreatic texture
Pancreatic duct diameter
Pancreatic consistency
Pancreaticoduodenectomy

Additional relevant MeSH terms:
Fistula
Pancreatic Fistula
Pathological Conditions, Anatomical
 Digestive System Fistula
Digestive System Diseases
Pancreatic Diseases

ClinicalTrials.gov processed this record on September 23, 2016