Evaluation of a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy

This study is currently recruiting participants.
Verified October 2013 by Karolinska Institutet
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: October 6, 2013
Last verified: October 2013

September 25, 2012
October 6, 2013
September 2011
March 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01696903 on ClinicalTrials.gov Archive Site
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.
Same as current
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.
Same as current
 
Evaluation of a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy
Clinical Randomized Trial Investigating a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy in Patients With a High Risk for Postoperative Pancreatic Fistula

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Pancreatic Fistula
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
  • 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.
    Intervention: Procedure: Pancreaticojejunostomy technique

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
September 2015
March 2015   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: Christoph Ansorge, MD, PhD +46734098881 christoph.ansorge@karolinska.se
Contact: Ralf Segersvärd, MD, PhD ralf.segersvard@ki.se
Sweden
 
NCT01696903
SKARV-GLH-001, KI-DSGE-DUAS
No
Christoph Ansorge, Karolinska Institutet
Karolinska Institutet
University Hospital, Linkoeping
Principal Investigator: Christoph Ansorge, MD, PhD Karolinska Institutet
Study Director: Ralf Segersvärd, MD, PhD Karolinska Institutet
Karolinska Institutet
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP