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Clinical Randomized Trial Investigating a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy in Patients With a High Risk for Postoperative Pancreatic Fistula


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Open (Enrolling)
Both
Postoperative Pancreatic Fistula, Pancreatic Texture, Pancreatic Duct Diameter, Pancreatic Consistency, Pancreaticoduodenectomy

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Trial Information

Clinical Randomized Trial Investigating a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy in Patients With a High Risk for Postoperative Pancreatic Fistula


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinically Relevant Postoperative Pancreatic Fistula

Outcome Description:

Postoperative pancreatic fistula as defined by the International Study Group of Pancreatic Fistula

Outcome Time Frame:

participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Safety Issue:

Yes

Principal Investigator

Ralf Segersvärd, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Karolinska Institutet

Authority:

Sweden: National Board of Health and Welfare

Study ID:

SKARV-GLH-001

NCT ID:

NCT01696903

Start Date:

September 2011

Completion Date:

September 2015

Related Keywords:

  • Postoperative Pancreatic Fistula
  • Pancreatic Texture
  • Pancreatic Duct Diameter
  • Pancreatic Consistency
  • Pancreaticoduodenectomy
  • Postoperative pancreatic fistula
  • Pancreatic texture
  • Pancreatic duct diameter
  • Pancreatic consistency
  • Pancreaticoduodenectomy
  • Fistula
  • Pancreatic Fistula

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