Evaluation of a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Pancreatic Fistula	Procedure: Pancreaticojejunostomy technique	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	123 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	September 2011
Actual Primary Completion Date :	November 2015
Actual Study Completion Date :	November 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
No Intervention: Conventional anastomosis; Conventional anastomosis: The pancreaticojejunostomy is carried out in a traditional way according to "Cattell'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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Clinically Relevant Postoperative Pancreatic Fistula [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]
   Postoperative pancreatic fistula as defined by the International Study Group of Pancreatic Fistula

Secondary Outcome Measures :

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

Other Outcome Measures:

1. Severity of postoperative complications [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]
   The severity of postoperative complications as classified by the classification system of postoperative complications adopted for pancreatic surgery.

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Sweden
Department of Upper Abdominal Surgery, Linköping University Hospital
Linköping, Sweden, 58185
Department of Surgical gastroenterology, Karolinska University Hospital
Stockholm, Sweden, 14186

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Issuer organization 

Investigation site 

Investigation site 

Publications:

Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, Neoptolemos J, Sarr M, Traverso W, Buchler M; International Study Group on Pancreatic Fistula Definition. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005 Jul;138(1):8-13. Review.

Ansorge C, Strömmer L, Andrén-Sandberg Å, Lundell L, Herrington MK, Segersvärd R. Structured intraoperative assessment of pancreatic gland characteristics in predicting complications after pancreaticoduodenectomy. Br J Surg. 2012 Aug;99(8):1076-82. doi: 10.1002/bjs.8784. Epub 2012 May 4.

Kennedy EP, Yeo CJ. Dunking pancreaticojejunostomy versus duct-to-mucosa anastomosis. J Hepatobiliary Pancreat Sci. 2011 Nov;18(6):769-74. doi: 10.1007/s00534-011-0429-y. Review.

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 ( Other Identifier: Karolinska Institutet )
First Posted:	October 2, 2012
Last Update Posted:	December 20, 2017
Last Verified:	December 2017

Keywords provided by Christoph Ansorge, 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