Evaluation of a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy

Pancreatic Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01696903
• Other study ID #: SKARV-GLH-001
• Secondary ID: KI-DSGE-DUAS
• Status: Completed
• Phase: N/A
• First received: September 25, 2012
• Last updated: December 19, 2017
• Start date: September 2011
• Est. completion date: November 2015

Study information

• Verified date: December 2017
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Fistula
• Pancreatic Fistula

Intervention

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.

Locations

Country	Name	City	State
Sweden	Department of Upper Abdominal Surgery, Linköping University Hospital	Linköping
Sweden	Department of Surgical gastroenterology, Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Severity of postoperative complications	The severity of postoperative complications as classified by the classification system of postoperative complications adopted for pancreatic surgery.	participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Primary	Clinically Relevant Postoperative Pancreatic Fistula	Postoperative pancreatic fistula as defined by the International Study Group of Pancreatic Fistula	participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary	Associated postoperative morbidity	Postoperative pancreatic fistula and abscesses or fluid collections adjacent to the pancreaticojejunostomy constitute a morbidity event; pancreaticojejunostomy-associated morbidity.	participants will be followed for the duration of hospital stay, an expected average of 2 weeks

External Links

•   Investigation site
•   Investigation site
•   Issuer organization