Clinical trial NCT01696903: Evaluation of a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy
Official title: Clinical Randomized Trial Investigating a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy in Patients With a High Risk for Postoperative Pancreatic Fistula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Fistula
Keywords: Postoperative pancreatic fistula
Pancreatic texture
Pancreatic duct diameter
Pancreatic consistency
Pancreaticoduodenectomy
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: University Hospital, Linkoeping
First posted: 2012-10-02
Enrollment: 123
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Clinically Relevant Postoperative Pancreatic Fistula
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary outcomes:
measure: Associated postoperative morbidity
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Other outcomes:
measure: Severity of postoperative complications
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Locations:
city: Linköping
country: Sweden
facility: Department of Upper Abdominal Surgery, Linköping University Hospital
city: Stockholm
country: Sweden
facility: Department of Surgical gastroenterology, Karolinska University Hospital
Study officials:
affiliation: Karolinska Institutet
name: Christoph Ansorge, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institutet
name: Ralf Segersvärd, MD, PhD
role: STUDY_DIRECTOR
References:
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. doi: 10.1016/j.surg.2005.05.001.
citation: Ansorge C, Strommer L, Andren-Sandberg A, Lundell L, Herrington MK, Segersvard 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.
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.