An interventional study of Pancreaticojejunostomy technique in Pancreatic Fistula, sponsored by Karolinska Institutet. Completed at 2 sites in Sweden. Per ClinicalTrials.gov, last updated 2017-12-20.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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.
125 studies on the registry are indexed under Pancreatic Fistula; 27 are open to participants now.
This study's enrollment of 123 is above the median of 110 across 75 interventional studies indexed under Pancreatic Fistula.
Browse Pancreatic Fistula studies →Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.
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Exclusion Criteria:
Conventional anastomosis: The pancreaticojejunostomy is carried out in a traditional way according to "Cattell's duct-to-mucosa technique".
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.
Also known as: Pancreaticojejunal anastomosis, Intubating pancreaticojejunostomy, Dunking pancreaticojejunostomy, pancreatojejunostomy
Clinically Relevant Postoperative Pancreatic Fistula
Postoperative pancreatic fistula as defined by the International Study Group of Pancreatic Fistula
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Associated postoperative morbidity
Postoperative pancreatic fistula and abscesses or fluid collections adjacent to the pancreaticojejunostomy constitute a morbidity event; pancreaticojejunostomy-associated morbidity.
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Severity of postoperative complications
The severity of postoperative complications as classified by the classification system of postoperative complications adopted for pancreatic surgery.
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Karolinska Institutet