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OpenTrials
Completed

NCT Number: NCT01696903

Evaluation of a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy

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.

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Key information

Conditions

Pancreatic Fistula Digestive System Diseases Digestive System Fistula Fistula Pancreatic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Upper Abdominal Surgery, Linköping University Hospital, Linköping, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pancreaticojejunostomy technique

Procedure

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

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • University Hospital, Linkoeping

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Oct 2, 2012
Registry last updated
Dec 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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