Isolated Roux Loop Versus Conventional Pancreaticojejunostomy Following Pancreaticoduodenectomy

September 23, 2018 updated by: Egemen Ozdemir, Inonu University

Pancreaticoduodenectomy is a commonly applied operation for the treatment of benign and malignant diseases of periampullary region. Although recent progress in surgical techniques and medical care reduced the mortality rate of this operation below 5% in some institutes, the morbidity rate still remains high as 40-50% (1,2). Pancreatic anastomotic leaks and fistulas continue to be the main source of morbidity and mortality after pancreaticoduodenectomy. Although there are several recommended techniques to reduce the rate of pancreatic fistulas, optimal pancreatic reconstruction technique is still controversial (3-5). One of the recommended techniques for pancreatic reconstruction is isolated Roux loop pancreaticojejunostomy (6). With this method, as pancreatic anastomosis is kept away from biliary and gastric anastomoses, activation of the pancreatic enzyme precursors is blocked and in this way a reduction in the rate and severity of pancreatic fistula and also in the overall morbidity and mortality can be achieved (6-8).

In this study, it is aimed to examine if isolated Roux loop pancreaticojejunostomy is superior to conventional pancreaticojejunostomy on postoperative outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

109

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Malatya, Turkey
        • Inonu University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients who underwent pancreaticoduodenectomy at General Surgery Clinic in Inonu University between January 2009 and June 2018

Description

Inclusion Criteria:

  • patients who underwent pancreaticoduodenectomy.

Exclusion Criteria:

  • patients with missing data
  • patients who underwent total pancreatectomy
  • patients who had pancreaticogastrostomy as the reconstruction method
  • patients who had emergency pancreaticoduodenectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
isolated roux loop
isolated roux loop reconstruction following pancreaticoduodenectomy as the first group.
Procedure: isolated roux loop
Isolated roux loop reconstruction following pancreaticoduodenectomy
single loop
single loop reconstruction following pancreaticoduodenectomy as the second group.
Procedure: single loop
Conventional single loop reconstruction following pancreaticoduodenectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of postoperative pancreatic fistula
Time Frame: 1 week
Assessed according to International Study Group on Pancreatic Fistula definition
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of postoperative pancreatic fistula
Time Frame: 1 week
Number of participants with postoperative pancreatic fistula
1 week
Operation time
Time Frame: 1 week
in minutes
1 week
Duration of hospital stay
Time Frame: 1 week
in days
1 week
Duration of intensive care unit stay
Time Frame: 1 week
in days
1 week
30-day mortality
Time Frame: 1 week
Number of participants died in 30 days after operation
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inonu University

Investigators

  • Principal Investigator: Egemen Ozdemir, MD, Inonu University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2009

Primary Completion (ACTUAL)

June 30, 2018

Study Completion (ACTUAL)

June 30, 2018

Study Registration Dates

First Submitted

September 11, 2018

First Submitted That Met QC Criteria

September 12, 2018

First Posted (ACTUAL)

September 14, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 25, 2018

Last Update Submitted That Met QC Criteria

September 23, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/16-22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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