Isolated Roux Loop Versus Conventional Pancreaticojejunostomy Following Pancreaticoduodenectomy

Sponsor
Inonu University (Other)
Overall Status
Completed
CT.gov ID
NCT03671031
Collaborator
(none)
109
1
113.9
1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: isolated roux loop
  • Procedure: single loop

Study Design

Study Type:
Observational
Actual Enrollment :
109 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Isolated Roux Loop Versus Conventional Pancreaticojejunostomy Following Pancreaticoduodenectomy
Actual Study Start Date :
Jan 1, 2009
Actual Primary Completion Date :
Jun 30, 2018
Actual Study Completion Date :
Jun 30, 2018

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Severity of postoperative pancreatic fistula [1 week]

    Assessed according to International Study Group on Pancreatic Fistula definition

Secondary Outcome Measures

  1. Rate of postoperative pancreatic fistula [1 week]

    Number of participants with postoperative pancreatic fistula

  2. Operation time [1 week]

    in minutes

  3. Duration of hospital stay [1 week]

    in days

  4. Duration of intensive care unit stay [1 week]

    in days

  5. 30-day mortality [1 week]

    Number of participants died in 30 days after operation

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Inonu University Malatya Turkey

Sponsors and Collaborators

  • Inonu University

Investigators

  • Principal Investigator: Egemen Ozdemir, MD, Inonu University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Egemen Ozdemir, Principal Investigator, Inonu University
ClinicalTrials.gov Identifier:
NCT03671031
Other Study ID Numbers:
  • 2018/16-22
First Posted:
Sep 14, 2018
Last Update Posted:
Sep 25, 2018
Last Verified:
Sep 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Egemen Ozdemir, Principal Investigator, Inonu University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 25, 2018