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OpenTrials
Completed

NCT Number: NCT03671031

Isolated Roux Loop Versus Conventional Pancreaticojejunostomy Following Pancreaticoduodenectomy

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Inonu University

Malatya, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

isolated roux loop

Procedure

Isolated roux loop reconstruction following pancreaticoduodenectomy

single loop

Procedure

Conventional single loop reconstruction following pancreaticoduodenectomy

Primary outcomes

  1. Severity of postoperative pancreatic fistula

    Time frame: 1 week

    Assessed according to International Study Group on Pancreatic Fistula definition

Secondary outcomes

  1. Rate of postoperative pancreatic fistula

    Time frame: 1 week

    Number of participants with postoperative pancreatic fistula

  2. Operation time

    Time frame: 1 week

    in minutes

  3. Duration of hospital stay

    Time frame: 1 week

    in days

  4. Duration of intensive care unit stay

    Time frame: 1 week

    in days

  5. 30-day mortality

    Time frame: 1 week

    Number of participants died in 30 days after operation

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Important dates

Study start
2009
Primary completion
2018
Study completion
2018
First posted
Sep 14, 2018
Registry last updated
Sep 25, 2018

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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