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Isolated Roux Loop Versus Conventional Pancreaticojejunostomy Following Pancreaticoduodenectomy

Isolated Roux Loop Versus Conventional Pancreaticojejunostomy Following Pancreaticoduodenectomy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03671031
Enrollment
109
Registered
2018-09-14
Start date
2009-01-01
Completion date
2018-06-30
Last updated
2018-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Fistula

Keywords

pancreatic fistula, pancreatic leak, whipple operation, roux-en-y

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.

Interventions

PROCEDUREisolated roux loop

Isolated roux loop reconstruction following pancreaticoduodenectomy

PROCEDUREsingle loop

Conventional single loop reconstruction following pancreaticoduodenectomy

Sponsors

Inonu University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frameDescription
Severity of postoperative pancreatic fistula1 weekAssessed according to International Study Group on Pancreatic Fistula definition

Secondary

MeasureTime frameDescription
Rate of postoperative pancreatic fistula1 weekNumber of participants with postoperative pancreatic fistula
Operation time1 weekin minutes
Duration of hospital stay1 weekin days
Duration of intensive care unit stay1 weekin days
30-day mortality1 weekNumber of participants died in 30 days after operation

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026