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A Prospective Randomized Trial of Efficacy of Stump Closure for Distal Pancreatectomy

NCT03201653 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2017-06-28

No results posted yet for this study

Summary

Overall morbidity rate remained high after distal pancreatectomy (DP), ranging from 30% to 60%. Whilst postoperative pancreatic fistula (POPF) remains serious and also is one of the most common complications after DP (12% to 40%). POPF after DP is also associated with major complications such as bleeding or septic shock and remains an equivocal problem. However, all the previous reports were retrospective review, non-randomized study, or individual experience and showed no significant improvement of overall POPF. As always, this issue remains in obscurity and seek for a more concrete evidence to solve.

Conditions

  • Pancreatic Fistula

Interventions

PROCEDURE

Stump closure using NU-KNIT SURGICEL

We would use the Oxidized Regenerated Cellulose as NU-KNIT SURGICEL.

Sponsors & Collaborators

  • National Taiwan University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-31
Primary Completion
2019-07-31
Completion
2019-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03201653 on ClinicalTrials.gov