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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03201653
Collaborator
(none)
84
Enrollment
1
Location
2
Arms
29
Anticipated Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Stump closure using NU-KNIT SURGICEL
 N/A

Detailed Description

Pancreatic surgery has been called formidable operation not only the technical challenge to surgeons but also demanding for patients. It evolved into a safe procedure with mortality rates of <5% recently, cutting down gradually from 25% in the 1960s. However, overall morbidity rate remained high ranging from 30% to 60%.

Distal pancreatectomy (DP) has been believed a safer and minor procedure compared with pancreatic head resection including standard pancreaticoduodenectomy (PD), pylorus-preserving pancreaticoduodenectomy (PPPD), or duodenum-preserving pancreatic head resection (DPPHR). Whilst postoperative pancreatic fistula (POPF) remains serious and also is one of the most common complications after DP. Büchler et al observed that the POPF rate was in fact significantly higher after DP when compared to pancreatic head resections. The variable documented incidence of POPF following DP ranges from 12% to 40%. POPF after DP is also associated with major complications such as bleeding or septic shock and remains an equivocal problem.

Although the majority of complications are not life-threatening, POPF could prolong hospitalization, expend expenditure for healthcare, abrade the quality of life; moreover, delay in further management for a fraction of patients with malignancy. Over the past two decades, various risk factors and multitudinous operative procedures have been held for reduction POPD following DP. These include underlying disease process, method of stump closure, and concomitant splenectomy However, all these reports were retrospective review, non-randomized study, or individual experience. As always, this issue remains in obscurity and seek for a more concrete evidence to solve.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
84 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
SURGICEL group comparisons to traditional group (each performed at a nominal alpha of 0.05 and power of 0.80) in a 2:1 allocation ratioSURGICEL group comparisons to traditional group (each performed at a nominal alpha of 0.05 and power of 0.80) in a 2:1 allocation ratio
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Prospective Randomized Trial of Efficacy of Stump Closure for Distal Pancreatectomy
Anticipated Study Start Date :
Jul 1, 2017
Anticipated Primary Completion Date :
Jul 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Conventional

Stump closure as our institute routine, using interrupted silk mattress suture and continuous prolene sutures.

Procedure: Stump closure using NU-KNIT SURGICEL
We would use the Oxidized Regenerated Cellulose as NU-KNIT SURGICEL.
Other Names:
  • SURGICEL (Oxidized Regenerated Cellulose)

    		•
    Experimental: Surgicel

    Stump closure modified from our institute routine, using interrupted silk mattress suture and continuous prolene sutures with NU-KNIT SURGICEL overlying for reinforcement.

    Procedure: Stump closure using NU-KNIT SURGICEL
    We would use the Oxidized Regenerated Cellulose as NU-KNIT SURGICEL.
    Other Names:
  • SURGICEL (Oxidized Regenerated Cellulose)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. POPF rate [through study completion, an average of 16 days]

      The percentage of overall (grade A, B, C) POPF.

    Secondary Outcome Measures

    1. Duration of drainage replacement [through study completion, an average of 16 days]

      Duration of drainage replacement after DP

    2. Hospitalization [through study completion, an average of 16 days]

      Duration of hospital stay after DP

    3. Hospitalization cost [through study completion, an average of 16 days]

      Total hospital cost of for DP

    4. Mortality [90 days]

      Procedure-related mortality after DP

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • age>= 20 years

    • scheduled distal pancreatectomy at NTUH

    • unable to realize this trial and willing to sign the informed consent form

    Exclusion Criteria:

    • age< 20 years, pregnent women, breast-feeding women, or mentally illed

    • active malignancy within 2 years

    • received other upper abdomen major surgery

    • scheduled spleen preservation or associated major organ resection

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan University Hospital Taipei city Taiwan 10002

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT03201653
    Other Study ID Numbers:
    • 201507019RIND
    First Posted:
    Jun 28, 2017
    Last Update Posted:
    Jun 28, 2017
    Last Verified:
    Jun 1, 2016
    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 National Taiwan University Hospital
    Distal Pancreatectomy
    Pancreatic Fistula
    Oxidized Regenerated Cellulose
    Pancreatectomy
    Additional relevant MeSH terms:
    Pancreatic Fistula
    Fistula

    Study Results

    No Results Posted as of Jun 28, 2017