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

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ClinicalTrials.gov Identifier: NCT03201653
Recruitment Status : Recruiting
First Posted : June 28, 2017
Last Update Posted : June 28, 2017
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

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
Pancreatic Fistula Procedure: Stump closure using NU-KNIT SURGICEL Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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 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
Estimated Study Start Date : July 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

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 Name: 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 Name: SURGICEL (Oxidized Regenerated Cellulose)




Primary Outcome Measures :
  1. POPF rate [ Time Frame: 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 [ Time Frame: through study completion, an average of 16 days ]
    Duration of drainage replacement after DP

  2. Hospitalization [ Time Frame: through study completion, an average of 16 days ]
    Duration of hospital stay after DP

  3. Hospitalization cost [ Time Frame: through study completion, an average of 16 days ]
    Total hospital cost of for DP

  4. Mortality [ Time Frame: 90 days ]
    Procedure-related mortality after DP



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201653


Contacts
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Contact: Ting-Chun Kuo, MD +886-2-23123456 ext 63746 tina@ntuh.gov.tw
Contact: Ting-Chun Kuo, MD +886-972653245 tinakuo1204@gmail.com

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei city, Taiwan, 10002
Contact: Yu-Wen Tien, PhD    +886-2-23123456 ext 65083    ywtien5106@ntu.edu.tw   
Contact: Ting-Chun Kuo, MD    +886-2-23123456 ext 63746    tina@ntuh.gov.tw   
Sponsors and Collaborators
National Taiwan University Hospital

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03201653     History of Changes
Other Study ID Numbers: 201507019RIND
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: June 28, 2017
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Fistula
Pancreatic Fistula
Pathological Conditions, Anatomical
Digestive System Fistula
Digestive System Diseases
Pancreatic Diseases