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

June 25, 2017 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

84

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ting-Chun Kuo, MD
  • Phone Number: 63746 +886-2-23123456
  • Email: tina@ntuh.gov.tw

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei city, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
POPF rate
Time Frame: through study completion, an average of 16 days
The percentage of overall (grade A, B, C) POPF.
through study completion, an average of 16 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of drainage replacement
Time Frame: through study completion, an average of 16 days
Duration of drainage replacement after DP
through study completion, an average of 16 days
Hospitalization
Time Frame: through study completion, an average of 16 days
Duration of hospital stay after DP
through study completion, an average of 16 days
Hospitalization cost
Time Frame: through study completion, an average of 16 days
Total hospital cost of for DP
through study completion, an average of 16 days
Mortality
Time Frame: 90 days
Procedure-related mortality after DP
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2017

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

June 21, 2016

First Submitted That Met QC Criteria

June 25, 2017

First Posted (Actual)

June 28, 2017

Study Record Updates

Last Update Posted (Actual)

June 28, 2017

Last Update Submitted That Met QC Criteria

June 25, 2017

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201507019RIND

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Fistula

Clinical Trials on Stump closure using NU-KNIT SURGICEL

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malta

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe