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

NCT03201653 | Unknown

• 1 other identifier: 201507019RIND
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Fistula

Keywords

Distal Pancreatectomy; Pancreatic Fistula; Oxidized Regenerated Cellulose; Pancreatectomy

Outcome Measures

Primary Outcomes (1)

• POPF rate

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

  through study completion, an average of 16 days

Secondary Outcomes (4)

• Duration of drainage replacement

  through study completion, an average of 16 days

• Hospitalization

  through study completion, an average of 16 days

• Hospitalization cost

  through study completion, an average of 16 days

• Mortality

  90 days

Study Arms (2)

Conventional

ACTIVE COMPARATOR

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

Procedure: Stump closure using NU-KNIT SURGICEL

Surgicel

EXPERIMENTAL

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

Interventions

Stump closure using NU-KNIT SURGICEL PROCEDURE

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

Also known as: SURGICEL (Oxidized Regenerated Cellulose)

Conventional; Surgicel

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age\>= 20 years
• scheduled distal pancreatectomy at NTUH
• unable to realize this trial and willing to sign the informed consent form

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 10002, Taiwan

RECRUITING

MeSH Terms

Conditions

Pancreatic Fistula

Interventions

Surgicel

Condition Hierarchy (Ancestors)

Digestive System Fistula; Digestive System Diseases; Pancreatic Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ting-Chun Kuo, MD

CONTACT

+886-2-23123456; tina@ntuh.gov.tw

Ting-Chun Kuo, MD

CONTACT

+886-972653245; tinakuo1204@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 21, 2016
• First Posted: June 28, 2017
• Study Start: July 1, 2017
• Primary Completion: July 1, 2019
• Study Completion: December 1, 2019
• Last Updated: June 28, 2017

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)