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

NCT ID: NCT03201653

Last Updated: 2017-06-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-31
• Study Completion Date: 2019-12-31

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.

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.

Conditions

Pancreatic Fistula

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Conventional

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

Group Type: ACTIVE_COMPARATOR

Stump closure using NU-KNIT SURGICEL

Intervention Type: PROCEDURE

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

Surgicel

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

Group Type: EXPERIMENTAL

Stump closure using NU-KNIT SURGICEL

Intervention Type: PROCEDURE

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

Interventions

Stump closure using NU-KNIT SURGICEL

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

Intervention Type: PROCEDURE

Other Intervention Names

SURGICEL (Oxidized Regenerated Cellulose)

Eligibility 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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Taiwan University Hospital

Taipei, Taiwan, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Ting-Chun Kuo, MD

Role: CONTACT

tina@ntuh.gov.tw

+886-2-23123456 ext. 63746

Ting-Chun Kuo, MD

Role: CONTACT

tinakuo1204@gmail.com

+886-972653245

Facility Contacts

Yu-Wen Tien, PhD

Role: primary

ywtien5106@ntu.edu.tw

+886-2-23123456 ext. 65083

Ting-Chun Kuo, MD

Role: backup

tina@ntuh.gov.tw

+886-2-23123456 ext. 63746

Other Identifiers

201507019RIND

Identifier Type: -

Identifier Source: org_study_id