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

Not Applicable

• Conditions: Pancreatic Fistula
• Interventions: Procedure: Stump closure using NU-KNIT SURGICEL

• Registration Number: NCT03201653
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2016-06
• Study First Submitted: 2016-06-21
• Study First Submitted QC: 2017-06-25
• Last Update Submitted: 2017-06-25
• Study First Posted: 2017-06-28
• Last Update Posted: 2017-06-28
• Study Start: 2017-07
• Primary Completion: 2019-07
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
POPF rate	through study completion, an average of 16 days	The percentage of overall (grade A, B, C) POPF.

Secondary Outcome Measures

Name	Time	Method
Mortality	90 days	Procedure-related mortality after DP
Hospitalization cost	through study completion, an average of 16 days	Total hospital cost of for DP
Duration of drainage replacement	through study completion, an average of 16 days	Duration of drainage replacement after DP
Hospitalization	through study completion, an average of 16 days	Duration of hospital stay after DP

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei city, Taiwan