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

National Taiwan University

Status: Unknown

Conditions: Pancreatic Fistula

Treatments: Procedure: Stump closure using NU-KNIT SURGICEL

Study type: Interventional

Funder types: Other

Identifiers

NCT03201653

201507019RIND

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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84 participants in 2 patient groups

Conventional

Active Comparator group

Description:

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

Treatment:

Procedure: Stump closure using NU-KNIT SURGICEL

Surgicel

Experimental group

Description:

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

Treatment:

Procedure: Stump closure using NU-KNIT SURGICEL