Clinical trial NCT03201653: A Prospective Randomized Trial of Efficacy of Stump Closure for Distal Pancreatectomy
Official title: A Prospective Randomized Trial of Efficacy of Stump Closure for Distal Pancreatectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreatic Fistula
Keywords: Distal Pancreatectomy
Pancreatic Fistula
Oxidized Regenerated Cellulose
Pancreatectomy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2017-06-28
Enrollment: 84
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: POPF rate
timeFrame: through study completion, an average of 16 days
Secondary outcomes:
measure: Duration of drainage replacement
timeFrame: through study completion, an average of 16 days
measure: Hospitalization
timeFrame: through study completion, an average of 16 days
measure: Hospitalization cost
timeFrame: through study completion, an average of 16 days
measure: Mortality
timeFrame: 90 days
Other outcomes:
Locations:
city: Taipei city
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References: