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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pancreatic Fistula

Intervention / Treatment
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* Procedure: Stump closure using NU-KNIT SURGICEL


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional<br>Stump closure as our institute routine, using interrupted silk mattress suture and continuous prolene sutures. | Procedure: Stump closure using NU-KNIT SURGICEL<br>* We would use the Oxidized Regenerated Cellulose as NU-KNIT SURGICEL.<br>* Other names: SURGICEL (Oxidized Regenerated Cellulose);|
| Experimental: Surgicel<br>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<br>* We would use the Oxidized Regenerated Cellulose as NU-KNIT SURGICEL.<br>* Other names: SURGICEL (Oxidized Regenerated Cellulose);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| POPF rate | The percentage of overall (grade A, B, C) POPF. | through study completion, an average of 16 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of drainage replacement | Duration of drainage replacement after DP | through study completion, an average of 16 days | 
| Hospitalization | Duration of hospital stay after DP | through study completion, an average of 16 days | 
| Hospitalization cost | Total hospital cost of for DP | through study completion, an average of 16 days | 
| Mortality | Procedure-related mortality after DP | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Distal Pancreatectomy, Pancreatic Fistula, Oxidized Regenerated Cellulose, Pancreatectomy