An interventional study of Stump closure using NU-KNIT SURGICEL in Pancreatic Fistula, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2017-06-28.
Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment
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.
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.
125 studies on the registry are indexed under Pancreatic Fistula; 27 are open to participants now.
This study's planned enrollment of 84 is below the median of 110 across 75 interventional studies indexed under Pancreatic Fistula.
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Exclusion Criteria:
Stump closure as our institute routine, using interrupted silk mattress suture and continuous prolene sutures.
Procedure: 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.
Procedure: Stump closure using NU-KNIT SURGICEL
We would use the Oxidized Regenerated Cellulose as NU-KNIT SURGICEL.
Also known as: SURGICEL (Oxidized Regenerated Cellulose)
POPF rate
The percentage of overall (grade A, B, C) POPF.
Time frame: through study completion, an average of 16 days
Duration of drainage replacement
Duration of drainage replacement after DP
Time frame: through study completion, an average of 16 days
Hospitalization
Duration of hospital stay after DP
Time frame: through study completion, an average of 16 days
Hospitalization cost
Total hospital cost of for DP
Time frame: through study completion, an average of 16 days
Mortality
Procedure-related mortality after DP
Time frame: 90 days
Plan to share: No
No publications or documents are linked to this record.
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National Taiwan University Hospital