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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03201653
Enrollment
84
Registered
2017-06-28
Start date
2017-07-31
Completion date
2019-12-31
Last updated
2017-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Fistula

Keywords

Distal Pancreatectomy, Pancreatic Fistula, Oxidized Regenerated Cellulose, Pancreatectomy

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.

Interventions

PROCEDUREStump closure using NU-KNIT SURGICEL

We would use the Oxidized Regenerated Cellulose as NU-KNIT SURGICEL.

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

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

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
POPF ratethrough study completion, an average of 16 daysThe percentage of overall (grade A, B, C) POPF.

Secondary

MeasureTime frameDescription
Duration of drainage replacementthrough study completion, an average of 16 daysDuration of drainage replacement after DP
Hospitalizationthrough study completion, an average of 16 daysDuration of hospital stay after DP
Hospitalization costthrough study completion, an average of 16 daysTotal hospital cost of for DP
Mortality90 daysProcedure-related mortality after DP

Countries

Taiwan

Contacts

Primary ContactTing-Chun Kuo, MD
tina@ntuh.gov.tw+886-2-23123456
Backup ContactTing-Chun Kuo, MD
tinakuo1204@gmail.com+886-972653245

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026