- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03201653
A Prospective Randomized Trial of Efficacy of Stump Closure for Distal Pancreatectomy
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Taipei city, Taiwan, 10002
- Rekruttering
- National Taiwan University Hospital
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Kontakt:
- Ting-Chun Kuo, MD
- Telefonnummer: 63746 +886-2-23123456
- E-mail: tina@ntuh.gov.tw
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Kontakt:
- Yu-Wen Tien, PhD
- Telefonnummer: 65083 +886-2-23123456
- E-mail: ywtien5106@ntu.edu.tw
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: Conventional
Stump closure as our institute routine, using interrupted silk mattress suture and continuous prolene sutures.
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We would use the Oxidized Regenerated Cellulose as NU-KNIT SURGICEL.
Andre navne:
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Eksperimentel: Surgicel
Stump closure modified from our institute routine, using interrupted silk mattress suture and continuous prolene sutures with NU-KNIT SURGICEL overlying for reinforcement.
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We would use the Oxidized Regenerated Cellulose as NU-KNIT SURGICEL.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
POPF rate
Tidsramme: through study completion, an average of 16 days
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The percentage of overall (grade A, B, C) POPF.
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through study completion, an average of 16 days
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Duration of drainage replacement
Tidsramme: through study completion, an average of 16 days
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Duration of drainage replacement after DP
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through study completion, an average of 16 days
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Hospitalization
Tidsramme: through study completion, an average of 16 days
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Duration of hospital stay after DP
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through study completion, an average of 16 days
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Hospitalization cost
Tidsramme: through study completion, an average of 16 days
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Total hospital cost of for DP
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through study completion, an average of 16 days
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Mortality
Tidsramme: 90 days
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Procedure-related mortality after DP
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90 days
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 201507019RIND
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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