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

25. juni 2017 opdateret af: National Taiwan University Hospital
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.

Studieoversigt

Status

Ukendt

Betingelser

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

Interventionel

Tilmelding (Forventet)

84

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Taipei city, Taiwan, 10002
        • Rekruttering
        • National Taiwan University Hospital
        • Kontakt:
          • Ting-Chun Kuo, MD
          • Telefonnummer: 63746 +886-2-23123456
          • E-mail: tina@ntuh.gov.tw
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Conventional
Stump closure as our institute routine, using interrupted silk mattress suture and continuous prolene sutures.
We would use the Oxidized Regenerated Cellulose as NU-KNIT SURGICEL.
Andre navne:
  • SURGICEL (Oxidized Regenerated Cellulose)
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.
We would use the Oxidized Regenerated Cellulose as NU-KNIT SURGICEL.
Andre navne:
  • SURGICEL (Oxidized Regenerated Cellulose)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
POPF rate
Tidsramme: through study completion, an average of 16 days
The percentage of overall (grade A, B, C) POPF.
through study completion, an average of 16 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Duration of drainage replacement
Tidsramme: through study completion, an average of 16 days
Duration of drainage replacement after DP
through study completion, an average of 16 days
Hospitalization
Tidsramme: through study completion, an average of 16 days
Duration of hospital stay after DP
through study completion, an average of 16 days
Hospitalization cost
Tidsramme: through study completion, an average of 16 days
Total hospital cost of for DP
through study completion, an average of 16 days
Mortality
Tidsramme: 90 days
Procedure-related mortality after DP
90 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. juli 2017

Primær færdiggørelse (Forventet)

1. juli 2019

Studieafslutning (Forventet)

1. december 2019

Datoer for studieregistrering

Først indsendt

21. juni 2016

Først indsendt, der opfyldte QC-kriterier

25. juni 2017

Først opslået (Faktiske)

28. juni 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. juni 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juni 2017

Sidst verificeret

1. juni 2016

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

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INGEN

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Kliniske forsøg med Bugspytkirtelfistel

Kliniske forsøg med Stump closure using NU-KNIT SURGICEL

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