Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Study of Liver Resection With Versus Without Hepatic Inflow Occlusion for the HBV-related HCC (OHx-NOHx)

10. maj 2016 opdateret af: Prof. Shichun Lu, Chinese PLA General Hospital

Short- and Long-term Outcomes of Liver Resection With Versus Without Hepatic Inflow Occlusion for the Hepatitis B Virus-related Hepatocellular Carcinoma: a Prospective Randomized Controlled Trial

The study aims to compare the perioperative and long-term outcomes of liver resection for HBV-related HCC with versus without hepatic inflow occlusion.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

High prevalence of hepatitis B virus (HBV) imposes a huge burden of hepatocellular carcinoma (HCC) in Asia. Liver resection remains the mainstay of treatment for HCC. Hepatic inflow occlusion, known as the Pringle maneuver, is most commonly used to reduce blood loss during liver parenchymal transection. A major issue about this maneuver is the ischemia-reperfusion injury to the remnant liver. And the hemodynamic disturbance to the tumor-bearing liver remains an oncologic concern. Given the technical advances in living donor liver transplantation, vascular occlusion can be avoided in liver resection by experienced hands. This study aims to compare the perioperative and long-term outcomes of liver resection for HBV-related HCC without versus with hepatic inflow occlusion.

This study will include eligible patients with HBV-related HCC elected for liver resection. 57 patients will be enrolled in each randomized arm to detect a 20% difference in the serum level of total bilirubin on postoperative day 5 (80% power and α = 0.05). The secondary endpoints include procedural parameters, perioperative liver function and inflammatory response, postoperative morbidity and mortality, and long-term outcomes. Patients will be followed for up to five years. Data will be statistically analyzed on an intention-to-treat basis.

This prospective randomized controlled trial is designed to evaluate the feasibility of liver resections for HBV-related HCC without vascular occlusion. Clinical implication of its outcomes may change the present surgical practice and fill the oncologic gaps therein.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

114

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Kina
    • Beijing
      • Beijing, Beijing, Kina, 100853
        • Rekruttering
        • Chinese PLA General Hospital
        • Kontakt:
        • Ledende efterforsker:
          • Shichun Lu, M.D., Ph.D.

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

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Elective liver resection due to HBV-related HCC with Barcelona-Clinic Liver Cancer (BCLC) staging 0 or A;
  2. Child-Pugh classified A with or without cirrhosis, or reversed to A from B after conventional therapy;
  3. Tumors located either in the left or right hemiliver;
  4. Resection extent was a hemi-hepatectomy or less;
  5. Informed consent.

Exclusion Criteria:

  1. Having comorbidity that contraindicates surgery;
  2. Participation in concurrent interventional trials with interference to this study;
  3. Eligible for laparoscopic hepatectomy;
  4. Requiring concomitant procedures, such as digestive, vascular or biliary reconstruction;
  5. Lack of compliance for treatment or future follow-up.

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Hx with hepatic inflow occlusion
Hepatectomy is carried out using Pringle maneuver in cycles of 15 minutes clamping + 5 minutes unclamping of the hepatoduodenal ligament.
Eksperimentel: Hx with non-occlusion technique
Hepatectomy without hepatic inflow occlusion (non-occlusion technique)
Procedure: non-occlusion technique
Hepatectomy is carried out without hepatic inflow control. (non-occlusion technique)
Andre navne:
  • hepatectomy without hepatic inflow occlusion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Serum total bilirubin on postoperative day 5
Tidsramme: 5 days
Postoperative liver insufficiency characterized by the serum total bilirubin on POD 5.
5 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Intraoperative blood loss
Tidsramme: Entire operation duration
Total blood loss from the incision to the closure of abdomen
Entire operation duration
Requirement of blood transfusion
Tidsramme: Entire operation duration
The amount of intraoperative blood transfusion
Entire operation duration
Operative time
Tidsramme: Entire operation duration
The time from induction of anesthesia to the closure of abdomen
Entire operation duration
Postoperative intensive-care unit (ICU) stay
Tidsramme: Duration of stay in ICU
Duration of stay in ICU
Duration of stay in ICU
Hospital stay
Tidsramme: Duration of hospital stay
Duration of hospital stay
Duration of hospital stay
Total hospital expenditure
Tidsramme: Duration of hospital stay
Total costs during hospital stay
Duration of hospital stay
Perioperative systemic inflammatory response
Tidsramme: an expected average of 7 days
Perioperative systemic inflammatory response is characterized by elevated serum level of tumor necrosis factor-α (TNF-α), interleukins (IL)-1α, 2, 6, 8 and 10, procalcitonin (PCT) and C-reactive protein (CRP) at different time points.
an expected average of 7 days
Postoperative morbi-mortality
Tidsramme: an expected average of 12 days in hospital
Postoperative morbi-mortality is characterized by postoperative complication and its severity based on Clavien-Dindo classification and in-hospital mortality
an expected average of 12 days in hospital
Long-term oncologic outcomes
Tidsramme: 5 years after operation
1, 3, 5-year tumor recurrence rate
5 years after operation
Long-term survival
Tidsramme: 5 years after operation
1, 3, 5-year overall survival (OS) and disease (tumor)-free survival (DFS)
5 years after operation

Samarbejdspartnere og efterforskere

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

Sponsor

Chinese PLA General Hospital

Efterforskere

  • Ledende efterforsker: Shichun Lu, MD, PhD, Department of Hepatobiliary Surgery, Chinese PLA General Hospital, 28 Fuxing Road, Haidian, Beijing, 100853, China

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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

1. januar 2016

Primær færdiggørelse (Forventet)

1. januar 2019

Studieafslutning (Forventet)

1. januar 2019

Datoer for studieregistrering

Først indsendt

26. september 2015

Først indsendt, der opfyldte QC-kriterier

28. september 2015

Først opslået (Skøn)

30. september 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

12. maj 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. maj 2016

Sidst verificeret

1. maj 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • JFJZYY-GD-15-01
  • NO. 2012BAI06B01 (Andet bevillings-/finansieringsnummer: National Key Technology R&D Program of China)
  • NO. 2012ZX10002-017 (Andet bevillings-/finansieringsnummer: National S&T Major Project for Infectious Diseases of China)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Kirurgi

Kliniske forsøg med non-occlusion technique

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in South Korea

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner