- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02563158
Study of Liver Resection With Versus Without Hepatic Inflow Occlusion for the HBV-related HCC (OHx-NOHx)
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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Beijing
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Beijing, Beijing, Kina, 100853
- Rekruttering
- Chinese PLA General Hospital
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Ta kontakt med:
- Yinzhe Xu, M.D., Ph.D.
- Telefonnummer: 86-10-66936609
- E-post: james_hbp@163.com
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Hovedetterforsker:
- Shichun Lu, M.D., Ph.D.
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Elective liver resection due to HBV-related HCC with Barcelona-Clinic Liver Cancer (BCLC) staging 0 or A;
- Child-Pugh classified A with or without cirrhosis, or reversed to A from B after conventional therapy;
- Tumors located either in the left or right hemiliver;
- Resection extent was a hemi-hepatectomy or less;
- Informed consent.
Exclusion Criteria:
- Having comorbidity that contraindicates surgery;
- Participation in concurrent interventional trials with interference to this study;
- Eligible for laparoscopic hepatectomy;
- Requiring concomitant procedures, such as digestive, vascular or biliary reconstruction;
- Lack of compliance for treatment or future follow-up.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Ingen inngripen: 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.
|
|
Eksperimentell: Hx with non-occlusion technique
Hepatectomy without hepatic inflow occlusion (non-occlusion technique)
|
Hepatectomy is carried out without hepatic inflow control.
(non-occlusion technique)
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Serum total bilirubin on postoperative day 5
Tidsramme: 5 days
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Postoperative liver insufficiency characterized by the serum total bilirubin on POD 5.
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5 days
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Intraoperative blood loss
Tidsramme: Entire operation duration
|
Total blood loss from the incision to the closure of abdomen
|
Entire operation duration
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Requirement of blood transfusion
Tidsramme: Entire operation duration
|
The amount of intraoperative blood transfusion
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Entire operation duration
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Operative time
Tidsramme: Entire operation duration
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The time from induction of anesthesia to the closure of abdomen
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Entire operation duration
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Postoperative intensive-care unit (ICU) stay
Tidsramme: Duration of stay in ICU
|
Duration of stay in ICU
|
Duration of stay in ICU
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Hospital stay
Tidsramme: Duration of hospital stay
|
Duration of hospital stay
|
Duration of hospital stay
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Total hospital expenditure
Tidsramme: Duration of hospital stay
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Total costs during hospital stay
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Duration of hospital stay
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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.
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an expected average of 7 days
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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
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an expected average of 12 days in hospital
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Long-term oncologic outcomes
Tidsramme: 5 years after operation
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1, 3, 5-year tumor recurrence rate
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5 years after operation
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Long-term survival
Tidsramme: 5 years after operation
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1, 3, 5-year overall survival (OS) and disease (tumor)-free survival (DFS)
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5 years after operation
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Shichun Lu, MD, PhD, Department of Hepatobiliary Surgery, Chinese PLA General Hospital, 28 Fuxing Road, Haidian, Beijing, 100853, China
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Llovet JM, Fuster J, Bruix J; Barcelona-Clinic Liver Cancer Group. The Barcelona approach: diagnosis, staging, and treatment of hepatocellular carcinoma. Liver Transpl. 2004 Feb;10(2 Suppl 1):S115-20. doi: 10.1002/lt.20034.
- Katz SC, Shia J, Liau KH, Gonen M, Ruo L, Jarnagin WR, Fong Y, D'Angelica MI, Blumgart LH, Dematteo RP. Operative blood loss independently predicts recurrence and survival after resection of hepatocellular carcinoma. Ann Surg. 2009 Apr;249(4):617-23. doi: 10.1097/SLA.0b013e31819ed22f.
- Dong JH, Yang SZ, Duan WD, Ji WB, Cai SW, Wang J, Shi XJ, Jiang K, Xia HT, He L, Zhang WZ, Huang XQ, Huang ZQ. [Clinical application of precise liver resection techniques in patients with complicated liver space-occupying lesions]. Zhonghua Wai Ke Za Zhi. 2009 Nov 1;47(21):1610-5. Chinese.
- Huang ZQ, Xu LN, Yang T, Zhang WZ, Huang XQ, Liu R, Cai SW, Zhang AQ, Feng YQ, Zhou NX, Dong JH. [Liver resection: single center experiences of 2008 consecutive resections in 20 years]. Zhonghua Wai Ke Za Zhi. 2008 Sep 1;46(17):1314-21. Chinese.
- Dong J, Yang S, Zeng J, Cai S, Ji W, Duan W, Zhang A, Ren W, Xu Y, Tan J, Bu X, Zhang N, Wang X, Wang X, Meng X, Jiang K, Gu W, Huang Z. Precision in liver surgery. Semin Liver Dis. 2013 Aug;33(3):189-203. doi: 10.1055/s-0033-1351781. Epub 2013 Aug 13. Danish, English.
- Sugiyama Y, Ishizaki Y, Imamura H, Sugo H, Yoshimoto J, Kawasaki S. Effects of intermittent Pringle's manoeuvre on cirrhotic compared with normal liver. Br J Surg. 2010 Jul;97(7):1062-9. doi: 10.1002/bjs.7039.
- Kim YI, Song KE, Ryeon HK, Hwang YJ, Yun YK, Lee JW, Chun BY. Enhanced inflammatory cytokine production at ischemia/reperfusion in human liver resection. Hepatogastroenterology. 2002 Jul-Aug;49(46):1077-82.
- Fu SY, Lau WY, Li GG, Tang QH, Li AJ, Pan ZY, Huang G, Yin L, Wu MC, Lai EC, Zhou WP. A prospective randomized controlled trial to compare Pringle maneuver, hemihepatic vascular inflow occlusion, and main portal vein inflow occlusion in partial hepatectomy. Am J Surg. 2011 Jan;201(1):62-9. doi: 10.1016/j.amjsurg.2009.09.029. Epub 2010 Apr 20. Erratum In: Am J Surg. 2011 Jul;202(1):117. multiple author names corrected.
- Xu Y, Chen J, Wang H, Zheng H, Feng D, Zhang A, Leng J, Duan W, Yang Z, Chen M, Shi X, Cai S, Ji W, Jiang K, Zhang W, Chen Y, Gu W, Dong J, Lu S. Perioperative and long-term outcomes of liver resection for hepatitis B virus-related hepatocellular carcinoma without versus with hepatic inflow occlusion: study protocol for a prospective randomized controlled trial. Trials. 2016 Oct 11;17(1):492. doi: 10.1186/s13063-016-1621-9.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- JFJZYY-GD-15-01
- NO. 2012BAI06B01 (Annet stipend/finansieringsnummer: National Key Technology R&D Program of China)
- NO. 2012ZX10002-017 (Annet stipend/finansieringsnummer: National S&T Major Project for Infectious Diseases of China)
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