- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Beijing
-
Beijing, Beijing, Chine, 100853
- Recrutement
- Chinese PLA General Hospital
-
Contact:
- Yinzhe Xu, M.D., Ph.D.
- Numéro de téléphone: 86-10-66936609
- E-mail: james_hbp@163.com
-
Chercheur principal:
- Shichun Lu, M.D., Ph.D.
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Aucune intervention: 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.
|
|
Expérimental: Hx with non-occlusion technique
Hepatectomy without hepatic inflow occlusion (non-occlusion technique)
|
Hepatectomy is carried out without hepatic inflow control.
(non-occlusion technique)
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Serum total bilirubin on postoperative day 5
Délai: 5 days
|
Postoperative liver insufficiency characterized by the serum total bilirubin on POD 5.
|
5 days
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Intraoperative blood loss
Délai: Entire operation duration
|
Total blood loss from the incision to the closure of abdomen
|
Entire operation duration
|
Requirement of blood transfusion
Délai: Entire operation duration
|
The amount of intraoperative blood transfusion
|
Entire operation duration
|
Operative time
Délai: Entire operation duration
|
The time from induction of anesthesia to the closure of abdomen
|
Entire operation duration
|
Postoperative intensive-care unit (ICU) stay
Délai: Duration of stay in ICU
|
Duration of stay in ICU
|
Duration of stay in ICU
|
Hospital stay
Délai: Duration of hospital stay
|
Duration of hospital stay
|
Duration of hospital stay
|
Total hospital expenditure
Délai: Duration of hospital stay
|
Total costs during hospital stay
|
Duration of hospital stay
|
Perioperative systemic inflammatory response
Délai: 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
Délai: 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
Délai: 5 years after operation
|
1, 3, 5-year tumor recurrence rate
|
5 years after operation
|
Long-term survival
Délai: 5 years after operation
|
1, 3, 5-year overall survival (OS) and disease (tumor)-free survival (DFS)
|
5 years after operation
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Shichun Lu, MD, PhD, Department of Hepatobiliary Surgery, Chinese PLA General Hospital, 28 Fuxing Road, Haidian, Beijing, 100853, China
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- JFJZYY-GD-15-01
- NO. 2012BAI06B01 (Autre subvention/numéro de financement: National Key Technology R&D Program of China)
- NO. 2012ZX10002-017 (Autre subvention/numéro de financement: National S&T Major Project for Infectious Diseases of China)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur non-occlusion technique
-
University of Sao PauloFundação de Amparo à Pesquisa do Estado de São PauloComplétéMâchoire édentée | Bouche édentéeBrésil
-
RadiancyComplétéLombalgie chronique légère à modéréeIsraël
-
Johns Hopkins UniversitySheikh Khalifa Stroke InstituteRecrutementAccident vasculaire cérébral | Faiblesse de la mainÉtats-Unis
-
University of British ColumbiaUniversity of OttawaActif, ne recrute pas
-
Nantes University HospitalComplétéArrêts cardio-respiratoires préhospitaliers | Récupération spontanée de l'activité circulatoireFrance
-
AIDS Malignancy ConsortiumNational Cancer Institute (NCI)RecrutementInfections à VIH | Cancer | Malignité liée au VPH | Cancer anal | Tumeur maligne associée au VIH | Lymphome lié au SIDA | Sarcome de Kaposi lié au SIDA | Malignité liée au SIDAÉtats-Unis
-
Hitit UniversityComplété
-
Dr. Lutfi Kirdar Kartal Training and Research HospitalComplété
-
Purdue UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Complété
-
Texas Scottish Rite Hospital for ChildrenRecrutement