NCT02563158

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

3 years

First QC Date

September 26, 2015

Last Update Submit

May 10, 2016

Conditions

Liver CancerSurgery

Keywords

liver resectionblood inflow controlischemia-reperfusion injuryinflammatory responserandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Serum total bilirubin on postoperative day 5

    Postoperative liver insufficiency characterized by the serum total bilirubin on POD 5.

    5 days

Secondary Outcomes (10)

  • Intraoperative blood loss

    Entire operation duration

  • Requirement of blood transfusion

    Entire operation duration

  • Operative time

    Entire operation duration

  • Postoperative intensive-care unit (ICU) stay

    Duration of stay in ICU

  • Hospital stay

    Duration of hospital stay

  • +5 more secondary outcomes

Study Arms (2)

Hx with hepatic inflow occlusion

NO INTERVENTION

Hepatectomy is carried out using Pringle maneuver in cycles of 15 minutes clamping + 5 minutes unclamping of the hepatoduodenal ligament.

Hx with non-occlusion technique

EXPERIMENTAL

Hepatectomy without hepatic inflow occlusion (non-occlusion technique)

Procedure: non-occlusion technique

Interventions

non-occlusion techniquePROCEDURE

Hepatectomy is carried out without hepatic inflow control. (non-occlusion technique)

Also known as: hepatectomy without hepatic inflow occlusion
Hx with non-occlusion technique

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Related Publications (9)

  • 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.

    PMID: 14762851RESULT

  • 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.

    PMID: 20137393RESULT

  • 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.

    PMID: 19094562RESULT

  • 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.

    PMID: 23943100RESULT

  • 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.

    PMID: 20632273RESULT

  • 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.

    PMID: 12143206RESULT

  • 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.

    PMID: 19300227RESULT

  • 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.

    PMID: 20409520RESULT

  • 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.

    PMID: 27724929DERIVED

MeSH Terms

Conditions

Liver NeoplasmsReperfusion Injury

Interventions

Hepatectomy

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesVascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Shichun Lu, MD, PhD

    Department of Hepatobiliary Surgery, Chinese PLA General Hospital, 28 Fuxing Road, Haidian, Beijing, 100853, China

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shichun Lu, MD, PhD

CONTACT

+86 10 68160801sclu_301@163.com

Yinzhe Xu, MD, PhD

CONTACT

+1 617 818 4081james_hbp@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Department of Hepatobiliary Surgery

Study Record Dates

First Submitted

September 26, 2015

First Posted

September 30, 2015

Study Start

January 1, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations

CN(1)