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Liver CancerOHx-NOHxNCT02563158

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

A study testing non-occlusion technique in people with Liver Cancer and Surgery, run by Chinese PLA General Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Liver Cancer, Surgery
What is being tested?
non-occlusion technique
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
1 siteChina
Study dates
Jan 2016to Jan 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Shichun Lu, MD, PhD contact

+86 10 68160801

sclu_301@163.com

Yinzhe Xu, MD, PhD contact

+1 617 818 4081

james_hbp@163.com

China1 site, 1 recruiting

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853

    Yinzhe Xu, M.D., Ph.D., 86-10-66936609, james_hbp@163.com

    Shichun Lu, M.D., Ph.D.

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the detailed description

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.

Being tested
non-occlusion technique
Keywords
liver resection, blood inflow control, ischemia-reperfusion injury, inflammatory response, randomized controlled trial
Medical subject headings
Liver Neoplasms, Reperfusion Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • non-occlusion techniqueProcedure or surgery

    Also called hepatectomy without hepatic inflow occlusion

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

Study groups in NCT02563158
Study groupRoleWhat they receive
Hx with hepatic inflow occlusionNo interventionHepatectomy is carried out using Pringle maneuver in cycles of 15 minutes clamping + 5 minutes unclamping of the hepatoduodenal ligament.
Hx with non-occlusion techniqueExperimentalHepatectomy without hepatic inflow occlusion (non-occlusion technique)
Receives: Procedure: non-occlusion technique

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum total bilirubin on postoperative day 5

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

    Measured: 5 days

Secondary outcomes (10)

  1. Intraoperative blood loss

    Total blood loss from the incision to the closure of abdomen

    Measured: Entire operation duration

  2. Requirement of blood transfusion

    The amount of intraoperative blood transfusion

    Measured: Entire operation duration

  3. Operative time

    The time from induction of anesthesia to the closure of abdomen

    Measured: Entire operation duration

  4. Postoperative intensive-care unit (ICU) stay

    Duration of stay in ICU

    Measured: Duration of stay in ICU

  5. Hospital stay

    Duration of hospital stay

    Measured: Duration of hospital stay

  6. Total hospital expenditure

    Total costs during hospital stay

    Measured: Duration of hospital stay

  7. Perioperative systemic inflammatory response

    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.

    Measured: an expected average of 7 days

  8. Postoperative morbi-mortality

    Postoperative morbi-mortality is characterized by postoperative complication and its severity based on Clavien-Dindo classification and in-hospital mortality

    Measured: an expected average of 12 days in hospital

  9. Long-term oncologic outcomes

    1, 3, 5-year tumor recurrence rate

    Measured: 5 years after operation

  10. Long-term survival

    1, 3, 5-year overall survival (OS) and disease (tumor)-free survival (DFS)

    Measured: 5 years after operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2015 (estimated)
  2. Study startJan 2016
  3. Primary completionJan 2019 (estimated)
  4. Study completionJan 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
114 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02563158
Sponsor's protocol ID
JFJZYY-GD-15-01
Other IDs
NO. 2012BAI06B01, NO. 2012ZX10002-017
Acronym
OHx-NOHx
Status last verified
May 2016
First submitted
26 Sep 2015
Last updated
12 May 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 14762851

  • 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.

    PubMed 20137393

  • 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.

    PubMed 19094562

  • 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.

    PubMed 23943100

  • 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.

    PubMed 20632273

  • 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.

    PubMed 12143206

  • 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.

    PubMed 19300227

  • 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.

    PubMed 20409520

  • 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.

    PubMed 27724929

Questions about this trial

What is this clinical trial studying?

A study testing non-occlusion technique in people with Liver Cancer and Surgery, run by Chinese PLA General Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Shichun Lu, MD, PhD (+86 10 68160801, sclu_301@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum total bilirubin on postoperative day 5 (time frame: 5 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02563158, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.

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