CClinicalTrials.gg
Status unknownNCT01608386AA+IVCUpdated Aug 6, 2015

A Study of Anterior Approach Combined With Infrahepatic Inferior Vena Cava Clamping

An interventional study of IVC clamping in Surgical Approach & Incisions and Blood Loss, sponsored by Eastern Hepatobiliary Surgery Hospital. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-08-06.

Sponsored by Eastern Hepatobiliary Surgery Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2015), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Anterior approach results in better operative and survival outcomes compared with the conventional approach in patients with large hepatocellular carcinoma (HCC), but anterior approach has the problem of bleeding from the hepatic vein.

Our previous study showed that infrahepatic inferior vena cava (IVC) clamping can reduce blood loss during conventional hepatic resection. The investigators guess infrahepatic IVC clamping may also reduce blood loss in anterior approach right hepatic resection. So the investigators conduct this prospective, randomized, controlled trial to compare anterior approach combined with infrahepatic IVC clamping and anterior approach in major right hepatectomy for large HCC.

Read the detailed description

Traditionally, mobilisation of the right hemiliver followed by right hepatic vein control before parenchymal transection has been considered the standard approach to a major right hepatectomy. However, this approach is often difficult and hazardous when performing liver resection for large hepatocellular carcinoma (HCC) or for tumors with extrahepatic organ invasion in the right retrohepatic region.In setting of right hepatectomy by an anterior approach,liver mobilisation is performed only at the end of parenchymal transection, when all vascular connections have already been interrupted.The anterior approach was found to be associated with significantly less intraoperative blood loss, less blood transfusions and a lower hospital mortality rate.However,excessive bleeding can occur at the deeper plane of parenchymal transection from the right hepatic vein or middle hepatic vein.

Bleeding from the hepatic veins is closely related to the CVP.Our previous retrospective analysisfound that the infrahepatic inferior vena cava (IVC) clamping is efficacious in reducing CVP without the need of systemic fluid restriction and is associated with significantly less intraoperative blood loss during complex hepatectomy.

The aim of the present study was therefore to evaluate if the application of the anterior approach combined with infrahepatic IVC clamping during right hepatectomy for large HCC reduces intraoperative blood loss.

02

Conditions studied

  • Surgical Approach & Incisions
  • Blood Loss

Keywords

  • Anterior approach
  • infrahepatic inferior vena cava clamping
  • hepatic resection
03

In context

Hemorrhage

3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 1,985 interventional studies indexed under Hemorrhage.

Browse Hemorrhage studies →

Lead sponsor

Eastern Hepatobiliary Surgery Hospital is the lead sponsor of 66 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Understanding and being willing to sign the informed consent form
  • Aged 18-75 years
  • Diagnosed HCC by clinical findings and radiography,tumor size ≥ 5cm and located in the right lobe, need to perform right hemihepatectomy or major right hepatic resection (three Couinaud's segments)
  • Without any surgery contraindication
  • Child-Pugh grade A

Exclusion criteria

Exclusion Criteria:

  • Refusal to take part in the study
  • With lymph node or extrahepatic metastases
  • History of previous hepatectomy or other abdominal operation
  • Those who can not be follow-up
  • Non-HCC
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    anterior approach+IVC clamping

    Use anterior approach combined with infrahepatic Inferior Vena Cava clamping in right hepatectomy for HCC patients.

    Procedure: IVC clamping

  • No intervention
    anterior approach

    Only use anterior approach in right hepatectomy for HCC patients.

Interventions

  • ProcedureIVC clamping

    in right hepatectomy,use anterior approach and infrahepatic Inferior Vena Cava clamping.

06

What researchers measure

Primary outcomes

  1. intraoperative total blood loss

    Time frame: participants will be followed for the duration of the entire operation,an expected average of 140 minutes

Secondary outcomes

  1. operation time

    Time frame: the duration of the entire operation,an expected average of 140 minutes

  2. intraoperative CVP value

    Time frame: participants will be followed for the duration of the parenchymal transection,an expected average of 20 minutes

  3. morbidity and mortality

    Time frame: participants will be followed for the duration of the postoperative hospital stay,an expected average of 15 days

  4. postoperative hepatorenal function

    Time frame: postoperative day 1,3 and 7

  5. postoperative hospital stay

    Time frame: the duration of the postoperative hospital stay,an expected average of 15 days

  6. disease-free survival duration and overall survival duration

    Time frame: the duration from operation to recurrence or death,an expected average of 3 years

  7. blood loss during parenchymal transection

    Time frame: the duration of the parenchymal transection,an expected average of 20 minutes

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01608386
Lead sponsor
Eastern Hepatobiliary Surgery Hospital
Collaborators
The First Affiliated Hospital of Xiamen University
Responsible party
Chengjun Sui,MD (Clinical Professor, Eastern Hepatobiliary Surgery Hospital) — Principal investigator
First posted
May 31, 2012
Start date
May 2012
Primary completion
Dec 2015 (estimated)
Completion
Dec 2015 (estimated)
Last update
Aug 6, 2015

Study contacts

Jiamei Yang, MD
study director · Eastern Hepatobiliary Surgery Hospital
Chengjun Sui, MD
principal investigator · Eastern Hepatobiliary Surgery Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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