CClinicalTrials.gg
Not yet recruitingNCT03672357Updated Dec 13, 2018

Short and Long Outcomes Between Laparoscopic and Open Hepatectomy

An interventional study of Laparoscopic liver resection and Open liver resection in Laparoscopic Liver Resection and Open Liver Resection, sponsored by hui hou. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-12-13.

Sponsored by hui hou · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years 1 month ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

LLR was applied for tumors located at the lower edge and lateral segments of the liver that could be resected more easily than posterosuperior segments. With the development of technology and the growing experience of hepatobiliary surgeons, LLR has been expanded to major liver resections, anatomical resections, and donor hepatectomies by skilled surgeons. However, due to the concerns over the risk of operative bleeding, tumor seeding and positive resection margin, the true benefit of LLR remains unclear across surgical community.

Read the detailed description

The 2nd International Consensus Conference on Laparoscopic Liver Resection (ICCLLR) was held in Morioka, Japan, in 2014. The new recommendations of the ICCLLR state that the outcomes of LLR are not inferior than OLR regarding to operative mortality rate and margin negativity, and are superior in decreasing postoperative complications, blood loss, and the length of the postoperative hospital stay. However, it is not clear that whether LLR is able to alleviate the impairment of liver function after hepatic resection, and there is no RCTs to compare the short and long outcomes between LLR and OLR.

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Conditions studied

  • Laparoscopic Liver Resection
  • Open Liver Resection

Keywords

  • Liver resection
  • Laparoscopic surgery
  • fast recovery
03

In context

Lead sponsor

hui hou is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

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

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patient who underwent hepatectomy for benign or malignant neoplasm of the liver, and is suitable for both open and laparoscopic liver resection;
  2. Child-Pugh A without portal hypertension
  3. No portosystemic shunt
  4. No previous abdominal operation history.
  5. American society of anesthesiology class(ASA): I or II
  6. Age 18 to 80

Exclusion criteria

Exclusion Criteria:

  1. Additional intervention to the liver (Radio Frequent Ablation, Percutaneous Ethanol. Injection Therapy or others)
  2. Combined hepatectomy
  3. Intrahepatic duct stone disease
  4. Liver disease caused splenomegaly
  5. Previous hepatectomy
  6. Combined operation for extrahepatic disease
  7. Vulnerable population (mental retardation, pregnancy)
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Laparoscopic liver resection

    Laparoscopic hepatectomy

    Procedure: Laparoscopic liver resection

  • Other
    Open liver resection

    Open hepatectomy

    Procedure: Open liver resection

Interventions

  • ProcedureLaparoscopic liver resection

    Laparoscopic hepatectomy

  • ProcedureOpen liver resection

    Traditional open hepatectomy

06

What researchers measure

Primary outcomes

  1. Change of serum glutamic oxalacetic transaminase

    Change of serum glutamic oxalacetic transaminase after liver resection.These values will be recorded preoperative, and postoperative day-1,3,5,7.

    Time frame: up to 7 days after liver resection

  2. Change of serum glutamic-pyruvic transaminase

    Change of serum glutamic-pyruvic transaminase after liver resection.These values will be recorded preoperative, and postoperative day-1,3,5,7.

    Time frame: up to 7 days after liver resection

Secondary outcomes

  1. Postoperative complication(Rates in different grades)

    According to The Clavien-Dindo Classification, https://www.assessurgery.com/clavien-dindo-classification/

    Time frame: up to 30 days after liver resection

  2. Mortality rates

    the rate of postoperative death

    Time frame: up to 30 days after liver resection

  3. Hospital duration after operation (days)

    the length of hospital stay

    Time frame: up to 30 days after liver resection

  4. Operation time(min)

    the during of operation

    Time frame: up to 30 days after liver resection

  5. Blood loss(ml)

    the volume of blood loss

    Time frame: up to 30 days after liver resection

  6. Blood transfusion (times and units)

    intraoperative blood transfusion

    Time frame: intraoperative

  7. Duration of nasogastric tubes (hours)

    Duration of nasogastric tubes

    Time frame: up to 14 days after liver resection7

  8. Duration of abdominal drain (days)

    Duration of abdominal drain

    Time frame: up to 14 days after liver resection

  9. Duration to first flatus (days)

    Duration to first flatus

    Time frame: up to 14 days after liver resection

  10. Comfort questionnaire measures (GCQ) measures by Kolcaba

    GCQ measures by Kolcaba, download from http://www.thecomfortline.com/resources/cq.html.

    Time frame: up to 7 days after liver resection

  11. Resection margin status

    the R0 resection rate

    Time frame: up to 30 days after liver resection

  12. Intensive care unit stay (days)

    Intensive care unit stay in days

    Time frame: up to 7 days after liver resection

  13. Readmission rate

    measure the rate of readmission

    Time frame: up to 30 days after liver resection

  14. C-reactive protein (mg/mL)

    C-reactive protein levels on preoperative and postoperative day-1,3,5

    Time frame: up to 5 days after liver resection

  15. Disease recurrence rates

    The disease recurrence after operation

    Time frame: up to 5 years

  16. Overall survival time (month)

    Overall survival time after operation

    Time frame: up to 5 years after operation

  17. Disease free survival time (month)

    Disease free survival time after operation

    Time frame: up to 5 years after operation

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Study locations

1 site
  • The second hospital of Anhui Medical University,
    Hefei, Anhui 230061, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03672357
Lead sponsor
hui hou
Responsible party
hui hou (Director of the hepatobiliary surgery department, The Second Hospital of Anhui Medical University) — Sponsor-investigator
First posted
Sep 14, 2018
Start date
Jan 1, 2019 (estimated)
Primary completion
Sep 1, 2024 (estimated)
Completion
Apr 1, 2025 (estimated)
Last update
Dec 13, 2018

Study contacts

dachen zhou, MD
Contact
zdc1987@yeah.net
+8618160885015

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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