Hepatocellular CarcinomaLapCHCNCT04791735
Value of the Laparoscopic Approach in the Surgical Management of Resectable Hepatocellular Carcinoma
A study testing Laparoscopy and Laparotomy in people with Hepatocellular Carcinoma, run by Assistance Publique - Hôpitaux de Paris at 17 sites in France.
Trial summary
Hepatocellular carcinoma treated by laparotomy or laparoscopic Multicenter prospective, open, superiority, controlled, randomized, clinical trial The primary objective of the study will be to demonstrate the superiority of the laparoscopic approach over the open approach in reducing postoperative morbidity in HCC… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Laparoscopy and Laparotomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 17 sitesFrance
- Study dates
- 21 May 2021to 7 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient aged ≥ 18 years
- Presenting with solitary or multifocal resectable HCC
- Qualifying for both pure laparoscopic and open approaches
Who cannot join
- Physical or psychological status contraindicating the participation to the study
- Contraindication to surgery
- Contraindication to pneumoperitoneum
- ASA (American Society of Anesthesiologists) score IV-V
- Life expectancy < 2 months
- Suspicion of mixed type tumor (Hepatocholangiocarcinoma) and fibrolamellar HCC
Show all 14Show fewer
- Child-Pugh score > B7
- Extra-hepatic involvement
- Liver resection requiring an associated vascular or biliary reconstruction
- Pregnancy and breast-feeding
- Tutorship, trusteeship
- Concurrent participation in other experimental trials concerning the same objective within 90 days following intervention
- No Affiliation to the French social security
- No Ability to give their consent and not written informed consent
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
Chirurgie Digestive - CHU Amiens
Amiens, France, 80054
Chirurgie viscérale et digestive - CHU Besançon
Besançon, France, 25000
Chirurgie Hépatologie - Hôpital Beaujon
Clichy, France, 92110
Chirurgie Digestive et Hépatobiliaire - Hôpital Henri-Mondor
Créteil, France, 94010
Chirurgie Digestive et de l'Urgence - CHU Grenoble
Grenoble, France, 38700
Chirurgie Digestive et Transplantations - Hôpital Huriez
Lille, France, 59021
Chirurgie Générale, Digestive et de la Transplantation hépatique - Hôpital de la Croix Rousse
Lyon, France, 69317
Chirurgie Digestive - Hôpital La Timone
Marseille, 13005
Chirurgie Digestive - CHU Montpellier
Montpellier, France, 34090
Chirurgie digestive - Institut Mutualiste Montsouris
Paris, France, 75014
Cochin hospital
Paris, France, 75014
Chirurgie hépato-biliaire et greffe de foie - La Pitié
Paris, France, 75651
CHU Rennes - Pontchaillou
Rennes
Chirurgie viscérale et digestive - CHU Rouen
Rouen, France, 76000
Chirurgie hépato-bilio-pancréatique et Transplantation - Hôpital Rangueil
Toulouse, France, 31059
Chirurgie digestive Oncologique Endocrinienne et Transplantation hépatique - CHU Tours
Tours, France, 37000
Centre hépatobiliaire de transplantation hépatique - Hopital Paul Brousse
Villejuif, France, 94800
About this study
Official title: Value of the Laparoscopic Approach in the Surgical Management of Resectable Hepatocellular Carcinoma: a Randomized Controlled Trial
Hepatocellular carcinoma treated by laparotomy or laparoscopic Multicenter prospective, open, superiority, controlled, randomized, clinical trial The primary objective of the study will be to demonstrate the superiority of the laparoscopic approach over the open approach in reducing postoperative morbidity in HCC patients.
Postoperative morbidity will be assessed using the Comprehensive Complication Index (CCI) within 90 days postoperatively or at any time during hospitalization
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Laparoscopy, Laparotomy
- Keywords
- laparoscopy, laparotomy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaparoscopyProcedure or surgery
- Installations of the patient: the position of the patient will depend on both extent of resection and location of the lesion.
- Absence of laparotomy with the exception of the extraction of the resected specimen and absence of costal retractors.
- Use of laparoscopic specific devices:
- Use of multiple (3-7) ports depending on the operator's preference and technical difficulty (mainly 5-6 ports for major liver resection).
- Use of a laparoscopic camera system with 0° or 30°
- Use of a dedicated laparoscopic ultrasound probe.
- Use of specific laparoscopic devices for coagulation, parenchymal transection and sealing.
- Placement of the resected specimen in a plastic bag and extraction without fragmentation, depending on the surgeon's preferenceand the diameter of the resected specimen
LaparotomyProcedure or surgery
- Installation of the patient: patients will be placed in supine position, the surgeon operating on the right side of the patient and the assistant standing on the left side.
- Incision: the type of incision will depend on both the nature of the resection and the operator's preference. Various incisions such as bi subcostal incision, J-shaped incision, right subcostal incision and midline incision can be used.
- Use of open surgical instruments and devices for coagulation and parenchymal transection. These may include the crush-clamp technique or ultrasonic dissection for parenchymal transection, bipolar coagulation, clips, sutures or open vascular stapler for hemostasis and biliostasis.
- Methylene blue injection through the cystic drain to rule out biliary leakage will be performed depending on the surgeon's preference.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic approach for liver resection of HCC | Experimental | Not described Receives: Procedure: Laparoscopy |
| laparotomy | Experimental | Not described Receives: Procedure: Laparotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of the study will be to demonstrate the superiority of the laparoscopic approach over the open approach in reducing postoperative morbidity in HCC patients.
Postoperative morbidity will be assessed using the Comprehensive Complication Index (CCI) within 90 days postoperatively or at any time during hospitalization
Measured: 90 days after inclusion
Secondary outcomes (15)
Number of postoperative complications (grade at least 1 according to the Dindo-Clavien classification) within 90 days postoperatively or at any time during hospitalization.
Measured: 90 days after inclusion
Number of postoperative complications (grade at least 3 according to the Dindo-Clavien classification) within 90 days postoperatively or at any time during hospitalization.
Measured: 90 days after inclusion
All-cause mortality (grade 5 according to the Dindo-Clavien classification or a CCI of 100) within 90 days postoperatively or at any time during hospitalization.
Measured: 90 days after inclusion
Occurrence of specific liver related complications (ascites, liver failure, biliary fistula, hemorrhage) within 90 days postoperatively or at any time during hospitalization.
Measured: 90 days after inclusion
Occurrence of organ space and superficial surgical site infection (SSI) within 90 days postoperatively or at any time during hospitalization.
Measured: 90 days after inclusion
Occurrence of abdominal wall complications (abscess, hematoma) within 90 days postoperatively or at any time during hospitalization.
Measured: 90 days after inclusion
Occurrence of postoperative pulmonary complications (pleural effusion, respiratory insufficiency, acute respiratory distress syndrome, pulmonary embolism) within 90 days postoperatively or at any time during hospitalization.
Measured: 90 days after inclusion
Occurrence of unplanned reoperation within 90 days postoperatively or at any time during hospitalization.
Measured: 90 days after inclusion
Postoperative pain evaluated with a visual analogic scale on postoperative D0, D1, D2, D3, D5, D7 and discharge.
EVA is visual analogic scale 0 to 10, graduation of 1 0 is no pain ans 10 is maximum pain
Measured: day of surgery, 1, 2, 3, 5 and 7 days after surgery
Length of hospital stay and occurrence of unplanned readmission after discharge within 90 days postoperatively
Measured: 90 days after inclusion
Postoperative Quality Recovery Scale (PQRS) on postoperative D7, D30 and D90
PQRS = Postoperative Suality Recovery Scane self-questionary Min = 20 and Max = 120
Measured: 1, 3, 5, 7, 30, 60, 90 days after inclusion
Mean surgical margin widths (in millimeters).
Measured: inclusion
Percentages of microscopically complete (R0), microscoically incomplete (R1) and macroscopically incomplete (R2) resections as stated in the pathological report.
Measured: inclusion
Percentage of patients recurring within 2 years following liver resection.
This cut-off value is widely accepted for differentiating recurrence of the resected lesion (< 2 years postoperatively) from de novo lesion occurring on a background diseased liver parenchyma (> 2 years).
Measured: inclusion
Overall and disease free survivals.
percentage of hepatocellular carcinoma recurrence percentage of deaths at end of follow-up
Measured: 60 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start21 May 2021
- Primary completion30 Apr 2025
- Study completion7 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- the intervention group is Laparoscopic approach for liver resection of HCC The standard arm is the open approach for liver resection of HCC. Both this standard arm and the laparoscopic arm are in the realm of usual care.
- Masking
- None (open label)
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791735
- Sponsor's protocol ID
- APHP180681
- Acronym
- LapCHC
- Status last verified
- May 2025
- First submitted
- 7 Jan 2021
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of the Laparoscopic Approach in the Surgical Management of Resectable Hepatocellular Carcinoma: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04791735
- Acronym / sponsor ID
- LapCHC / APHP180681
- Conditions
- Hepatocellular Carcinoma
- Keywords
- laparoscopy, laparotomy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 21 May 2021 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 7 May 2027 (estimated)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hepatocellular carcinoma treated by laparotomy or laparoscopic Multicenter prospective, open, superiority, controlled, randomized, clinical trial The primary objective of the study will be to demonstrate the superiority of the laparoscopic approach over the open approach in reducing postoperative morbidity in HCC patients.
Postoperative morbidity will be assessed using the Comprehensive Complication Index (CCI) within 90 days postoperatively or at any time during hospitalization
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- the intervention group is Laparoscopic approach for liver resection of HCC The standard arm is the open approach for liver resection of HCC. Both this standard arm and the laparoscopic arm are in the realm of usual care.
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic approach for liver resection of HCC | Experimental | Procedure: Laparoscopy |
| laparotomy | Experimental | Procedure: Laparotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female patient aged ≥ 18 years
- Presenting with solitary or multifocal resectable HCC
- Qualifying for both pure laparoscopic and open approaches
Key exclusion criteria (14 listed)
- Physical or psychological status contraindicating the participation to the study
- Contraindication to surgery
- Contraindication to pneumoperitoneum
- ASA (American Society of Anesthesiologists) score IV-V
- Life expectancy < 2 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopy* Installations of the patient: the position of the patient will depend on both extent of resection and location of the lesion. * Absence of laparotomy with the exception of the extraction of the resected specimen and absence of costal retractors. * Use of laparoscopic specific devices: * Use of multiple (3-7) ports depending on the operator's preference and technical difficulty (mainly 5-6 ports for major liver resection). * Use of a laparoscopic camera system with 0° or 30° * Use of a dedicated laparoscopic ultrasound probe. * Use of specific laparoscopic devices for coagulation, parenchymal transection and sealing. * Placement of the resected specimen in a plastic bag and extraction without fragmentation, depending on the surgeon's preferenceand the diameter of the resected specimen | Procedure or surgery | Laparoscopic approach for liver resection of HCC |
| Laparotomy* Installation of the patient: patients will be placed in supine position, the surgeon operating on the right side of the patient and the assistant standing on the left side. * Incision: the type of incision will depend on both the nature of the resection and the operator's preference. Various incisions such as bi subcostal incision, J-shaped incision, right subcostal incision and midline incision can be used. * Use of open surgical instruments and devices for coagulation and parenchymal transection. These may include the crush-clamp technique or ultrasonic dissection for parenchymal transection, bipolar coagulation, clips, sutures or open vascular stapler for hemostasis and biliostasis. * Methylene blue injection through the cystic drain to rule out biliary leakage will be performed depending on the surgeon's preference. | Procedure or surgery | laparotomy |
Primary outcome
The primary objective of the study will be to demonstrate the superiority of the laparoscopic approach over the open approach in reducing postoperative morbidity in HCC patients.
Time frame: 90 days after inclusion
Postoperative morbidity will be assessed using the Comprehensive Complication Index (CCI) within 90 days postoperatively or at any time during hospitalization
15 secondary outcomes
Number of postoperative complications (grade at least 1 according to the Dindo-Clavien classification) within 90 days postoperatively or at any time during hospitalization.
Time frame: 90 days after inclusion
Number of postoperative complications (grade at least 3 according to the Dindo-Clavien classification) within 90 days postoperatively or at any time during hospitalization.
Time frame: 90 days after inclusion
All-cause mortality (grade 5 according to the Dindo-Clavien classification or a CCI of 100) within 90 days postoperatively or at any time during hospitalization.
Time frame: 90 days after inclusion
Occurrence of specific liver related complications (ascites, liver failure, biliary fistula, hemorrhage) within 90 days postoperatively or at any time during hospitalization.
Time frame: 90 days after inclusion
Occurrence of organ space and superficial surgical site infection (SSI) within 90 days postoperatively or at any time during hospitalization.
Time frame: 90 days after inclusion
Occurrence of abdominal wall complications (abscess, hematoma) within 90 days postoperatively or at any time during hospitalization.
Time frame: 90 days after inclusion
Occurrence of postoperative pulmonary complications (pleural effusion, respiratory insufficiency, acute respiratory distress syndrome, pulmonary embolism) within 90 days postoperatively or at any time during hospitalization.
Time frame: 90 days after inclusion
Occurrence of unplanned reoperation within 90 days postoperatively or at any time during hospitalization.
Time frame: 90 days after inclusion
Postoperative pain evaluated with a visual analogic scale on postoperative D0, D1, D2, D3, D5, D7 and discharge.
Time frame: day of surgery, 1, 2, 3, 5 and 7 days after surgery
Length of hospital stay and occurrence of unplanned readmission after discharge within 90 days postoperatively
Time frame: 90 days after inclusion
Postoperative Quality Recovery Scale (PQRS) on postoperative D7, D30 and D90
Time frame: 1, 3, 5, 7, 30, 60, 90 days after inclusion
Mean surgical margin widths (in millimeters).
Time frame: inclusion
Percentages of microscopically complete (R0), microscoically incomplete (R1) and macroscopically incomplete (R2) resections as stated in the pathological report.
Time frame: inclusion
Percentage of patients recurring within 2 years following liver resection.
Time frame: inclusion
Overall and disease free survivals.
Time frame: 60 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopy and Laparotomy in people with Hepatocellular Carcinoma, run by Assistance Publique - Hôpitaux de Paris at 17 sites in France.
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 3 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective of the study will be to demonstrate the superiority of the laparoscopic approach over the open approach in reducing postoperative morbidity in HCC patients. (time frame: 90 days after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 May 2025.