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Liver Metastasis Colon CancerMETALAPNCT04163887

Effect of the Laparoscopic Approach in Reducing Postoperative Severe Complications Following Hepatectomy for Colorectal Liver Metastases

A study testing hepatectomy in people with Liver Metastasis Colon Cancer and Postoperative Complications, run by Institut Mutualiste Montsouris at 21 sites in France.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 objective of this study is to demonstrate the superiority of the laparoscopic approach over the open approach in the resection of colorectal liver metastases, by examining the reduction of postoperative complications (including mortality), measured using the Comprehensive Complication Index (CCI) within 90 days of… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
hepatectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
340 participants
Where
21 sitesFrance
Study dates
27 Jan 2021to 27 Jan 2026
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Presenting with colorectal liver metastases requiring liver resection ± concomitant radiofrequency ablation.
  • Qualifying for both a laparoscopic approach and an open approach.
  • Informed written consent.
  • Affiliated to health insurance regimen.

Who cannot join

  • Hybrid liver resection (including both laparoscopic and open resection).
  • Liver resection requiring an associated vascular or biliary reconstruction.
  • Contraindication to surgery.
  • Contraindication to laparoscopy (pneumoperitoneum).
  • ASA (American Society of Anesthesiologists) score IV or V or life expectancy < 3 months.
  • Poor comprehension of French language or cognitive impairment
Show all 9Show fewer
  • Pregnancy or breastfeeding.
  • Patient under guardianship or unable to give consent
  • People particularly protected by French law.

Trial locations and contacts

21 sites in 1 country.

Caroline RIX contact

+33 156616371

caroline.rix@imm.fr

Nassima OUDAFAL contact

+33 156616675

nassima.oudafal@imm.fr

21 sites in 1 country

France21 sites, 21 recruiting

  • CHU Amiens Picardie

    Amiens

    Jean-Marc Regimbeau, Regimbeau.Jean-Marc@chu-amiens.fr

    Not yet recruiting

  • Hôpital Côte de Nacre - Chu Caen

    Caen

    jean Lubrano, lubrano-j@chu-caen.fr

    Not yet recruiting

  • CHU Estaing

    Clermont-Ferrand

    Emmanuel Buc, ebuc@chu-clermontferrand.fr

    Not yet recruiting

  • Hôpital Beaujon

    Clichy

    François CAUCHY, francois.cauchy@aphp.fr

    Recruiting

  • CHU Henri Mondor

    Créteil

    Alexis Laurent, alexis.laurent@aphp.fr

    Recruiting

  • CHU de Grenoble

    Grenoble

    Mircea Chirica, mircea.chirica@chu-grenoble.fr

    Not yet recruiting

  • Hôpital Claude Huriez

    Lille

    François-René Pruvot, francois-rene.pruvot@chru-lille.fr

    Not yet recruiting

  • HCL - Hôpital Croix Rousse

    Lyon

    Jean-Yves Mabrut, mabrut.jean-yves@chu-lyon.fr

    Not yet recruiting

  • CHU de Marseille Hôpital de Timone

    Marseille

    Jean Hardwigsen, Jean.HARDWIGSEN@ap-hm.fr

    Not yet recruiting

  • l'Institut Paoli Calmettes

    Marseille

    Olivier Turrini, turrinio@ipc.unicancer.fr

    Not yet recruiting

  • CHU de Montpellier

    Montpellier

    Jean-Michel Fabre, jean-michel.fabre@chu-montpellier.fr

    Not yet recruiting

  • CHU de Nancy - Hôpitaux Brabois

    Nancy

    Ahmet Ayav, a.ayav@chu-nancy.fr

    Not yet recruiting

  • Institut Mutualiste Montsouris

    Paris, 75014

    Ecoline TRIBILLON, Dr, ecoline.tribillon@imm.fr

    Recruiting

  • Hôpital Cochin

    Paris

    David FUKS, david.fuks@aphp.fr

    Recruiting

  • Hôpital La pitié Salpêtrière

    Paris

    Olivier Scatton, olivier.scatton@aphp.fr

    Recruiting

  • CHU de Reims

    Reims

    Reza Kianmanesh, rkianmanesh@chu-reims.fr

    Not yet recruiting

  • Hôpital Charles Nicolle

    Rouen

    Lilian Schwarz, lilian.schwarz@chu-rouen.fr

    Not yet recruiting

  • CHU de Strasbourg - Nouvel Hôpital Civil

    Strasbourg

    Patrick Pessaux, patrick.pessaux@chru-strasbourg.fr

    Not yet recruiting

  • CHU Rangueil

    Toulouse

    Fabrice Muscari, muscari.f@chu-toulouse.fr

    Not yet recruiting

  • Hôpital Trousseau

    Tours

    Ephrem Salamé, e.salame@chu-tours.fr

    Not yet recruiting

  • Hôpital Paul Brousse

    Villejuif

    Daniel Cherqui, daniel.cherqui@aphp.fr

    Recruiting

Other trials in France

About this study

Official title: Effect of the Laparoscopic Approach in Reducing Postoperative Severe Complications Following Hepatectomy for Colorectal Liver Metastases: Prospective, Randomized, Controlled Study

The objective of this study is to demonstrate the superiority of the laparoscopic approach over the open approach in the resection of colorectal liver metastases, by examining the reduction of postoperative complications (including mortality), measured using the Comprehensive Complication Index (CCI) within 90 days of the procedure or regardless of the date during the hospital stay.

Read the detailed description

While laparotomy is still the standard approach of resectable colorectal liver mestastases, its associated morbidity remains non-negligible with reported mortality and complications rates ranging from 2 to 8% and 30 to 70%, respectively (1). Besides the underlying liver disease together with the comorbidities of the patients, this high morbidity is also related to the type of surgical approach. Since less than 15% of liver resections are currently performed using the laparoscopic approach in France, a trial showing the superiority of the laparoscopic approach in comparison to the open approach for patients with colorectal liver metastases qualifying for both approaches would allow improving management of patients, reducing the length of stay, maybe decreasing the global cost and changing current practices on a national scale.

In order to demonstrate the superiority of the laparoscopic approach over the laparotomy approach, patients with colorectal hepatic metastasis will be randomly assigned to either the laparoscopy or laparotomy groups. Post-operative complications (including mortality) will be measured using the Comprehensive Complication Index (CCI) within 90 days postoperatively or at any time during hospitalization. The participation time for each patient in the study is 3 years, the patient will be followed at 1, 3, 6, 9, 9, 12, 15, 18, 21, 24, 30 and 36 months.

Being tested
hepatectomy
Keywords
Liver resection, Laparoscopy
Medical subject headings
Postoperative Complications

What participants receive

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

  • hepatectomyProcedure or surgery

    Resection colorectal liver metastases using a laparoscopic approach or an open approach.

Study groups in NCT04163887
Study groupRoleWhat they receive
laparoscopic liver resectionOtherLaparoscopy allows some surgical procedures to be performed through small incisions that enable the operator to access the abdominal cavity, often at the pubic area, and surgical instruments are introduced through these small incisions. This technique avoids large abdominal incisions and significantly reduces the duration of hospitalization.
Receives: Procedure: hepatectomy
open liver resectionOtherstandard of care
Receives: Procedure: hepatectomy

What is being measured

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

  1. Rate of overall complications using the comprehensive complication Index (CCI)

    CCI is calculated using the burden of postoperative complications weighted with a measure of the severity according to the widely accepted Dindo-Clavien classification of postoperative complications and a dedicated CCI calculator.

    Measured: Within 90 days postoperatively or at any time during hospitalization.

Secondary outcomes (8)

  1. Proportion of patients presenting severe postoperative complications

    Proportion of patients presenting severe postoperative complications rate as defined by the Clavien-Dindo classification ≥ grade 3 (including mortality) between patients treated with laparoscopic liver resection and those treated with open liver surgery

    Measured: Within 90 days postoperatively or at any time during hospitalization.

  2. Rate of conversion from laparoscopy liver resection to open liver surgery

    Conversion is defined as the requirement for laparotomy at any time of the procedure with the exception of the extraction of the resected specimen. Specific data regarding conversion will be noticed from the operative reports. These included the reasons for conversion, the timing of conversion and the type of conversion.

    Measured: during surgery.

  3. Length of hospital stay

    Length of hospital stay and occurrence of unplanned readmission after discharge,assessed by hospitalization reports

    Measured: Within 90 days postoperatively or at any time during hospitalization.

  4. Delay of recovery before resuming professional activities.

    Delay of recovery before resuming professional activities assessed by PQRS (Postoperative Quality Recovery Scale) including nociceptive domain, emotional domain, cognition domain and day-to-day activities at D-1, D1, D7, D30 and D90.

    Measured: Within 90 days postoperatively

  5. Postoperative quality of life using quality of life questionnaries.

    Patient-reported outcome measures were assessed with the validated European Organisation for Research and Treatment of Cancer (EORTC) score questionnaire, EORTC Quality of Life Questionnaire (QLQ) -C30 (version 3.0), and the module dedicated to colorectal liver metastases (EORTC QLQ-LMC21). EQ5D-5L is a standardised measure of health status that provides a simple descriptive profile and a single index value suitable for the economic evaluation of health. It will be used to calculate the QALYs of each enrolled patient, by valuing health.

    Measured: At the inclusion (before surgery), at 1 month postintervention, 3 months, 6 months and then every 6 months during 3 years.

  6. Health economics analysis

    A cost-effectiveness study will be performed and completed by a cost-utility analysis to identify the efficient therapeutic strategy (laparoscopic approach) ompared to the reference (open surgery).

    Only direct costs will be considered for treatments, management of side effects, medical transports, rehabilitation procedures and medical consultations.

    Out of hospital resources are valued from the Social Health Insurance (SHI) tariffs and hospital stays the Diagnosis-Related group (DRG) tariff taking into account additional daily fixed prices for ICU stay, if any.

    Measured: During the full participation period (3 years).

  7. Oncologic quality of the resection using the pathological report.

    Mean surgical margin widths (in millimeters). Percentages of microscopically complete (R0), microscopically incomplete (R1) and macroscopically incomplete (R2) resections as stated in the pathological report.

    Measured: During surgery

  8. Disease-free and overall survival at 3 years.

    1. Percentage of patients with intrahepatic or extrahepatic recurrence three years after the operation.
    2. Median disease-free survival time (in months).
    3. Percentage of patients who died at 1, 2 and 3 years after the procedure.
    4. Median overall survival time (in months).

    Measured: During the full participation period (3 years).

Timeline

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

  1. First posted15 Nov 2019
  2. Study start27 Jan 2021
  3. Primary completion27 Apr 2023 (estimated)
  4. Study completion27 Jan 2026 (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
Model description
Prospective multicenter, open-label and pragmatic, controlled randomized (minimization procedure) superiority trial in 2 parallel groups comparing the rates of 90 days postoperative complications between patients undergoing laparoscopic and open liver resection for colorectal liver metastases.
Masking
None (open label)
Enrolment
340 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04163887
Sponsor's protocol ID
DIG-03-2019
Acronym
METALAP
Status last verified
Feb 2022
First submitted
21 Oct 2019
Last updated
22 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Siegel RL, Miller KD, Jemal A. Cancer statistics, 2015. CA Cancer J Clin. 2015 Jan-Feb;65(1):5-29. doi: 10.3322/caac.21254. Epub 2015 Jan 5.

    PubMed 25559415

  • Manfredi S, Lepage C, Hatem C, Coatmeur O, Faivre J, Bouvier AM. Epidemiology and management of liver metastases from colorectal cancer. Ann Surg. 2006 Aug;244(2):254-9. doi: 10.1097/01.sla.0000217629.94941.cf.

    PubMed 16858188

  • Power DG, Kemeny NE. Role of adjuvant therapy after resection of colorectal cancer liver metastases. J Clin Oncol. 2010 May 1;28(13):2300-9. doi: 10.1200/JCO.2009.26.9340. Epub 2010 Apr 5.

    PubMed 20368552

  • Komatsu S, Scatton O, Goumard C, Sepulveda A, Brustia R, Perdigao F, Soubrane O. Development Process and Technical Aspects of Laparoscopic Hepatectomy: Learning Curve Based on 15 Years of Experience. J Am Coll Surg. 2017 May;224(5):841-850. doi: 10.1016/j.jamcollsurg.2016.12.037. Epub 2017 Jan 20.

    PubMed 28111192

  • Fuks D, Cauchy F, Fteriche S, Nomi T, Schwarz L, Dokmak S, Scatton O, Fusco G, Belghiti J, Gayet B, Soubrane O. Laparoscopy Decreases Pulmonary Complications in Patients Undergoing Major Liver Resection: A Propensity Score Analysis. Ann Surg. 2016 Feb;263(2):353-61. doi: 10.1097/SLA.0000000000001140.

    PubMed 25607769

  • Nomi T, Fuks D, Ogiso S, Nakajima Y, Louvet C, Gayet B. Second and Third Laparoscopic Liver Resection for Patients With Recurrent Colorectal Liver Metastases. Ann Surg. 2016 May;263(5):e68-72. doi: 10.1097/SLA.0000000000001528. No abstract available.

    PubMed 26641255

  • Ciria R, Cherqui D, Geller DA, Briceno J, Wakabayashi G. Comparative Short-term Benefits of Laparoscopic Liver Resection: 9000 Cases and Climbing. Ann Surg. 2016 Apr;263(4):761-77. doi: 10.1097/SLA.0000000000001413.

    PubMed 26700223

  • Hallet J, Sa Cunha A, Cherqui D, Gayet B, Goere D, Bachellier P, Laurent A, Fuks D, Navarro F, Pessaux P; French Colorectal Liver Metastases Working Group, Association Francaise de Chirurgie. Laparoscopic Compared to Open Repeat Hepatectomy for Colorectal Liver Metastases: a Multi-institutional Propensity-Matched Analysis of Short- and Long-Term Outcomes. World J Surg. 2017 Dec;41(12):3189-3198. doi: 10.1007/s00268-017-4119-z.

    PubMed 28717911

  • Fretland AA, Dagenborg VJ, Bjornelv GMW, Kazaryan AM, Kristiansen R, Fagerland MW, Hausken J, Tonnessen TI, Abildgaard A, Barkhatov L, Yaqub S, Rosok BI, Bjornbeth BA, Andersen MH, Flatmark K, Aas E, Edwin B. Laparoscopic Versus Open Resection for Colorectal Liver Metastases: The OSLO-COMET Randomized Controlled Trial. Ann Surg. 2018 Feb;267(2):199-207. doi: 10.1097/SLA.0000000000002353.

    PubMed 28657937

  • Gilg S, Sparrelid E, Isaksson B, Lundell L, Nowak G, Stromberg C. Mortality-related risk factors and long-term survival after 4460 liver resections in Sweden-a population-based study. Langenbecks Arch Surg. 2017 Feb;402(1):105-113. doi: 10.1007/s00423-016-1512-2. Epub 2016 Oct 1.

    PubMed 27695941

  • Cannon RM, Scoggins CR, Callender GG, McMasters KM, Martin RC 2nd. Laparoscopic versus open resection of hepatic colorectal metastases. Surgery. 2012 Oct;152(4):567-73; discussion 573-4. doi: 10.1016/j.surg.2012.07.013. Epub 2012 Sep 1.

    PubMed 22943842

  • Beppu T, Wakabayashi G, Hasegawa K, Gotohda N, Mizuguchi T, Takahashi Y, Hirokawa F, Taniai N, Watanabe M, Katou M, Nagano H, Honda G, Baba H, Kokudo N, Konishi M, Hirata K, Yamamoto M, Uchiyama K, Uchida E, Kusachi S, Kubota K, Mori M, Takahashi K, Kikuchi K, Miyata H, Takahara T, Nakamura M, Kaneko H, Yamaue H, Miyazaki M, Takada T. Long-term and perioperative outcomes of laparoscopic versus open liver resection for colorectal liver metastases with propensity score matching: a multi-institutional Japanese study. J Hepatobiliary Pancreat Sci. 2015 Oct;22(10):711-20. doi: 10.1002/jhbp.261. Epub 2015 May 21.

    PubMed 25902703

  • Adam R, Pascal G, Azoulay D, Tanaka K, Castaing D, Bismuth H. Liver resection for colorectal metastases: the third hepatectomy. Ann Surg. 2003 Dec;238(6):871-83; discussion 883-4. doi: 10.1097/01.sla.0000098112.04758.4e.

    PubMed 14631224

  • Bonjer HJ, Deijen CL, Haglind E; COLOR II Study Group. A Randomized Trial of Laparoscopic versus Open Surgery for Rectal Cancer. N Engl J Med. 2015 Jul 9;373(2):194. doi: 10.1056/NEJMc1505367. No abstract available.

    PubMed 26154803

  • Farges O, Goutte N, Bendersky N, Falissard B; ACHBT-French Hepatectomy Study Group. Incidence and risks of liver resection: an all-inclusive French nationwide study. Ann Surg. 2012 Nov;256(5):697-704; discussion 704-5. doi: 10.1097/SLA.0b013e31827241d5.

    PubMed 23095612

Questions about this trial

What is this clinical trial studying?

A study testing hepatectomy in people with Liver Metastasis Colon Cancer and Postoperative Complications, run by Institut Mutualiste Montsouris at 21 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 4 inclusion and 9 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 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 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?

Results are not available in the source record.

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

Contact Caroline RIX (+33 156616371, caroline.rix@imm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of overall complications using the comprehensive complication Index (CCI) (time frame: Within 90 days postoperatively or at any time during hospitalization.). 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 NCT04163887, which also lists 60 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 22 Feb 2022.

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