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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic approach for liver resection of HCC | Experimental |
| |
| laparotomy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopy | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 90 days after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Number of postoperative complications (grade at least 1 according to the Dindo-Clavien classification) within 90 days postoperatively or at any time during hospitalization. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chirurgie Digestive - CHU Amiens | Amiens | France | 80054 | France | ||
| Chirurgie viscérale et digestive - CHU Besançon |
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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.
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|
| Laparotomy | Procedure |
|
|
| 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. | 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. | 90 days after inclusion |
| Occurrence of organ space and superficial surgical site infection (SSI) within 90 days postoperatively or at any time during hospitalization. | 90 days after inclusion |
| Occurrence of abdominal wall complications (abscess, hematoma) within 90 days postoperatively or at any time during hospitalization. | 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. | 90 days after inclusion |
| Occurrence of unplanned reoperation within 90 days postoperatively or at any time during hospitalization. | 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 | 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 | 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 | 1, 3, 5, 7, 30, 60, 90 days after inclusion |
| Mean surgical margin widths (in millimeters). | inclusion |
| Percentages of microscopically complete (R0), microscoically incomplete (R1) and macroscopically incomplete (R2) resections as stated in the pathological report. | 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). | inclusion |
| Overall and disease free survivals. | percentage of hepatocellular carcinoma recurrence percentage of deaths at end of follow-up | 60 month |
| Besançon |
| France |
| 25000 |
| France |
| Chirurgie Hépatologie - Hôpital Beaujon | Clichy | France | 92110 | France |
| Chirurgie Digestive et Hépatobiliaire - Hôpital Henri-Mondor | Créteil | France | 94010 | France |
| Chirurgie Digestive et de l'Urgence - CHU Grenoble | Grenoble | France | 38700 | France |
| Chirurgie Digestive et Transplantations - Hôpital Huriez | Lille | France | 59021 | France |
| Chirurgie Générale, Digestive et de la Transplantation hépatique - Hôpital de la Croix Rousse | Lyon | France | 69317 | France |
| Chirurgie Digestive - CHU Montpellier | Montpellier | France | 34090 | France |
| Chirurgie digestive - Institut Mutualiste Montsouris | Paris | France | 75014 | France |
| Cochin hospital | Paris | France | 75014 | France |
| Chirurgie hépato-biliaire et greffe de foie - La Pitié | Paris | France | 75651 | France |
| Chirurgie viscérale et digestive - CHU Rouen | Rouen | France | 76000 | France |
| Chirurgie hépato-bilio-pancréatique et Transplantation - Hôpital Rangueil | Toulouse | France | 31059 | France |
| Chirurgie digestive Oncologique Endocrinienne et Transplantation hépatique - CHU Tours | Tours | France | 37000 | France |
| Centre hépatobiliaire de transplantation hépatique - Hopital Paul Brousse | Villejuif | France | 94800 | France |
| Chirurgie Digestive - Hôpital La Timone | Marseille | 13005 | France |
| CHU Rennes - Pontchaillou | Rennes | France |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| D007813 | Laparotomy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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