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| Name | Class |
|---|---|
| Grants from Health Ministery National Hospital Clinical Research Program | UNKNOWN |
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Esophageal cancer ranks as the seventh leading cause of cancer globally, with 604,100 new cases, and the sixth leading cause of cancer-related deaths worldwide.
When applicable, surgery is the gold standard treatment for resectable oesophageal-esophagogastric junction cancer. The surgical technique requires both an abdominal approach and a transthoracic approach to resect the esophagus, perform the anastomosis, and allow optimal lymph node removal.
Surgery Historically, esophagectomy was performed entirely through open surgery. This procedure was complex, associated with significant morbidity and mortality, as well as intense acute and chronic postoperative pain.
In this context, thoracic epidural analgesia (TEA) is the gold standard in the management of acute postoperative pain. It allows for opioid sparing and reduces postoperative pulmonary complications.
In order to reduce postoperative pain, facilitate postoperative recovery and limit postoperative complications, particularly respiratory complications, the minimally invasive approach has been proposed for several surgical indications. This principle has led to the development of hybrid esophagectomy, i.e. an abdominal approach by laparoscopy and a thoracic approach by right thoracotomy. An abdominal laparoscopic approach during esophagectomy, even in combination with a right thoracotomy, would therefore limit postoperative complications compared to open surgery.
In parallel to the wider use of hybrid esophagectomy, some teams have demonstrated the feasibility of a totally minimally invasive esophagectomy (TMIE), first video-assisted, then robot-assisted.
The rise of minimally invasive surgery (both hybrid and totally minimally invasive) has led to a decrease in postoperative pain compared to open surgery.
Enhanced recovery after surgery protocols have been developed to improve postoperative recovery and management of acute postoperative pain. In this context, thoracic epidural analgesia TEA may prove counterproductive by inducing arterial hypotension requiring vasopressor drugs, acute urinary retention, and limiting mobilization. Moreover, thoracic epidural analgesia TEA failure occurs in 30% of cases. In minimally invasive surgery, it may be inadequate in half of the patients.
Paravertebral block (PVB) appears as a satisfactory alternative for postoperative analgesia management. In this sense, PVB is recommended for pain management in thoracoscopic lung.
Evidence of the effectiveness and interest of the paravertebral catheter is lacking regarding totally minimally invasive esophageal surgery as most studies demonstrating the benefit of Paravertebral block PVB in esophageal surgery were retrospective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paravertebral catheter group | Experimental |
|
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| Epidural groupe | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paravertebral catheter analgesia | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| The non-inferiority of paravertebral catheter analgesia compared to epidural analgesia in terms of quality of recovery (QoR-15) on postoperative day three in patients undergoing totally minimally invasive esophageal cancer surgery. | Postoperative day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative dose of norepinephrine consumption in milligrams within the first 3 postoperative days. | wtithin 3 postoperative days | |
| Cumulated duration of daily chair mobilization within the first 3 postoperative day | wtithin 3 postoperative days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cédric CIRENEI,, MD | Contact | 03 20 44 59 62 | cedric.cirenei@chru-lille.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Lille | Lille | France |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Epidural group | Procedure |
|
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| Frequency of patients with acute urinary retention leading to urinary catheterization within the first 3 postoperative days. | wtithin 3 postoperative days |
| Change from baseline in pain levels at 3 and 6 months after surgery assessed by using a numerical rating scale. | wtithinat 3 and 6 months |
| Change from baseline in pain levels at 3 and 6 months after surgery assessed by using the Douleur Neuropatique 4 (DN4)score. | wtithinat 3 and 6 months |
| Change from baseline in the quality-of-life level at 3 and 6 months after surgery assessed using th euroQol 5 Dimensions - 5 Levels (Eq-5D- 5L) questionnaire | wtithinat 3 and 6 months |
| Cumulative morphine consumption in milligrams within the first 3 postoperative days. | wtithin 3 postoperative days |
| Pain levels at rest and at mobilization day 1, day 2 and day 3 assessed using a numerical rating scale. | wtithin 3 postoperative days |
| Failure rate of the regional anesthesia technique defined by: -Failure of epidural or paravertebral catheterization -No sensory level after injection of a lidocaine test dose of 30 mg during the cold test | wtithin 3 postoperative days and at 3 and 6 months |
| Number of days in ICU and at hospital | wtithin 3 postoperative days and at 3 and 6 months |
| Frequency of patients with at least one adverse event due to analgesia technique: - Pneumothorax - Hematoma - Catheter insertion site infection | within 3 postoperative days |
| Frequency of patients with at least one pulmonary complication defined according to the Esophagectomy Complication Consensus Group classification during hospital length of stay | within 3 postoperative days |
| Frequency of patients with at least one anastomotic leakage during hospital length of stay according to the the Esophagectomy Complication Consensus Group classification | within 3 postoperative days |
| Frequency of patients with at least one surgical complication during hospital length of stay according to the Esophagectomy Complication Consensus Group classification | within 3 postoperative days |
| Frequency of patients with at least one serious complication defined as a Dindo-Clavien grade III or higher. | within 3 postoperative days |
| Economic evaluation: Incremental net monetary benefit curve over a range of cost-effectiveness thresholds (0-200,000€) | wtithin 6 months |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |