C15.9
Conditions
Interventions
Group 1: Total minimally invasive esophagectomy (MIN-E
either via “classical” minimally invasive laparoscopy + thoracoscopy
or via robotic-assisted minimally invasive esophagectomy [RAMIE] or any combination of the two)
Group 2: Hybrid esophagectomy (HYBRID-E
laparoscopic/ robotic abdominal surgery and open thoracic surgery)
Sponsors
Klinik für Allgemeine, Viszeral- und Transplantationschirurgie Universitätsklinikum Tübingen
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.) Malignant tumor of the thoracic esophagus or the esophagogastric junction considered to be resectable with curative intent via esophagectomy by means of an abdominal and right thoracic approach (Ivor-Lewis procedure) irrespective of neoadjuvant therapy 2.) Suitability of patient for MIN-E and HYBRID-E 3.) Age = 18 years 4.) Ability of subject to understand character and individual consequences of the clinical trial Written informed consent
Exclusion criteria
Exclusion criteria: 1.) Distant metastases 2.) Tumor localization above the azygos vein 3.) History of supraumbilical laparotomy or right thoracotomy within last three years 4.) American Society of Anesthesiologists (ASA)>3 5.) Hepatic cirrhosis Child B/C 6.) Participation in another interventional trial with interference of intervention and/or outcome of this trial 7.) Expected lack of compliance or language problems 8.) Participation in another intervention-trial with interference of intervention and outcome of this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall postoperative morbidity in terms of the comprehensive complication index (CCI) within 30 days after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Procedure-specific morbidity measures: 1. 90-day mortality 2. Rate of re-operations within 90 days related to the index operation. 3. Pulmonary complications within 30 days postoperative according to Esophagectomy Complications Consensus Group (ECCG) definition 4. Esophagoenteric leak from anastomosis, staple line, or localized conduit necrosis within 30 days postoperative according to ECCG definition 5. Conduit necrosis/failure within 30 days postoperative according to ECCG definition 6. Delayed conduit emptying within 30 days postoperative according to ECCG definition 7. Chyle leak according to ECCG definition within 30 days 8. Recurrent nerve injury (vocal cord palsy) according to ECCG definition within 30 days Surgical outcomes measures: 1. Operative time (in minutes; from start of first skin incision until closure of last skin incision) 2. Length of hospital stay (in days; from the day of surgery until discharge) 3. Conversion rate to open surgery Patient-reported Outcome Measures (PROM): 4. Overall pain at rest and during movement (Numeric Rating Scale, NRS 0-10) 5. Assessment of postoperative thoracic pain syndrome measured as pain in the chest at rest and while coughing (NRS, 0-10) at visits 3-10 6. Quality of recovery according to QoR-15 7. Quality of life measured via QLQ-C30 and QLQ-OES18 at baseline Oncological outcome measures: 8. Total lymph node count 9. Rate of microscopic negative resection margin (R0) 10. Disease-free survival (defined as the time from randomization until disease recurrence (local recurrence or metastases) or death from any cause) within 2 years 11. Overall survival (defined as the time between randomization and death from any cause) within 2 years Safety measures: 12. Rate of serious adverse events defined as postoperative complications Clavien-Dindo grade III-V within 90 days. | — |
Countries
Germany
Contacts
Public ContactSilvia Wagner
Surgical Trial Unit Tübingen (STU)
Outcome results
None listed