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| Name | Class |
|---|---|
| Shanghai Chest Hospital | OTHER |
| Tianjin Medical University Cancer Institute and Hospital | OTHER |
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The investigators will assess the adequacy of nodal dissection along the recurrent laryngeal nerve performed with robot-assisted versus video-assisted thoracoscopic esophagectomy in patients with esophageal squamous cell carcinoma through a prospective multicentre randomized study design.
Radical lymph node dissection (LND) along the recurrent laryngeal nerve (RLN) is surgically demanding and can be associated with substantial postoperative morbidity. The question as to whether robot-assisted esophagectomy (RE) might be superior to video-assisted thoracoscopic esophagectomy (VATE) for performing LND along the RLN in patients with esophageal squamous cell carcinoma (ESCC) remains open.
The investigators will conduct a multicenter, open-label, randomized controlled trial (termed REVATE) enrolling patients with ESCC scheduled to undergo LND along the RLN. Patients will be randomly assigned to either RE or VATE. The primary outcome measure will be the rate of unsuccessful LND along the left RLN, which will be defined as 1) failure to remove lymph nodes along the left RLN or 2) occurrence of left RLN palsy following LND. Secondary outcomes will include the number of successfully removed RLN nodes, postoperative recovery, length of hospital stay, 30- and 90-day mortality, quality of life, and oncological outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot Esophagectomy (RE) | Experimental | Patients in the RE group will receive robotic-assisted esophagectomy with standard total two-field lymphadenectomy. |
|
| Video-assisted thoracoscopic esophagectomy (VATE) | No Intervention | Patients in the VATE group will receive thoracoscopic esophagectomy with standard total two-field lymphadenectomy. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robot esophagectomy (RE) | Device | Patients in RE group will receive Robotic-assisted surgery in thoracic phase. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of unsuccessful LND along the left RLN | Regardless of the presence of hoarseness, vocal cord function will be assessed by an experienced otolaryngologist using a nexile laryngoscope within one week of surgery. RLN palsy will be classified according to the following variables: site (unilateral versus bilateral); duration (temporary [i.e., recovering within 6 months] versus permanent [i.e. not recovering within 6 months]); and type of treatment required (type I: no therapy required; type II: injury requiring an elective surgical procedure; type III: injury requiring an urgent surgical procedure) | Till 6 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| The number of nodes removed along the right and left RLN | number of lymph node removed | The pathological analysis will be finished within 2 weeks. |
| Post esophagectomy pneumonia rate | Post esophagectomy pneumonia is defined according to the Revised Uniform Pneumonia Score which includes temperature[°C](Range ≥ 36.1 and ≤ 38.4 =0, ≤ 36.0 and ≥ 38.5=1); leukocyte count [×1000/uL](≥ 4.0 and ≤ 11.0=0, <4.0 or >11.0=1); and pulmonary radiography(Range No infiltrate=0, Diffused or patchy infiltrate=1, Well-circumscribed infiltrate=2). A sum score of 2 points or higher, of which at least 1 point is assigned because of infiltrative findings on pulmonary radiography, indicates the presence of pneumonia. |
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Inclusion criteria
Exclusion criteria are
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung memorial hospital-Linkou | Recruiting | Taoyuan | 333 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22504922 | Background | Udagawa H, Ueno M, Shinohara H, Haruta S, Kaida S, Nakagawa M, Tsurumaru M. The importance of grouping of lymph node stations and rationale of three-field lymphoadenectomy for thoracic esophageal cancer. J Surg Oncol. 2012 Nov;106(6):742-7. doi: 10.1002/jso.23122. Epub 2012 Apr 13. | |
| 16718401 | Background | Mizutani M, Murakami G, Nawata S, Hitrai I, Kimura W. Anatomy of right recurrent nerve node: why does early metastasis of esophageal cancer occur in it? Surg Radiol Anat. 2006 Aug;28(4):333-8. doi: 10.1007/s00276-006-0115-y. Epub 2006 May 23. |
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| ID | Term |
|---|---|
| D000077277 | Esophageal Squamous Cell Carcinoma |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Duration of hospital stay, an expected average of 2~3 weeks |
| Rate of major postoperative complication | Complication grade: modified Clavien-Dindo classification (MCDC) grade 2-4 Major complications (MCDC grade 2-4) Including: myocardial infarction, anastomotic leakage (clinical or radiologic diagnosis), anastomotic stenosis, chylothorax (chylous leakage, presence of chylous in chest tubes or indication start medium chain triglycerides containing tube feeding, gastric tube necrosis (proven by gastroscopy), pulmonary embolus, deep vein thrombosis. Minor complications (MCDC grade 1) Including: wound infections, pleural effusions, delayed gastric emptying | Duration of hospital stay, an expected average of 2~3 weeks |
| In hospital, 30 day and 90 day mortality | Death occurred during the same hospitalization , within 30 and 90 days after surgery | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks and within 30 days or 90 days |
| R0 resection rate | Microscopically negative proximal/distal and circumferential margin | The pathological analysis will be finished within 2 weeks. |
| Operation time(thoracic phase) | thoracic phase operation time(minutes) | Day of surgery |
| Operation time(abdominal) | abdominal phase operation time(minutes) | Day of surgery |
| Total operation time | total surgical time (expressed in minutes) | Day of surgery |
| Unexpected events and complications occurring during surgery | massive hemorrhage, perforation of other organs | Day of surgery, up to 24 hours after surgery. |
| Blood loss during surgery | blood loss during surgery (expressed in mL per phase) | Day of surgery, up to 24 hours after surgery. |
| Rate of thoracotomy conversion | Number of patients requiring conversion to thoracotomy and related reasons | Day of surgery, up to 24 hours after surgery. |
| Length of mechanical ventilator use after surgery | expressed in minutes | Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks |
| Length of intensive care unit stay after surgery | expressed in hours | Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks |
| Length of postoperative hospital stay | expressed in days , calculated from the date of surgery to date of discharge | Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks |
| Re-intubation rate | Need for re-intubation after extubation | Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks |
| Re-entry ICU rate | Need to transfer back from ward to ICU after surgery | Participants will be followed for the duration of hospital stay, an expected average of 2~3 weeks |
| Overall survival rate | From date of surgery until the date of death from any cause | Assessed 24/36/60 months after surgery |
| Disease free survival rate | From date of surgery until the date of first documented recurrence | Assessed up to 24/36/60 months after surgery |
| Hospital Anxiety and Depression Scale (HADS) | The HADS aims to measure symptoms of anxiety and depression and consists of 14 items,seven items for the anxiety subscale and seven for the depression subscale. The questionnaire responses were analysed in the light of the results of this estimation of the severity of both anxiety and of depression. This enabled a reduction of the number of items in the questionnaire to just seven reflecting anxiety and seven reflecting depression.(Of the seven depression items five reflected aspects of reduction in pleasure response). Each item had been answered by the patient on a four point (0-3) response category so the possible scores ranged from 0 to 21 for anxiety and 0 to 21 for depression. a score of 0 to 7 for either subscale could be regarded as being in the normal range, a score of 11 or higher indicating probable presence ('caseness') of the mood disorder and a score of 8 to 10 being just suggestive of the presence of the respective state. | pre-operative < 5 days and 4 weeks, 3/6 months and yearly up to 5 years post-operatively. |
| European Organisation for Research and Treatment of Cancer(EORTC) QLQ-C30 , QLQ-OES18 | The EORTC QLQ-C30 incorporates a range of QOL issues in five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea/vomiting), a global health/QOL scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The EORTC QLQ-OES18 contains four symptom scales (dysphagia, eating disorders, reflux, and pain) and six single items (difficulty swallowing saliva, choking, dry mouth, taste disorder, cough, and speech-related issues). Each question has four response choices ranging from 1 (not at all) to 4 (very much), except for the global QOL scale, which has seven response options ranging from 1 (very poor) to 7 (excellent). All questionnaire responses are linearly transformed to scores from 0 to 100. | pre-operative < 5 days and 4 weeks, 3/6 months and yearly up to 5 years post-operatively. |
| 26464155 | Background | Sato Y, Kosugi S, Aizawa N, Ishikawa T, Kano Y, Ichikawa H, Hanyu T, Hirashima K, Bamba T, Wakai T. Risk Factors and Clinical Outcomes of Recurrent Laryngeal Nerve Paralysis After Esophagectomy for Thoracic Esophageal Carcinoma. World J Surg. 2016 Jan;40(1):129-36. doi: 10.1007/s00268-015-3261-8. |
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| 22668811 | Background | Luketich JD, Pennathur A, Awais O, Levy RM, Keeley S, Shende M, Christie NA, Weksler B, Landreneau RJ, Abbas G, Schuchert MJ, Nason KS. Outcomes after minimally invasive esophagectomy: review of over 1000 patients. Ann Surg. 2012 Jul;256(1):95-103. doi: 10.1097/SLA.0b013e3182590603. |
| 26196135 | Background | Zhou C, Zhang L, Wang H, Ma X, Shi B, Chen W, He J, Wang K, Liu P, Ren Y. Superiority of Minimally Invasive Oesophagectomy in Reducing In-Hospital Mortality of Patients with Resectable Oesophageal Cancer: A Meta-Analysis. PLoS One. 2015 Jul 21;10(7):e0132889. doi: 10.1371/journal.pone.0132889. eCollection 2015. |
| 22552194 | Background | Biere SS, van Berge Henegouwen MI, Maas KW, Bonavina L, Rosman C, Garcia JR, Gisbertz SS, Klinkenbijl JH, Hollmann MW, de Lange ES, Bonjer HJ, van der Peet DL, Cuesta MA. Minimally invasive versus open oesophagectomy for patients with oesophageal cancer: a multicentre, open-label, randomised controlled trial. Lancet. 2012 May 19;379(9829):1887-92. doi: 10.1016/S0140-6736(12)60516-9. Epub 2012 May 1. |
| 20495981 | Background | Noshiro H, Iwasaki H, Kobayashi K, Uchiyama A, Miyasaka Y, Masatsugu T, Koike K, Miyazaki K. Lymphadenectomy along the left recurrent laryngeal nerve by a minimally invasive esophagectomy in the prone position for thoracic esophageal cancer. Surg Endosc. 2010 Dec;24(12):2965-73. doi: 10.1007/s00464-010-1072-4. Epub 2010 May 22. |
| 25716873 | Background | Park SY, Kim DJ, Yu WS, Jung HS. Robot-assisted thoracoscopic esophagectomy with extensive mediastinal lymphadenectomy: experience with 114 consecutive patients with intrathoracic esophageal cancer. Dis Esophagus. 2016 May;29(4):326-32. doi: 10.1111/dote.12335. Epub 2015 Feb 26. |
| 26023036 | Background | van der Sluis PC, Ruurda JP, Verhage RJ, van der Horst S, Haverkamp L, Siersema PD, Borel Rinkes IH, Ten Kate FJ, van Hillegersberg R. Oncologic Long-Term Results of Robot-Assisted Minimally Invasive Thoraco-Laparoscopic Esophagectomy with Two-Field Lymphadenectomy for Esophageal Cancer. Ann Surg Oncol. 2015 Dec;22 Suppl 3:S1350-6. doi: 10.1245/s10434-015-4544-x. Epub 2015 May 29. |
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| 22392356 | Background | Suda K, Ishida Y, Kawamura Y, Inaba K, Kanaya S, Teramukai S, Satoh S, Uyama I. Robot-assisted thoracoscopic lymphadenectomy along the left recurrent laryngeal nerve for esophageal squamous cell carcinoma in the prone position: technical report and short-term outcomes. World J Surg. 2012 Jul;36(7):1608-16. doi: 10.1007/s00268-012-1538-8. |
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| 19638912 | Background | Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2. |
| 23199187 | Background | van der Sluis PC, Ruurda JP, van der Horst S, Verhage RJ, Besselink MG, Prins MJ, Haverkamp L, Schippers C, Rinkes IH, Joore HC, Ten Kate FJ, Koffijberg H, Kroese CC, van Leeuwen MS, Lolkema MP, Reerink O, Schipper ME, Steenhagen E, Vleggaar FP, Voest EE, Siersema PD, van Hillegersberg R. Robot-assisted minimally invasive thoraco-laparoscopic esophagectomy versus open transthoracic esophagectomy for resectable esophageal cancer, a randomized controlled trial (ROBOT trial). Trials. 2012 Nov 30;13:230. doi: 10.1186/1745-6215-13-230. |
| 29380005 | Background | Li ZG, Zhang XB, Wen YW, Liu YH, Chao YK. Incidence and Predictors of Unsuspected Recurrent Laryngeal Nerve Lymph Node Metastases After Neoadjuvant Chemoradiotherapy in Patients with Esophageal Squamous Cell Carcinoma. World J Surg. 2018 Aug;42(8):2485-2492. doi: 10.1007/s00268-018-4516-y. |
| 29608683 | Background | Chiu CH, Wen YW, Chao YK. Lymph node dissection along the recurrent laryngeal nerves in patients with oesophageal cancer who had undergone chemoradiotherapy: is it safe? Eur J Cardiothorac Surg. 2018 Oct 1;54(4):657-663. doi: 10.1093/ejcts/ezy127. |
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| 26752982 | Background | Tachimori Y, Ozawa S, Numasaki H, Matsubara H, Shinoda M, Toh Y, Udagawa H, Fujishiro M, Oyama T, Uno T; Registration Committee for Esophageal Cancer of the Japan Esophageal Society. Efficacy of lymph node dissection by node zones according to tumor location for esophageal squamous cell carcinoma. Esophagus. 2016;13:1-7. doi: 10.1007/s10388-015-0515-3. Epub 2015 Nov 17. |
| 38960881 | Derived | Chao YK, Li Z, Jiang H, Wen YW, Chiu CH, Li B, Shang X, Fang TJ, Yang Y, Yue J, Zhang X, Zhang C, Liu YH. Multicentre randomized clinical trial on robot-assisted versus video-assisted thoracoscopic oesophagectomy (REVATE trial). Br J Surg. 2024 Jul 2;111(7):znae143. doi: 10.1093/bjs/znae143. |
| 37423873 | Derived | Goense L, van der Sluis PC, van der Horst S, Tagkalos E, Grimminger PP, van Dijk W, Ruurda JP, van Hillegersberg R. Cost analysis of robot-assisted versus open transthoracic esophagectomy for resectable esophageal cancer. Results of the ROBOT randomized clinical trial. Eur J Surg Oncol. 2023 Oct;49(10):106968. doi: 10.1016/j.ejso.2023.06.020. Epub 2023 Jul 1. |
| 31182150 | Derived | Chao YK, Li ZG, Wen YW, Kim DJ, Park SY, Chang YL, van der Sluis PC, Ruurda JP, van Hillegersberg R. Robotic-assisted Esophagectomy vs Video-Assisted Thoracoscopic Esophagectomy (REVATE): study protocol for a randomized controlled trial. Trials. 2019 Jun 10;20(1):346. doi: 10.1186/s13063-019-3441-1. |
| D009369 | Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| D004938 | Esophageal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |