Robot-assisted minimally invasive thoraco-laparoscopic esophagectomy versus open transthoracic esophagectomy for resectable esophageal cancer, a randomized controlled trial (ROBOT trial)
<p>Abstract</p> <p>Background</p> <p>For esophageal cancer patients, radical esophagolymphadenectomy is the cornerstone of multimodality treatment with curative intent. Transthoracic esophagectomy is the preferred surgical approach worldwide allowing for <it>en-bl...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMC
2012-11-01
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| Series: | Trials |
| Online Access: | http://www.trialsjournal.com/content/13/1/230 |
| _version_ | 1818787035066925056 |
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| author | van der Sluis Pieter C Ruurda Jelle P van der Horst Sylvia Verhage Roy JJ Besselink Marc GH Prins Margriet JD Haverkamp Leonie Schippers Carlo Rinkes Inne HM Borel Joore Hans CA ten Kate Fiebo JW Koffijberg Hendrik Kroese Christiaan C van Leeuwen Maarten S Lolkema Martijn PJK Reerink Onne Schipper Marguerite EI Steenhagen Elles Vleggaar Frank P Voest Emile E Siersema Peter D van Hillegersberg Richard |
| author_facet | van der Sluis Pieter C Ruurda Jelle P van der Horst Sylvia Verhage Roy JJ Besselink Marc GH Prins Margriet JD Haverkamp Leonie Schippers Carlo Rinkes Inne HM Borel Joore Hans CA ten Kate Fiebo JW Koffijberg Hendrik Kroese Christiaan C van Leeuwen Maarten S Lolkema Martijn PJK Reerink Onne Schipper Marguerite EI Steenhagen Elles Vleggaar Frank P Voest Emile E Siersema Peter D van Hillegersberg Richard |
| author_sort | van der Sluis Pieter C |
| collection | DOAJ |
| description | <p>Abstract</p> <p>Background</p> <p>For esophageal cancer patients, radical esophagolymphadenectomy is the cornerstone of multimodality treatment with curative intent. Transthoracic esophagectomy is the preferred surgical approach worldwide allowing for <it>en-bloc</it> resection of the tumor with the surrounding lymph nodes. However, the percentage of cardiopulmonary complications associated with the transthoracic approach is high (50 to 70%).</p> <p>Recent studies have shown that robot-assisted minimally invasive thoraco-laparoscopic esophagectomy (RATE) is at least equivalent to the open transthoracic approach for esophageal cancer in terms of short-term oncological outcomes. RATE was accompanied with reduced blood loss, shorter ICU stay and improved lymph node retrieval compared with open esophagectomy, and the pulmonary complication rate, hospital stay and perioperative mortality were comparable. The objective is to evaluate the efficacy, risks, quality of life and cost-effectiveness of RATE as an alternative to open transthoracic esophagectomy for treatment of esophageal cancer.</p> <p>Methods/design</p> <p>This is an investigator-initiated and investigator-driven monocenter randomized controlled parallel-group, superiority trial. All adult patients (age ≥18 and ≤80 years) with histologically proven, surgically resectable (cT1-4a, N0-3, M0) esophageal carcinoma of the intrathoracic esophagus and with European Clinical Oncology Group performance status 0, 1 or 2 will be assessed for eligibility and included after obtaining informed consent. Patients (<it>n</it> = 112) with resectable esophageal cancer are randomized in the outpatient department to either RATE (<it>n</it> = 56) or open three-stage transthoracic esophageal resection (<it>n</it> = 56). The primary outcome of this study is the percentage of overall complications (grade 2 and higher) as stated by the modified Clavien–Dindo classification of surgical complications.</p> <p>Discussion</p> <p>This is the first randomized controlled trial designed to compare RATE with open transthoracic esophagectomy as surgical treatment for resectable esophageal cancer. If our hypothesis is proven correct, RATE will result in a lower percentage of postoperative complications, lower blood loss, and shorter hospital stay, but with at least similar oncologic outcomes and better postoperative quality of life compared with open transthoracic esophagectomy. The study started in January 2012. Follow-up will be 5 years. Short-term results will be analyzed and published after discharge of the last randomized patient.</p> <p>Trial registration</p> <p>Dutch trial register: NTR3291 ClinicalTrial.gov: NCT01544790</p> |
| first_indexed | 2024-12-18T14:01:22Z |
| format | Article |
| id | doaj.art-ea3857fd87c74f9590931131e983e3ca |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-18T14:01:22Z |
| publishDate | 2012-11-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-ea3857fd87c74f9590931131e983e3ca2022-12-21T21:05:20ZengBMCTrials1745-62152012-11-0113123010.1186/1745-6215-13-230Robot-assisted minimally invasive thoraco-laparoscopic esophagectomy versus open transthoracic esophagectomy for resectable esophageal cancer, a randomized controlled trial (ROBOT trial)van der Sluis Pieter CRuurda Jelle Pvan der Horst SylviaVerhage Roy JJBesselink Marc GHPrins Margriet JDHaverkamp LeonieSchippers CarloRinkes Inne HM BorelJoore Hans CAten Kate Fiebo JWKoffijberg HendrikKroese Christiaan Cvan Leeuwen Maarten SLolkema Martijn PJKReerink OnneSchipper Marguerite EISteenhagen EllesVleggaar Frank PVoest Emile ESiersema Peter Dvan Hillegersberg Richard<p>Abstract</p> <p>Background</p> <p>For esophageal cancer patients, radical esophagolymphadenectomy is the cornerstone of multimodality treatment with curative intent. Transthoracic esophagectomy is the preferred surgical approach worldwide allowing for <it>en-bloc</it> resection of the tumor with the surrounding lymph nodes. However, the percentage of cardiopulmonary complications associated with the transthoracic approach is high (50 to 70%).</p> <p>Recent studies have shown that robot-assisted minimally invasive thoraco-laparoscopic esophagectomy (RATE) is at least equivalent to the open transthoracic approach for esophageal cancer in terms of short-term oncological outcomes. RATE was accompanied with reduced blood loss, shorter ICU stay and improved lymph node retrieval compared with open esophagectomy, and the pulmonary complication rate, hospital stay and perioperative mortality were comparable. The objective is to evaluate the efficacy, risks, quality of life and cost-effectiveness of RATE as an alternative to open transthoracic esophagectomy for treatment of esophageal cancer.</p> <p>Methods/design</p> <p>This is an investigator-initiated and investigator-driven monocenter randomized controlled parallel-group, superiority trial. All adult patients (age ≥18 and ≤80 years) with histologically proven, surgically resectable (cT1-4a, N0-3, M0) esophageal carcinoma of the intrathoracic esophagus and with European Clinical Oncology Group performance status 0, 1 or 2 will be assessed for eligibility and included after obtaining informed consent. Patients (<it>n</it> = 112) with resectable esophageal cancer are randomized in the outpatient department to either RATE (<it>n</it> = 56) or open three-stage transthoracic esophageal resection (<it>n</it> = 56). The primary outcome of this study is the percentage of overall complications (grade 2 and higher) as stated by the modified Clavien–Dindo classification of surgical complications.</p> <p>Discussion</p> <p>This is the first randomized controlled trial designed to compare RATE with open transthoracic esophagectomy as surgical treatment for resectable esophageal cancer. If our hypothesis is proven correct, RATE will result in a lower percentage of postoperative complications, lower blood loss, and shorter hospital stay, but with at least similar oncologic outcomes and better postoperative quality of life compared with open transthoracic esophagectomy. The study started in January 2012. Follow-up will be 5 years. Short-term results will be analyzed and published after discharge of the last randomized patient.</p> <p>Trial registration</p> <p>Dutch trial register: NTR3291 ClinicalTrial.gov: NCT01544790</p>http://www.trialsjournal.com/content/13/1/230 |
| spellingShingle | van der Sluis Pieter C Ruurda Jelle P van der Horst Sylvia Verhage Roy JJ Besselink Marc GH Prins Margriet JD Haverkamp Leonie Schippers Carlo Rinkes Inne HM Borel Joore Hans CA ten Kate Fiebo JW Koffijberg Hendrik Kroese Christiaan C van Leeuwen Maarten S Lolkema Martijn PJK Reerink Onne Schipper Marguerite EI Steenhagen Elles Vleggaar Frank P Voest Emile E Siersema Peter D van Hillegersberg Richard Robot-assisted minimally invasive thoraco-laparoscopic esophagectomy versus open transthoracic esophagectomy for resectable esophageal cancer, a randomized controlled trial (ROBOT trial) Trials |
| title | Robot-assisted minimally invasive thoraco-laparoscopic esophagectomy versus open transthoracic esophagectomy for resectable esophageal cancer, a randomized controlled trial (ROBOT trial) |
| title_full | Robot-assisted minimally invasive thoraco-laparoscopic esophagectomy versus open transthoracic esophagectomy for resectable esophageal cancer, a randomized controlled trial (ROBOT trial) |
| title_fullStr | Robot-assisted minimally invasive thoraco-laparoscopic esophagectomy versus open transthoracic esophagectomy for resectable esophageal cancer, a randomized controlled trial (ROBOT trial) |
| title_full_unstemmed | Robot-assisted minimally invasive thoraco-laparoscopic esophagectomy versus open transthoracic esophagectomy for resectable esophageal cancer, a randomized controlled trial (ROBOT trial) |
| title_short | Robot-assisted minimally invasive thoraco-laparoscopic esophagectomy versus open transthoracic esophagectomy for resectable esophageal cancer, a randomized controlled trial (ROBOT trial) |
| title_sort | robot assisted minimally invasive thoraco laparoscopic esophagectomy versus open transthoracic esophagectomy for resectable esophageal cancer a randomized controlled trial robot trial |
| url | http://www.trialsjournal.com/content/13/1/230 |
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