Robot-assisted Thoraco-laparoscopic Esophagectomy Versus Open Transthoracic Esophagectomy
NCT ID: NCT01544790
Last Updated: 2020-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
112 participants
INTERVENTIONAL
2012-04-30
2016-08-31
Brief Summary
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If our hypothesis is proved correct, robot-assisted minimally invasive thoraco-laparoscopic esophagectomy will result in a lower percentage of postoperative complications, lower blood loss, shorter hospital stay, but with at least similar oncologic outcomes and better postoperative quality of life compared with the open transthoracic esophagectomy (current standard).
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Detailed Description
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Objective: Evaluate the benefits, risks and costs of robot-assisted thoraco-laparoscopic esophagectomy as an alternative to open transthoracic esophagectomy as treatment for esophageal cancer.
Study design: Randomized controlled parallel-group superiority trial Study population: Patients (age ≥ 18 and ≤ 75 jaar) with histologically proven surgically resectable (cT1-4a, N0-3, M0) squamous cell carcinoma, adenocarcinoma or undifferentiated esophageal carcinoma of the intrathoracic esophagus with European Clinical Oncology Group (ECOG) status 0, 1 or 2.
Intervention: 112 patients will be randomly allocated to either A) robot-assisted thoraco-laparoscopic esophagectomy (n=56) or B) open transthoracic esophagectomy (n=56).
Patients will receive the following interventions:
Group A. Robot-assisted thoraco-laparoscopic esophagectomy, with gastric conduit formation.
Group B. Open transthoracic esophagectomy, with gastric conduit formation.
Main study parameters/endpoints: Primary outcome is the percentage of overall complications (Grade 2 and higher) as stated by the modified Clavien-Dindo classification (MCDC).
Secondary outcomes are individual components of the primary endpoint (major and minor complications), (in hospital) mortality within 30 and 60 days, R0 resections, operation related events, postoperative recovery, oncologic outcomes, cost-effectiveness and quality of life.
Follow-up: 60 months after randomization
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Robot-assisted esophagectomy
Robot-assisted thoraco-laparoscopic esophagectomy with gastric conduit formation.
Esophagectomy
In this monocenter prospective randomized controlled trial, we compare robot-assisted minimally invasive esophagectomy with conventional open transthoracic esophagectomy.
Open transthoracic esophagectomy
traditional open transthoracic esophagectomy with gastric conduit formation.
Esophagectomy
In this monocenter prospective randomized controlled trial, we compare robot-assisted minimally invasive esophagectomy with conventional open transthoracic esophagectomy.
Interventions
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Esophagectomy
In this monocenter prospective randomized controlled trial, we compare robot-assisted minimally invasive esophagectomy with conventional open transthoracic esophagectomy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Surgical resectable (T1-4a, N0-3, M0)
* Age ≥ 18 and ≤ 75 years
* European Clinical Oncology Group (ECOG) performance status 0,1 or 2
* Written informed consent
Exclusion Criteria
* Carcinoma of the gastro-esophageal junction (GEJ) with major tumor in the gastric cardia (Siewert III)
* Prior thoracic surgery at the right hemithorax or thorax trauma (rationale: these patients will undergo open resection)
18 Years
75 Years
ALL
No
Sponsors
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UMC Utrecht
OTHER
Responsible Party
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Richard van Hillegersberg
Prof.
Principal Investigators
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Richard R. van Hillegersberg, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
UMC Utrecht, dept. of Surgery
Locations
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UMC Utrecht
Utrecht, , Netherlands
Countries
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References
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van der Sluis PC, van der Horst S, May AM, Schippers C, Brosens LAA, Joore HCA, Kroese CC, Haj Mohammad N, Mook S, Vleggaar FP, Borel Rinkes IHM, Ruurda JP, van Hillegersberg R. Robot-assisted Minimally Invasive Thoracolaparoscopic Esophagectomy Versus Open Transthoracic Esophagectomy for Resectable Esophageal Cancer: A Randomized Controlled Trial. Ann Surg. 2019 Apr;269(4):621-630. doi: 10.1097/SLA.0000000000003031.
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.
Other Identifiers
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11141
Identifier Type: REGISTRY
Identifier Source: secondary_id
NL35048.041.11
Identifier Type: -
Identifier Source: org_study_id
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