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Robot-assisted Thoraco-laparoscopic Esophagectomy Versus Open Transthoracic Esophagectomy (ROBOT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by UMC Utrecht
Sponsor:
Information provided by (Responsible Party):
R. van Hillegersberg, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT01544790
First received: February 17, 2012
Last updated: October 7, 2014
Last verified: October 2014
  Purpose

This is the first randomized controlled trial designed to compare robot-assisted minimally invasive thoraco-laparoscopic esophagectomy with open transthoracic esophagectomy as surgical treatment for resectable esophageal cancer.

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).


Condition Intervention Phase
Esophageal Carcinoma
Esophageal Cancer
Procedure: Esophagectomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Robot-assisted Minimally Invasive Thoraco-laparoscopic Esophagectomy Versus Open Transthoracic Esophagectomy for Resectable Esophageal Cancer. The ROBOT-trial: a Monocenter Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Postoperative complications modified Clavien-Dindo classification (MCDC) grade 2 and higher [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: Yes ]
    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 (MCDC)


Secondary Outcome Measures:
  • Individual components of the primary endpoint (major and minor complications) [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: Yes ]

    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 triglycerids containing tube feeding (Vivonex®), gastric tube necrosis (proven by gastroscopy), pulmonary embolus, deep vein thrombosis, vocal cord palsy or paralysis.

    Minor complications (MCDC grade 1) Including: wound infections, pleural effusions, delayed gastric emptying


  • (In hospital) Mortality within 30 and 60 days [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks and within 30 days or 60 days ] [ Designated as safety issue: Yes ]
    (In hospital) mortality and mortality within 30 and 60 days will be reported. The cause of death and the results of the autopsy report will be noted.

  • R0 resections (%) [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: No ]
    The pathological analysis will be finished within 2 weeks.

  • Operation related events [ Time Frame: Day of surgery, up to 24 hours after surgery. ] [ Designated as safety issue: Yes ]

    Operation time is defined as time from incision until closure (minutes) for both the thoracic and the abdominal phase of the procedure. For the robotic procedure, set up time will be recorded separately. Unexpected events and complications occurring during the operation will be recorded (e.g. massive hemorrhage, perforation of other organs).

    Blood loss during operation (ml, per phase). In case of conversion to thoracotomy or laparotomy the reason for conversion has to be explained (absolute numbers/percentage).


  • Postoperative recovery [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: Yes ]

    Pain: Type and dose of used analgesics will be noted during the hospital admission period.

    Visual Analogue Scale (VAS) for pain will be noted at following times: pre-operatively and the first 10 days after surgery and a fixed periods during follow up (6 weeks, 6 months and yearly post-operatively up to 5 years).

    Length of intensive care unit (ICU) - medium care unit (MCU) stay (days). Length of hospital stay (days).


  • Oncologic outcomes [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months after surgery. ] [ Designated as safety issue: Yes ]
    2, 3 and 5 year disease free and overall survival

  • Quality of life [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months after surgery. ] [ Designated as safety issue: No ]

    Questionnaires will be required at following times:

    SF-36, EORTC QLQ-C30 (Dutch), EORTC OES18 (Dutch) and EQ-5D (Appendix 1 & 2) pre-operative < 5 days and 6 weeks, 6 months and yearly up to 5 years post-operatively.


  • Costs (euro) [ Time Frame: 5 years follow up ] [ Designated as safety issue: No ]
    Direct general costs, due to extra operating room time and extra instruments. Indirect costs, such as reduced ICU or hospital stay.


Estimated Enrollment: 112
Study Start Date: January 2012
Estimated Study Completion Date: January 2021
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Robot-assisted esophagectomy
Robot-assisted thoraco-laparoscopic esophagectomy with gastric conduit formation.
Procedure: Esophagectomy
In this monocenter prospective randomized controlled trial, we compare robot-assisted minimally invasive esophagectomy with conventional open transthoracic esophagectomy.
Other Names:
  • robot-assisted minimally invasive esophagectomy
  • robot-assisted thoraco-laparoscopic esophagectomy
Active Comparator: Open transthoracic esophagectomy
traditional open transthoracic esophagectomy with gastric conduit formation.
Procedure: Esophagectomy
In this monocenter prospective randomized controlled trial, we compare robot-assisted minimally invasive esophagectomy with conventional open transthoracic esophagectomy.
Other Names:
  • robot-assisted minimally invasive esophagectomy
  • robot-assisted thoraco-laparoscopic esophagectomy

Detailed Description:

Rationale: As stated in the 2010 revised Dutch esophageal carcinoma guidelines, the golden standard for surgical treatment of esophageal carcinoma is open transthoracic esophagectomy. Recent evidence suggests that robot-assisted thoraco-laparoscopic esophagectomy using the Da Vinci ® robot can provide an extensive resection, with possibly better or at least equal radical (R0) resection rates and an equal number of dissected lymph nodes. This is accompanied with markedly reduced blood loss and reduction of overall complications with shorter intensive care unit (ICU) and hospital stay. Therefore, the robot-assisted thoraco-laparoscopic esophagectomy is now at a stage that it should be compared to the current standard of care in a randomized controlled trial.

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically proven squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the intrathoracic esophagus.
  • 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 cervical esophagus
  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01544790

Contacts
Contact: Richard van Hillegersberg, MD, PhD +3188-7558074 r.vanhillegersberg@umcutrecht.nl
Contact: Pietrer C. van der Sluis, MD, Msc. +3188-7558074 P.c.vandersluis-2@umcutrecht.nl

Locations
Netherlands
UMC Utrecht Recruiting
Utrecht, Netherlands, 3584 CX
Contact: Richard van Hillegersberg, MD, PhD    +3188-7558074    r.vanhillegersberg@umcutrecht.nl   
Contact: Pieter C. van der Sluis, MD, Msc.    +3188-7558074    p.c.vandersluis-2@umcutrecht.nl   
Principal Investigator: Richard van Hillegersberg, MD, PhD         
Sub-Investigator: Jelle P. Ruurda, MD, PhD         
Sub-Investigator: Pieter C. van der Sluis, MD, Msc.         
Sponsors and Collaborators
UMC Utrecht
Investigators
Principal Investigator: Richard R. van Hillegersberg, MD,PhD UMC Utrecht, dept. of Surgery
  More Information

No publications provided by UMC Utrecht

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: R. van Hillegersberg, Prof., UMC Utrecht
ClinicalTrials.gov Identifier: NCT01544790     History of Changes
Other Study ID Numbers: NL35048.041.11, 11141
Study First Received: February 17, 2012
Last Updated: October 7, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:
Esophageal carcinoma
Esophageal cancer
Robotic surgery
Esophagectomy
Minimally invasive

Additional relevant MeSH terms:
Esophageal Diseases
Carcinoma
Esophageal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 24, 2014