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

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ClinicalTrials.gov Identifier: NCT01544790
Recruitment Status : Completed
First Posted : March 6, 2012
Last Update Posted : April 6, 2017
Sponsor:
Information provided by (Responsible Party):
Richard van Hillegersberg, UMC Utrecht

February 17, 2012
March 6, 2012
April 6, 2017
January 2012
August 2016   (Final data collection date for primary outcome measure)
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 ]
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)
Same as current
Complete list of historical versions of study NCT01544790 on ClinicalTrials.gov Archive Site
  • 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 ]
    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 (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 ]
    (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 ]
    The pathological analysis will be finished within 2 weeks.
  • Operation related events [ Time Frame: Day of surgery, up to 24 hours after surgery. ]
    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 ]
    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. ]
    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. ]
    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 ]
    Direct general costs, due to extra operating room time and extra instruments. Indirect costs, such as reduced ICU or hospital stay.
  • 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 ]
    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 ]
    (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 ]
    The pathological analysis will be finished within 2 weeks.
  • Operation related events [ Time Frame: Day of surgery, up to 24 hours after surgery. ]
    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 ]
    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. ]
    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. ]
    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 ]
    Direct general costs, due to extra operating room time and extra instruments. Indirect costs, such as reduced ICU or hospital stay.
Not Provided
Not Provided
 
Robot-assisted Thoraco-laparoscopic Esophagectomy Versus Open Transthoracic Esophagectomy
Robot-assisted Minimally Invasive Thoraco-laparoscopic Esophagectomy Versus Open Transthoracic Esophagectomy for Resectable Esophageal Cancer. The ROBOT-trial: a Monocenter Randomized Controlled Trial.

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).

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

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Esophageal Carcinoma
  • Esophageal Cancer
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
  • Experimental: Robot-assisted esophagectomy
    Robot-assisted thoraco-laparoscopic esophagectomy with gastric conduit formation.
    Intervention: Procedure: Esophagectomy
  • Active Comparator: Open transthoracic esophagectomy
    traditional open transthoracic esophagectomy with gastric conduit formation.
    Intervention: Procedure: Esophagectomy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
112
Same as current
August 2016
August 2016   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT01544790
NL35048.041.11
11141 ( Registry Identifier: NTR3291 )
Yes
Not Provided
Plan to Share IPD: Undecided
Richard van Hillegersberg, UMC Utrecht
UMC Utrecht
Not Provided
Principal Investigator: Richard R. van Hillegersberg, MD,PhD UMC Utrecht, dept. of Surgery
UMC Utrecht
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP