Evaluate the benefits, risks and costs of robot-assisted thoraco-laparoscopic esophagectomy as an alternative to open transthoracic esophagectomy as treatment for esophageal cancer.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Oesofagus carcinoom
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint
Overall morbidity: the percentage of overall complications as staded by the
modified Clavien-Dindo classification grade 2 t/m 5.
Secondary outcome
Secondary endpoints:
Individual components of the primary endpoint.
Oncologic outcomes: disease free survival (recurrence) and overall survival 1,
2, 3 and 5 years after surgery.
Major complications
Including: myocardial infarction, anastomotic leakage, chylothorax (chylous
leakage, presence of chylous in thoraxdrains or indication start Vivonex®,
gastric tube necrosis (proven by gastroscopy), pulmonary embolus, deep vein
thrombosis, vocal cord palsy, pneumonia, atelectasis.
Minor complications
Including: wound infections, pleural effusions, delayed gastric emptying
Operation related events:
Operation time is defined as time from incision until closure (minutes) for
each phase of surgery. For the robotic procedure, set up time will de recorded
seperatley. 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:
Pain: Type and dose of used analgesics will be noted during the hospital
admission period.
Visual Analogue Scale (VAS) will be noted at following times: pre-operatively
and the first 10 days after surgery.
Length of ICU-MCU stay (days)
Length of hospital stay (days)
Quality of life
Questionnaires will be required at following times:
SF-36, EORTC QLQ-C30 (Dutch), EORTC OES18 (Dutch) (Appendix 1 & 2)
pre-operative < 5 days, 6 weeks, 6 months and 1, 2 and 3 years post-operatively.
Costs (euro)
Direct general costs, due to extra operating room time andextra instruments.
Indirect costs.
Pathologic examination
The resected specimen will be marked by the surgical team for the position of
lymph node dissection. Evaluation will be performed by an experienced
pathologist using standard protocols (11, 15). Stage grouping will take place
according to the Union Internationale Contre le Cancer (UICC) protocol using
the TNM-7 classification. Exact localization of the lymph nodes is an essential
part of the pathologic examination. The report by the pathologist should be
standardized and contain the following: site of tumor, type and gradation,
extension in the esophageal wall, margins of the resection, extent of resection
(R0, R1 or R2), lymph node status with the number of lymph nodes and
vaso-invasion and perineural growth.
Background summary
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 R0 resection rates and an equal number of dissected lymph
nodes. This is accompanied with markedly reduced blood loss and cardiopulmonary
complications with shorter ICU and hospital stay. Therefore, the robot-assisted
thoraco-laparoscopic esophagectomy is now at a stage that is should be compared
to the current standard of care in a randomized controlled trial.
Study 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
Intervention
112patients 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.
Study burden and risks
Pulmonary complications (pneumonia, atelectasis), cardiac complications (atrial
fibrillation, myocard infarction), anastomotic leakage esophagogastrostomy,
recurrent nerve paralysis, chylothorax, wound infection en perioperative death.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
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 * 80 years
- European Clinical Oncology Group (ECOG) performance status 0,1 or 2
- Written informed consent
Exclusion criteria
- Carcinoma of the cervical and Siewert III gastro-esophageal junction carinoma (GEJ)
- Prior thoracic surgery
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01544790 |
| CCMO | NL35048.041.11 |
| OMON | NL-OMON28386 |