Optimalisation of the surgical treatment of esophageal cancer.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pulmonary complications.
Secondary outcome
General morbidity, mortality, operation related events (operation time,
per-operative complications), pain, length of ICU-MCU stay, length of hospital
stay, return to normal diet, quality of life, costs, pathologic examination of
the specimen.
Background summary
Surgery for cancer of the esophagus is considered to be one of the most
extensive and traumatic oncological surgical procedures. Open resection not
only involves a long operation time and large incisions but also necessitates
postoperative care in the intensive care unit, a long in-hospital recovery and
carries a significant risk of morbidity and death. Minimally invasive
esophagectomy can reduce the extensive nature of the required surgery and the
associated risk of morbidity and mortality. Futhermore, reduction of the
postoperative morbidity shortens recovery time. Evidence of the short term
benefits of minimally invasive surgery over open procedures is accumulating.
Faster postoperative recovery, less perioperative complications and a shorter
duration of hospital stay appear to be the main advantages. However, no
prospective trial has been conducted to date. Therefore, the following trial is
proposed for the purpose of improving the efficacy of surgery for esophageal
cancer.
Study objective
Optimalisation of the surgical treatment of esophageal cancer.
Study design
Randomized controlled trial.
Intervention
Traditional three stage (thoracotomy, laparotomy, cervicotomy) esophageal
resection versus minimally invasive three stage (thoracoscopy, laparoscopy,
cervicotomy) transthoracic esophageal resection in prone position in patients
with resectable esophageal cancer.
Study burden and risks
To date the beneficiary effects of minimally invasive resections are reported
in case-series. No randomized trial has been performed comparing minimally
invasive resection with open resection. De results of these case-series do not
show extra risks involving minimally invasive esopgaheal resection. Based on
current literature, no extra risks are foreseen in this first randomized trial.
Furthermore, during evaluations at the outpatient clinic at 6 weeks, 6 months
and 1 year after surgery patients are requested to complete 2 health related
questionnaires.
de boelelaan 1117
1081 HV Amsterdam
NL
de boelelaan 1117
1081 HV Amsterdam
NL
Listed location countries
Age
Inclusion criteria
1. Histologically proven squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the intrathoracic esophagus.
2. Surgical resectable (T1-3, N0-1, M0).
3. Age * 18 and * 75 years.
4. European Clinical Oncology Group (ECOG) performance status 0,1 or 2.
5. Written, informed consent.
Exclusion criteria
1. Cervical and gastro-esophageal junction carcinoma.
2. Prior thoracic surgery.
3. No informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL25587.029.09 |