Esophageal Cancer
Conditions
Keywords
Esophagectomy, Robotic esophagectomy, Laparoscopic esophagectomy, Minimally invasive esophagectomy, Ivor Lewis esophagectomy, McKeown's esophagectomy
Brief summary
Esophageal cancer is a debilitating condition. The treatment involved is complex requiring a combination of chemotherapy and surgery in most cases. Complete removal of the tumor and the adjacent lymph nodes is of utmost importance in improving the survival. Lymph node yield following surgery helps in proper staging of the disease and is an important prognosticating variable. It is hypothesized that the lymph node yield following robotic esophagectomy is higher than that following thoracolaparoscopic esophagectomy. The study aims to compare the short term oncological outcomes following robotic esophagectomy and thoracolaparoscopic esophagectomy for carcinoma esophagus.
Interventions
PROCEDURERobotic esophagectomy
Removal of the esophagus and its draining lymph nodes using robotic surgical instruments
PROCEDUREThoracolaparoscopic esophagectomy
Removal of the esophagus and its draining lymph nodes using conventional thoracoscopic and laparoscopic techniques
Sponsors
GEM Hospital & Research Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Resectable esophageal carcinoma, either squamous cell carcinoma or adenocarcinoma in the middle or lower part the esophagus
Exclusion criteria
* American Society of Anesthesiologists (ASA) class 4 and above * Esophagectomy for other non-malignant conditions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lymph node yield | 7 days after Index Surgery | Total number of lymph nodes harvested |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications | Up to 90 days after surgery | Intraoperative and post operative adverse events assessed by Clavien Dindo classification system |
| ICU stay | During index admission or within 30 days after surgery | Duration of stay in ICU following surgery |
| Hospital stay | During index admission or re admission within 30 days | Length of stay in hospital following surgery |
| Surgical margin status | 7 days after Index Surgery | The proximal, distal and circumferential surgical margins will be assessed by pathological evaluation for the presence of tumor and will be assigned an R category as defined by the College of American Pathologists. R0 would indicate no evidence of residual tumor. Presence of microscopic tumor at margins would be designated as R1 whereas the presence of macroscopically visible tumor at margins would be designated as R2. |
| Duration of surgery | 1 day after surgery | Time taken to complete the surgical procedure recorded in minutes |
| Blood loss | During surgery and up to 24 hours after index surgery | Amount of blood lost during and within 24 hours of surgery |
| Conversion rate | 1 day after surgery | Need for conversion of the procedure to open or other alternate technique |
| Mortality | During index admission or within 90 days following surgery | Death following surgery |
Countries
India
Contacts
Primary ContactShankar Balasubramanian
Outcome results
None listed