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Gastrointestinal Neoplasms

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Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Esophagectomy performed for esophageal cancer using the da Vinci robotic surgical system

Esophagectomy performed for esophageal cancer using conventional thoracoscopic and laparoscopic techniques

Removal of the esophagus and its draining lymph nodes using robotic surgical instruments

Robotic esophagectomy

Removal of the esophagus and its draining lymph nodes using conventional thoracoscopic and laparoscopic techniques

Thoracolaparoscopic esophagectomy

Shankar Balasubramanian

Bhushan Chittawadagi, MS, DNB

Chinnusamy Palanivelu, MS, MCh

Shankar Balasubramanian, MS, MRCS

Sandeep Sabnis, MS, DNB

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.

Robotic Versus Thoracolaparoscopic Esophagectomy for Esophageal Cancer

Robotic Versus Thoracolaparoscopic Esophagectomy for Carcinoma Esophagus: a Prospective Comparative Study

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.

Intraoperative and post operative adverse events assessed by Clavien Dindo classification system

Duration of stay in ICU following surgery

Length of stay in hospital following surgery

Time taken to complete the surgical procedure recorded in minutes

Amount of blood lost during and within 24 hours of surgery

Need for conversion of the procedure to open or other alternate technique

GEM Hospital & Research Center

Symptoms and General Pathology

Recurrence

Carcinoma, Squamous Cell

Esophageal Squamous Cell Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Patients in the RE group will receive robotic-assisted esophagectomy with standard total two-field lymphadenectomy.

Patients in the VATE group will receive thoracoscopic esophagectomy with standard total two-field lymphadenectomy.

Patients in RE group will receive Robotic-assisted surgery in thoracic phase.

Robot esophagectomy (RE)

Yin-Kai Chao

Yin Kai Chao, MD

The investigators will assess the adequacy of nodal dissection along the recurrent laryngeal nerve performed with robot-assisted versus video-assisted thoracoscopic esophagectomy in patients with esophageal squamous cell carcinoma through a prospective multicentre randomized study design.

Radical lymph node dissection (LND) along the recurrent laryngeal nerve (RLN) is surgically demanding and can be associated with substantial postoperative morbidity. The question as to whether robot-assisted esophagectomy (RE) might be superior to video-assisted thoracoscopic esophagectomy (VATE) for performing LND along the RLN in patients with esophageal squamous cell carcinoma (ESCC) remains open.

The investigators will conduct a multicenter, open-label, randomized controlled trial (termed REVATE) enrolling patients with ESCC scheduled to undergo LND along the RLN. Patients will be randomly assigned to either RE or VATE. The primary outcome measure will be the rate of unsuccessful LND along the left RLN, which will be defined as 1) failure to remove lymph nodes along the left RLN or 2) occurrence of left RLN palsy following LND. Secondary outcomes will include the number of successfully removed RLN nodes, postoperative recovery, length of hospital stay, 30- and 90-day mortality, quality of life, and oncological outcomes.

Robotic-assisted Esophagectomy vs. Video-Assisted Thoracoscopic Esophagectomy(REVATE) Trial

Robotic-assisted Esophagectomy vs. Video-Assisted Thoracoscopic Esophagectomy(REVATE) : a Multicenter Open-label Randomized Controlled Trial

Regardless of the presence of hoarseness, vocal cord function will be assessed by an experienced otolaryngologist using a nexile laryngoscope within one week of surgery. RLN palsy will be classified according to the following variables: site (unilateral versus bilateral); duration (temporary \[i.e., recovering within 6 months\] versus permanent \[i.e. not recovering within 6 months\]); and type of treatment required (type I: no therapy required; type II: injury requiring an elective surgical procedure; type III: injury requiring an urgent surgical procedure)

Post esophagectomy pneumonia is defined according to the Revised Uniform Pneumonia Score which includes temperature\[°C\](Range ≥ 36.1 and ≤ 38.4 =0, ≤ 36.0 and ≥ 38.5=1); leukocyte count \[×1000/uL\](≥ 4.0 and ≤ 11.0=0, \<4.0 or \>11.0=1); and pulmonary radiography(Range No infiltrate=0, Diffused or patchy infiltrate=1, Well-circumscribed infiltrate=2). A sum score of 2 points or higher, of which at least 1 point is assigned because of infiltrative findings on pulmonary radiography, indicates the presence of pneumonia.

Complication grade: modified Clavien-Dindo classification (MCDC) grade 2-4 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, gastric tube necrosis (proven by gastroscopy), pulmonary embolus, deep vein thrombosis.

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

Death occurred during the same hospitalization , within 30 and 90 days after surgery

Microscopically negative proximal/distal and circumferential margin

total surgical time (expressed in minutes)

massive hemorrhage, perforation of other organs

blood loss during surgery (expressed in mL per phase)

Number of patients requiring conversion to thoracotomy and related reasons

expressed in days , calculated from the date of surgery to date of discharge

Need to transfer back from ward to ICU after surgery

From date of surgery until the date of death from any cause

From date of surgery until the date of first documented recurrence

The HADS aims to measure symptoms of anxiety and depression and consists of 14 items,seven items for the anxiety subscale and seven for the depression subscale. The questionnaire responses were analysed in the light of the results of this estimation of the severity of both anxiety and of depression. This enabled a reduction of the number of items in the questionnaire to just seven reflecting anxiety and seven reflecting depression.(Of the seven depression items five reflected aspects of reduction in pleasure response). Each item had been answered by the patient on a four point (0-3) response category so the possible scores ranged from 0 to 21 for anxiety and 0 to 21 for depression. a score of 0 to 7 for either subscale could be regarded as being in the normal range, a score of 11 or higher indicating probable presence ('caseness') of the mood disorder and a score of 8 to 10 being just suggestive of the presence of the respective state.

The EORTC QLQ-C30 incorporates a range of QOL issues in five functional scales (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea/vomiting), a global health/QOL scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The EORTC QLQ-OES18 contains four symptom scales (dysphagia, eating disorders, reflux, and pain) and six single items (difficulty swallowing saliva, choking, dry mouth, taste disorder, cough, and speech-related issues). Each question has four response choices ranging from 1 (not at all) to 4 (very much), except for the global QOL scale, which has seven response options ranging from 1 (very poor) to 7 (excellent). All questionnaire responses are linearly transformed to scores from 0 to 100.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Robotic Versus Thoracolaparoscopic Esophagectomy for Esophageal Cancer	NCT03727126	Esophageal Canc...	Robotic esophag... Thoracolaparosc...	-	GEM Hospital & Research Center
Robotic-assisted Esophagectomy vs. Video-Assisted Thoracoscopic Esophagectomy(REVATE) Trial	NCT03713749	Esophageal Squa...	Robot esophagec...	18 Years - 80 Years	Chang Gung Memorial Hospital
Robotic-assisted Esophagectomy vs. Video-Assisted Thoracoscopic Esophagectomy(REVATE) Trial	NCT03713749	Esophageal Squa...	Robot esophagec...	18 Years - 80 Years	Chang Gung Memorial Hospital

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