Clinical trial NCT03140189: Robot-assisted IVOR-LEWIS Esophagectomy
Official title: Robot- Assisted Ivor-Lewis Esophagectomy for Esophageal Cancer: Short- Term and Long Term Outcomes of a Single-Arm Phase II Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Clinical or Oncologic Benefits of Robot-assisted IVOR-LEWIS in Esophageal Cancer
Keywords: Esophageal cancer
Robotic
Ivor-Lewis esophagectomy
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with histologically proven malignancy were candidates for surgical procedures. Operability criteria were defined according to the National Comprehensive Cancer Network guidelines. All patients were within the American Society of Anesthesiologists (ASA) class I to III. In general, neoadjuvant chemoradiotherapy was offered to patients with T2-3 or N1-2 disease.

Brief summary: Minimally invasive esophagectomy (MIE) have become increasingly popular in esophageal cancer. It is generally accepted that comparing to open resections, MIE results in decreased postoperative pain, faster recovery times, and shorter hospital stays with comparable oncologic outcomes. However, MIE poses an important challenge for established thoracic surgeons as it is a difficult technique to become skilled at with an protracted learning curve. Standard laparoscopic and thoracoscopic instruments are rigid and provide a finite freedom of movement with a two dimensional visualization of the operating field. Such a difficulty is increased even more when the Ivor-Lewis esophagectomy with an intrathoracic anastomosis is needed.

Robot- assisted surgical system has opened a new era of minimally invasive surgery. Robot- assisted surgery offers some advantages including high- definition three- dimensional visualization and 7 degrees of freedom with the use of its surgical wrists, motion scaling, and tremor filtration, allowing the surgeon to perform complex operations comfortably in the domain of urinary tract, hepatobiliary and gynecological surgery. Although a robot-assisted thoraco- laparoscopic minimally invasive esophagectomy (RAMIE) was initiated from 2003, the published experience with RAMIE remains small, especially for Ivor- Lewis approaches. The aim of this study was to investigate the short- term and long-term outcomes of RAILE to identify any clinical or oncologic benefits of RAILE in esophageal cancer.

Detailed description: This confirmatory, nonrandomized, single-arm trial (phase II) will be conducted to evaluate short-and long-term outcomes of robot-assisted thoraco- laparoscopic minimally invasive esophagectomy for esophageal cancer. Patients will registered preoperatively. The planned sample size was 51. Preoperative endoscopic biopsy was performed in all patients to confirm the histological diagnosis of esophageal cancer. Staging workup included thorough history and physical examination, esophagogastroduodenoscopy, endoscopic ultrasonography, and integrated positron emission tomography/computed tomography scan. Patients with histologically proven malignancy were candidates for surgical procedures. Operability criteria were defined according to the National Comprehensive Cancer Network guidelines. All patients were within the American Society of Anesthesiologists (ASA) class I to III. In general, neoadjuvant chemoradiotherapy was offered to patients with T2-3 or N1-2 disease. The primary endpoint in the first stage is the short-term postoperative complications, and that in the second stage is overall survival; patients continue to be followed up for this endpoint.

Eligibility criteria: Inclusion Criteria:

1. Patients with histologically proven esophageal malignancy
2. All patients were within the American Society of Anesthesiologists (ASA) class I to III
3. neoadjuvant chemoradiotherapy was offered to patients with T2-3 or N1-2 disease

Exclusion Criteria:

Cancer located at the cervical esophageal Cancer located at the gastroesophageal junction history of surgery in the right thorax

Primary outcomes:
measure: rate of major postoperative complications
timeFrame: 30 days after surgery
Secondary outcomes:
measure: rate of overall postoperative complications
timeFrame: 30 days after surgery
measure: rate of 30-day mortality
timeFrame: 30 days after surgery
measure: operative time
timeFrame: during the operation
measure: rate of conversion
timeFrame: during the operation
measure: length of hospital stay
timeFrame: within 30 days after surgery
measure: rate of R0 resection
timeFrame: within 30 days after surgery
measure: number of harvested lymph nodes
timeFrame: within 30 days after surgery
measure: overall survival
timeFrame: 3 years after surgery
measure: disease-free survival
timeFrame: 3 years after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Yajie Zhang
Study officials:
References:
citation: Wee JO, Bravo-Iniguez CE, Jaklitsch MT. Early Experience of Robot-Assisted Esophagectomy With Circular End-to-End Stapled Anastomosis. Ann Thorac Surg. 2016 Jul;102(1):253-9. doi: 10.1016/j.athoracsur.2016.02.050. Epub 2016 May 4.
citation: Park S, Hwang Y, Lee HJ, Park IK, Kim YT, Kang CH. Comparison of robot-assisted esophagectomy and thoracoscopic esophagectomy in esophageal squamous cell carcinoma. J Thorac Dis. 2016 Oct;8(10):2853-2861. doi: 10.21037/jtd.2016.10.39.