Robot-assisted IVOR-LEWIS Esophagectomy

• Conditions: Clinical or Oncologic Benefits of Robot-assisted IVOR-LEWIS in Esophageal Cancer

• Registration Number: NCT03140189
• Lead Sponsor: Ruijin Hospital

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.

Study Timeline

• Study First Submitted: 2017-05-02
• Study First Submitted QC: 2017-05-02
• Study First Posted: 2017-05-04
• Study Start: 2017-06-14
• Primary Completion: 2019-07-10
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-03
• Last Update Posted: 2022-01-19
• Study Completion: 2024-04-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
rate of major postoperative complications	30 days after surgery

Secondary Outcome Measures

Name	Time	Method
length of hospital stay	within 30 days after surgery
overall survival	3 years after surgery
rate of overall postoperative complications	30 days after surgery
operative time	during the operation
rate of 30-day mortality	30 days after surgery
rate of conversion	during the operation
disease-free survival	3 years after surgery
rate of R0 resection	within 30 days after surgery
number of harvested lymph nodes	within 30 days after surgery

Trial Locations

Locations (1)

Yajie Zhang; 🇨🇳 Shanghai, China