Clinical or Oncologic Benefits of Robot-assisted IVOR-LEWIS in Esophageal Cancer Clinical Trial
— RAILEOfficial title:
Robot- Assisted Ivor-Lewis Esophagectomy for Esophageal Cancer: Short- Term and Long Term Outcomes of a Single-Arm Phase II Trial
| Verified date | January 2022 |
| Source | Ruijin Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Active, not recruiting |
| Enrollment | 51 |
| Est. completion date | April 4, 2024 |
| Est. primary completion date | July 10, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| China | Yajie Zhang | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Ruijin Hospital |
China,
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. — View Citation
Wee JO, Bravo-Iñiguez 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | rate of major postoperative complications | 30 days after surgery | ||
| Secondary | rate of overall postoperative complications | 30 days after surgery | ||
| Secondary | rate of 30-day mortality | 30 days after surgery | ||
| Secondary | operative time | during the operation | ||
| Secondary | rate of conversion | during the operation | ||
| Secondary | length of hospital stay | within 30 days after surgery | ||
| Secondary | rate of R0 resection | within 30 days after surgery | ||
| Secondary | number of harvested lymph nodes | within 30 days after surgery | ||
| Secondary | overall survival | 3 years after surgery | ||
| Secondary | disease-free survival | 3 years after surgery |