- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03140189
Robot-assisted IVOR-LEWIS Esophagectomy (RAILE)
Robot- Assisted Ivor-Lewis Esophagectomy for Esophageal Cancer: Short- Term and Long Term Outcomes of a Single-Arm Phase II Trial
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.
Studieöversikt
Status
Detaljerad beskrivning
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
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Shanghai, Kina, 200000
- Yajie Zhang
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Patients with histologically proven esophageal malignancy
- All patients were within the American Society of Anesthesiologists (ASA) class I to III
- 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
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
rate of major postoperative complications
Tidsram: 30 days after surgery
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30 days after surgery
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
rate of overall postoperative complications
Tidsram: 30 days after surgery
|
30 days after surgery
|
rate of 30-day mortality
Tidsram: 30 days after surgery
|
30 days after surgery
|
operative time
Tidsram: during the operation
|
during the operation
|
rate of conversion
Tidsram: during the operation
|
during the operation
|
length of hospital stay
Tidsram: within 30 days after surgery
|
within 30 days after surgery
|
rate of R0 resection
Tidsram: within 30 days after surgery
|
within 30 days after surgery
|
number of harvested lymph nodes
Tidsram: within 30 days after surgery
|
within 30 days after surgery
|
overall survival
Tidsram: 3 years after surgery
|
3 years after surgery
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disease-free survival
Tidsram: 3 years after surgery
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3 years after surgery
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Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Allmänna publikationer
- 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.
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RTS-003
Läkemedels- och apparatinformation, studiedokument
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