- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
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Shanghai, Kina, 200000
- Yajie Zhang
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
rate of major postoperative complications
Tidsramme: 30 days after surgery
|
30 days after surgery
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
rate of overall postoperative complications
Tidsramme: 30 days after surgery
|
30 days after surgery
|
rate of 30-day mortality
Tidsramme: 30 days after surgery
|
30 days after surgery
|
operative time
Tidsramme: during the operation
|
during the operation
|
rate of conversion
Tidsramme: during the operation
|
during the operation
|
length of hospital stay
Tidsramme: within 30 days after surgery
|
within 30 days after surgery
|
rate of R0 resection
Tidsramme: within 30 days after surgery
|
within 30 days after surgery
|
number of harvested lymph nodes
Tidsramme: within 30 days after surgery
|
within 30 days after surgery
|
overall survival
Tidsramme: 3 years after surgery
|
3 years after surgery
|
disease-free survival
Tidsramme: 3 years after surgery
|
3 years after surgery
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RTS-003
Legemiddel- og utstyrsinformasjon, studiedokumenter
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