NCT04652180

Brief Summary

This is a randomized controlled trial designed to compare robot-assisted thoracic approach with open transthoracic esophagectomy (Ivor Lewis technique) as a surgical treatment for resectable esophageal cancer. If our hypothesis is proved correct, robot-assisted thoracic approach will result in a lower percentage of respiratory and overall postoperative complications, lower blood loss, shorter hospital stay, but with at least similar oncologic outcomes and better postoperative quality of life compared with the open transthoracic esophagectomy (current standard).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Nov 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Nov 2020Dec 2026

Study Start

First participant enrolled

November 6, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2020

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 3, 2020

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Expected
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

5.2 years

First QC Date

November 9, 2020

Last Update Submit

February 28, 2023

Conditions

Esophageal CancerEsophageal CarcinomaPostoperative Complications

Outcome Measures

Primary Outcomes (1)

  • Respiratory postoperative complications.

    The primary outcome of this study is the percentage of respiratory complications as stated by the modified Clavien-Dindo classification of surgical complications (MCDC). by means of AME chest approach by robot and thoracotomy (classic surgery).

    Participants will be followed for the duration of hospital stay, an expected average of 2 weeks up to 84+/-3 days from hospital discharge.

Secondary Outcomes (8)

  • Postoperative complications.

    Participants will be followed for the duration of hospital stay, an expected average of 2 weeks up to 84+/-3 days from hospital discharge.

  • Individual components of the primary endpoint (major and minor complications).

    Participants will be followed for the duration of hospital stay, an expected average of 2 weeks up to 84+/-3 days from hospital discharge

  • Postoperative mortality (during hospital stay up to 84+/-3 days after discharge).

    Participants will be followed for the duration of hospital stay, an expected average of 2 weeks up to 84+/-3 days from hospital discharge.

  • Operation related events.

    Day of surgery, up to 24 hours after surgery.

  • Postoperative recovery.

    Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.

  • +3 more secondary outcomes

Study Arms (2)

Robot-assisted thoracic approach in Ivor Lewis esophagectomy

EXPERIMENTAL

Robot-assisted thoracic approach in Ivor Lewis esophagectomy with gastric conduit formation. Abdominal approach will be performed by laparoscopy.

Procedure: Esophagectomy

Open transthoracic approach in Ivor Lewis esophagectomy

ACTIVE COMPARATOR

Traditional open transthoracic esophagectomy with gastric conduit formation. Abdominal approach will be performed by laparoscopy.

Procedure: Esophagectomy

Interventions

EsophagectomyPROCEDURE

In this monocentre randomized controlled trial, we compare robot-assisted thoracic approach with conventional open transthoracic Ivor Lewis esophagectomy.

Also known as: Robot-assisted minimally invasive esophagectomy, Robot-assisted thoracic approach in Ivor Lewis esophagectomy
Open transthoracic approach in Ivor Lewis esophagectomyRobot-assisted thoracic approach in Ivor Lewis esophagectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years.
  • Histologically proven adenocarcinoma, squamous cell carcinoma, undifferentiated carcinoma or carcinoma of the gastro-esophageal junction (GEJ) Siewert I or II.
  • Surgical resectable (T1-4a, N0-3, M0).
  • Childbearing potential women (period between menarche and menopause), pregnancy negative test is mandatory.
  • Written informed consent.

You may not qualify if:

  • Stage IV or GEJ Siewert III esophageal cancer.
  • Contraindication of transthoracic esophagectomy in two fields.
  • Pre- or concomitant cancer or conditions which interferes with the study (e.g. prior thoracic surgery or trauma. Rationale: these patients may undergo open resection).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907., Spain

RECRUITING

Related Publications (8)

  • Stahl M, Mariette C, Haustermans K, Cervantes A, Arnold D; ESMO Guidelines Working Group. Oesophageal cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2013 Oct;24 Suppl 6:vi51-6. doi: 10.1093/annonc/mdt342. No abstract available.

    PMID: 24078662RESULT

  • Inderhees S, Dubecz A. [Hybrid minimally invasive esophagectomy for esophageal cancer-MIRO trial]. Chirurg. 2019 Aug;90(8):677. doi: 10.1007/s00104-019-0983-4. No abstract available. German.

    PMID: 31127335RESULT

  • van der Sluis PC, van der Horst S, May AM, Schippers C, Brosens LAA, Joore HCA, Kroese CC, Haj Mohammad N, Mook S, Vleggaar FP, Borel Rinkes IHM, Ruurda JP, van Hillegersberg R. Robot-assisted Minimally Invasive Thoracolaparoscopic Esophagectomy Versus Open Transthoracic Esophagectomy for Resectable Esophageal Cancer: A Randomized Controlled Trial. Ann Surg. 2019 Apr;269(4):621-630. doi: 10.1097/SLA.0000000000003031.

    PMID: 30308612RESULT

  • Straatman J, van der Wielen N, Cuesta MA, Daams F, Roig Garcia J, Bonavina L, Rosman C, van Berge Henegouwen MI, Gisbertz SS, van der Peet DL. Minimally Invasive Versus Open Esophageal Resection: Three-year Follow-up of the Previously Reported Randomized Controlled Trial: the TIME Trial. Ann Surg. 2017 Aug;266(2):232-236. doi: 10.1097/SLA.0000000000002171.

    PMID: 28187044RESULT

  • Avery KN, Metcalfe C, Berrisford R, Barham CP, Donovan JL, Elliott J, Falk SJ, Goldin R, Hanna G, Hollowood AA, Krysztopik R, Noble S, Sanders G, Streets CG, Titcomb DR, Wheatley T, Blazeby JM. The feasibility of a randomized controlled trial of esophagectomy for esophageal cancer--the ROMIO (Randomized Oesophagectomy: Minimally Invasive or Open) study: protocol for a randomized controlled trial. Trials. 2014 Jun 2;15:200. doi: 10.1186/1745-6215-15-200.

    PMID: 24888266RESULT

  • Brierley RC, Gaunt D, Metcalfe C, Blazeby JM, Blencowe NS, Jepson M, Berrisford RG, Avery KNL, Hollingworth W, Rice CT, Moure-Fernandez A, Wong N, Nicklin J, Skilton A, Boddy A, Byrne JP, Underwood T, Vohra R, Catton JA, Pursnani K, Melhado R, Alkhaffaf B, Krysztopik R, Lamb P, Culliford L, Rogers C, Howes B, Chalmers K, Cousins S, Elliott J, Donovan J, Heys R, Wickens RA, Wilkerson P, Hollowood A, Streets C, Titcomb D, Humphreys ML, Wheatley T, Sanders G, Ariyarathenam A, Kelly J, Noble F, Couper G, Skipworth RJE, Deans C, Ubhi S, Williams R, Bowrey D, Exon D, Turner P, Daya Shetty V, Chaparala R, Akhtar K, Farooq N, Parsons SL, Welch NT, Houlihan RJ, Smith J, Schranz R, Rea N, Cooke J, Williams A, Hindmarsh C, Maitland S, Howie L, Barham CP. Laparoscopically assisted versus open oesophagectomy for patients with oesophageal cancer-the Randomised Oesophagectomy: Minimally Invasive or Open (ROMIO) study: protocol for a randomised controlled trial (RCT). BMJ Open. 2019 Nov 19;9(11):e030907. doi: 10.1136/bmjopen-2019-030907.

    PMID: 31748296RESULT

  • Luketich JD, Pennathur A, Awais O, Levy RM, Keeley S, Shende M, Christie NA, Weksler B, Landreneau RJ, Abbas G, Schuchert MJ, Nason KS. Outcomes after minimally invasive esophagectomy: review of over 1000 patients. Ann Surg. 2012 Jul;256(1):95-103. doi: 10.1097/SLA.0b013e3182590603.

    PMID: 22668811RESULT

  • Pennathur A, Luketich JD, Landreneau RJ, Ward J, Christie NA, Gibson MK, Schuchert M, Cooper K, Land SR, Belani CP. Long-term results of a phase II trial of neoadjuvant chemotherapy followed by esophagectomy for locally advanced esophageal neoplasm. Ann Thorac Surg. 2008 Jun;85(6):1930-6; discussion 1936-7. doi: 10.1016/j.athoracsur.2008.01.097.

    PMID: 18498797RESULT

Related Links

MeSH Terms

Conditions

Esophageal NeoplasmsPostoperative Complications

Interventions

Esophagectomy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Leandre Farran, PhD Surgeon

    STUDY DIRECTOR

Central Study Contacts

Natàlia Cornellà, Surgeon

CONTACT

+34645976556nataliacornellagcirurgia@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Monocentre randomized controlled parallel-group, phase IV, superiority trial. The main purpose is to demonstrate the superiority of robot-assisted thoracic approach over thoracotomy (conventional surgery) in decreasing respiratory and overall complications in Ivor Lewis-type esophagectomy.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD. Department of Esophagogastric Surgery, Hospital Universitari de Bellvitge

Study Record Dates

First Submitted

November 9, 2020

First Posted

December 3, 2020

Study Start

November 6, 2020

Primary Completion

December 30, 2025

Study Completion (Estimated)

December 30, 2026

Last Updated

March 1, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

There is a plan to make IPD and related data dictionaries available.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Immediately following publication and ending 11 months after publication.
Access Criteria
Researches who wish to access the data with a methodological proposal. Types of analyses: to achieve aims in the approved proposal. Mechanism:Proposals should be directed to nataliacornellagcirurgia@gmail.com. To gain access, data requestors will need to sign a data access agreement.

Locations

ES(1)