Robot-assisted Thoraco-laparoscopic Esophagectomy Versus Open Transthoracic Esophagectomy

NCT01544790 | Completed Phase 3 DMC

• 2 other identifiers: NL35048.041.1111141
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

This is the first randomized controlled trial designed to compare robot-assisted minimally invasive thoraco-laparoscopic esophagectomy with open transthoracic esophagectomy as surgical treatment for resectable esophageal cancer. If our hypothesis is proved correct, robot-assisted minimally invasive thoraco-laparoscopic esophagectomy will result in a lower percentage of 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).

Conditions

Esophageal Carcinoma; Esophageal Cancer

Keywords

Esophageal carcinoma; Esophageal cancer; Robotic surgery; Esophagectomy; Minimally invasive

Outcome Measures

Primary Outcomes (1)

• Postoperative complications modified Clavien-Dindo classification (MCDC) grade 2 and higher

  The primary outcome of this study is the percentage of overall complications (Grade 2 and higher) as stated by the modified Clavien-Dindo classification of surgical complications (MCDC)

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

Secondary Outcomes (8)

• 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

• (In hospital) Mortality within 30 and 60 days

  Participants will be followed for the duration of hospital stay, an expected average of 2 weeks and within 30 days or 60 days

• R0 resections (%)

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

• 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

Study Arms (2)

Robot-assisted esophagectomy

EXPERIMENTAL

Robot-assisted thoraco-laparoscopic esophagectomy with gastric conduit formation.

Procedure: Esophagectomy

Open transthoracic esophagectomy

ACTIVE COMPARATOR

traditional open transthoracic esophagectomy with gastric conduit formation.

Procedure: Esophagectomy

Interventions

Esophagectomy PROCEDURE

In this monocenter prospective randomized controlled trial, we compare robot-assisted minimally invasive esophagectomy with conventional open transthoracic esophagectomy.

Also known as: robot-assisted minimally invasive esophagectomy, robot-assisted thoraco-laparoscopic esophagectomy

Open transthoracic esophagectomy; Robot-assisted esophagectomy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the intrathoracic esophagus.
• Surgical resectable (T1-4a, N0-3, M0)
• Age ≥ 18 and ≤ 75 years
• European Clinical Oncology Group (ECOG) performance status 0,1 or 2
• Written informed consent

You may not qualify if:

• Carcinoma of the cervical esophagus
• Carcinoma of the gastro-esophageal junction (GEJ) with major tumor in the gastric cardia (Siewert III)
• Prior thoracic surgery at the right hemithorax or thorax trauma (rationale: these patients will undergo open resection)

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

UMC Utrecht

Utrecht, 3584 CX, Netherlands

Location

Related Publications (2)

• 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: 30308612 DERIVED

• van der Sluis PC, Ruurda JP, van der Horst S, Verhage RJ, Besselink MG, Prins MJ, Haverkamp L, Schippers C, Rinkes IH, Joore HC, Ten Kate FJ, Koffijberg H, Kroese CC, van Leeuwen MS, Lolkema MP, Reerink O, Schipper ME, Steenhagen E, Vleggaar FP, Voest EE, Siersema PD, van Hillegersberg R. Robot-assisted minimally invasive thoraco-laparoscopic esophagectomy versus open transthoracic esophagectomy for resectable esophageal cancer, a randomized controlled trial (ROBOT trial). Trials. 2012 Nov 30;13:230. doi: 10.1186/1745-6215-13-230.

  PMID: 23199187 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Esophagectomy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Richard R. van Hillegersberg, MD,PhD

  UMC Utrecht, dept. of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: February 17, 2012
• First Posted: March 6, 2012
• Study Start: April 1, 2012
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: March 26, 2020

Record last verified: 2020-03

Locations

NL (1)