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Procedure

RAMIE vs OTE for Esophageal Cancer (RAMIE vs OTE Trial)

N/A

Recruiting

Research Sponsored by St. Joseph's Healthcare Hamilton

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 or older

Clinical Stage I, II, or III esophageal cancer, who are candidates for surgery after discussion in multidisciplinary tumor board

Must not have

Women who are currently pregnant or are breastfeeding; or women of childbearing potential who are not currently taking adequate birth control

Clinical Stage IV esophageal cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial will help to build the infrastructure for introducing a less invasive and more effective surgery for esophageal cancer in Canada, as well as lay the foundations for a future study comparing the two surgeries.

Who is the study for?

This trial is for adults with Stage I, II, or III esophageal cancer who are eligible for surgery. It's not open to pregnant or breastfeeding women, those not using birth control, people allergic to ICG/sodium iodide/iodine, or anyone unsuitable for minimally invasive surgery.

What is being tested?

The study compares two surgical methods for esophageal cancer: a new robotic-assisted technique (RAMIE) and the standard open surgery (OTE). RAMIE uses advanced robotics aiming to reduce complications and recovery time.

What are the potential side effects?

Potential side effects of surgeries may include pain at the incision site, risk of infection, bleeding, breathing difficulties post-operation and longer-term issues like difficulty swallowing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My esophageal cancer is in an early stage and I am a candidate for surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant, breastfeeding, and if able to bear children, I am using effective birth control.

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My esophageal cancer is in stage IV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, postoperative day 1, 3-weeks postoperative, 12-weeks postoperative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, postoperative day 1, 3-weeks postoperative, 12-weeks postoperative

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, postoperative day 1, 3-weeks postoperative, 12-weeks postoperative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The feasibility of a large-scale RCT, as measured by the number of patients willing to participate in the study.

Secondary study objectives

Conversion from RAMIE to OTE

Length of Operation

Length of Stay (LOS)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: NIF-Guided RAMIE using ICG Dye (Experimental Arm)Experimental Treatment1 Intervention

The patient will undergo NIF-guided RAMIE using ICG dye using the standard Ivor-Lewis approach. This will be a two-stage operation involving a first stage through a 5-port robotic approach through the abdomen to achieve a proximal gastrectomy and D2 nodal dissection. A feeding jejunostomy would not be inserted, as per the enhanced recovery pathway for esophagectomy. In addition, the vascularization of the conduit can be confirmed using the near-infrared camera of the robot with the ICG dye. The second stage of the operation will involve a 4-port robotic approach through the right chest to achieve thoracic nodal dissection, esophagectomy, and a hand-sewn anastomosis between the residual esophagus and the gastric conduit at the level of the azygous vein. During this second stage of the operation, NIF with ICG dye will be used to visualize the vascular supply of the gastric conduit, and assess the gastric conduit for any perfusions to potentially reduce anastomotic leaks.

Group II: Open Transthoracic Esophagectomy (OTE)Active Control1 Intervention

The patient will undergo OTE using the standard Ivor-Lewis approach. This is a two-stage operation involving a first stage through laparotomy, proximal gastrectomy, D2 nodal dissection, and insertion of feeding jejunostomy. The second stage of the operation will involve a right thoracotomy, thoracic nodal dissection, esophagectomy, and a stapled anastomosis between the residual esophagus and the gastric conduit at the level of the azygous vein.

0 / 4Eligibility criteria met