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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during surgery
Awards & highlights
RAMIE vs OTE Trial 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.Check my eligibility
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.See study design
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.
RAMIE vs OTE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My esophageal cancer is in an early stage and I am a candidate for surgery.
RAMIE vs OTE Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The feasibility of a large-scale RCT, as measured by the number of patients willing to participate in the study.
Secondary outcome measures
Conversion from RAMIE to OTE
Length of Operation
Length of Stay (LOS)
+4 moreRAMIE vs OTE 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.
Find a Location
Who is running the clinical trial?
St. Joseph's Healthcare HamiltonLead Sponsor
196 Previous Clinical Trials
25,490 Total Patients Enrolled
McMaster UniversityOTHER
881 Previous Clinical Trials
2,597,832 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant, breastfeeding, and if able to bear children, I am using effective birth control.I am 18 years old or older.My esophageal cancer is in stage IV.My surgeon has approved me for a less invasive surgery.My surgeon has decided I can't have minimally invasive surgery.My esophageal cancer is in an early stage and I am a candidate for surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Open Transthoracic Esophagectomy (OTE)
- Group 2: NIF-Guided RAMIE using ICG Dye (Experimental Arm)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the aggregate amount of participants involved in this experiment?
"Affirmative. As per the data found on clinicaltrials.gov, this scientific experiment is still recruiting individuals to partake in it; first posted on May 1st and last edited on July 25th 2022, with a total of 54 participants needed at one site."
Answered by AI
Is registration available for this clinical experiment?
"According to data available on clinicaltrials.gov, this investigation is presently seeking suitable candidates; the trial was first made public on May 1st 2022 and its most recent update occurred July 25th 2022."
Answered by AI
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