Endoscopic Prevention of Esophageal Cancer at Tenwek Hospital (EXPECT)

Endoscopic Prevention of Esophageal Cancer at Tenwek Hospital (The EXPECT Trial) by Removal or Ablation of Esophageal Squamous Cell Dysplasia

Esophageal cancer is common in Kenya. The precursor of esophageal cancer is esophageal squamous dysplasia (ESD). In this study, persons known to have ESD will undergo endoscopic removal or ablation of ESD in order to prevent development of esophageal cancer.

Study Overview

• Status: Suspended
• Conditions: Esophageal Cancer; Esophageal Squamous Dysplasia
• Intervention / Treatment: Procedure: Endoscopic Mucosal Resection (EMR); Device: Radiofrequency ablation

Detailed Description

Esophageal squamous dysplasia (ESD) is the precursor lesion of esophageal squamous cell cancer. ESD causes no symptoms but can be detected by screening. ESD may harbor various grades of dysplasia. Patients with moderate grade or high grade dysplasia (MGD or HGD) have up to a 40-fold increased risk of esophageal squamous cell cancer.

In this study, persons known to have ESD with MGD or HGD on the basis of prior screening will be invited to undergo endoscopic treatment with either endoscopic mucosal resection (EMR) and/or radio frequency ablation (RFA) in order to remove or ablate regions of ESD. Participants will undergo a series of endoscopies to treat ESD and monitor success of treatment.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Bomet, Kenya, 02400
    • Tenwek Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant is 18-85 years of age, inclusive
• Participant has had a prior endoscopy with Lugol's chromoendoscopy demonstrating an unstained lesion (USL) of at least 5 mm which on biopsy contained moderate grade dysplasia (MGD), high grade dysplasia (HGD), or esophageal squamous cell cancer (ESCC) of flat mucosa limited to the lamina propria, with no evidence of invasion.
• The maximum allowable linear length of USL-bearing esophagus is 20 cm.
• No more than 14 continuous linear cm of esophagus require treatment for MGD, HGD, or ESCC.
• For patients with ESCC, CT scan of chest and upper third of the abdomen shows no exclusionary findings for the trial, such as metastasis.
• Participant is not pregnant and has no plans to become pregnant in the ensuing 12 months (confirmation of pregnancy status in women of child-bearing age and ability required prior to each endoscopy with urine or blood test, if subject believes she may be pregnant or has missed a menstrual period)
• Participant is eligible for treatment and follow-up endoscopy and biopsy as required by the protocol
• Participant is willing to provide written, informed consent to participate in this clinical study and understands the responsibilities of trial participation

Exclusion Criteria:

• Esophageal stricture preventing passage of a therapeutic endoscope
• Any prior endoscopic resection
• Any esophageal dilation in the past 12 months
• Any history of ESCC of the esophagus, except for ESCC of flat mucosa limited to the lamina propria diagnosed within 12 months of study enrollment.
• In participants with ESCC, any evidence of nodal involvement or distant metastases
• Any previous ablative therapy within the esophagus (photodynamic therapy, multipolar electrical coagulation, argon plasma coagulation, laser treatment, or other) or any radiation therapy to the esophagus.
• Any previous esophageal surgery, except fundoplication
• Evidence of esophageal varices detected within last 6 months or at initial EMR/RFA procedure
• Evidence of eosinophilic esophagitis on endoscopy and/or histology
• History of coagulopathy, or use of warfarin within the past month.
• Report of uncontrolled coagulopathy with international normalized ratio (INR) > 2 or platelet count <75,000 platelets per µL (note: laboratory testing is not required for all subjects in this study)
• Participant is using aspirin, clopidogrel, or non-steroidal anti-inflammatory drugs that cannot be discontinued 7 days before and after therapeutic sessions
• Participant has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines
• Participant has an implantable pacing device (examples; automatic implantable cardioverter/defibrillator, neurostimulator, cardiac pacemaker) and has not received clearance for enrollment in this study by the physician responsible for the pacing device
• Participant suffers from psychiatric or other illness deemed by the investigator as an inability to comply with protocol
• Participant has life expectancy less than 2 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endoscopic treatment; Participants undergo upper GI endoscopy with endoscopic mucosal resection (EMR) and/or radiofrequency ablation (RFA) of esophageal squamous dysplasia (ESD). After initial therapy participants undergo repeat endoscopy every 3 months for a year, with re-biopsy and re-treatment of residual ESD as appropriate.	Procedure: Endoscopic Mucosal Resection (EMR); Endoscopic removal of regions of ESD.; Device: Radiofrequency ablation; Endoscopic radiofrequency ablation of regions of ESD; Other Names: HALO360 (Covidien, Inc.); HALO90 (Covidien, Inc.); HALO60 (Covidien, Inc.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete resolution of advanced esophageal squamous dysplasia	The percentage of subjects demonstrating complete response defined as complete histological clearance of MGD, HGD and esophageal squamous carcinoma in the treatment areas at 12 months after the initial ablation procedure.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of endoscopic interventions	Percentage of participants experiencing serious adverse events following EMR or RFA treatment.	12 months

Collaborators and Investigators

• Sponsor: Tenwek Hospital
• Collaborators: National Cancer Institute (NCI); Mayo Clinic; Medtronic - MITG
• Investigators: Principal Investigator: Stephen L Burgert, MD, Tenwek Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: May 21, 2014
• First Submitted That Met QC Criteria: May 21, 2014
• First Posted (Estimated): May 23, 2014

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Esophageal cancer; Endoscopic mucosal resection; Radiofrequency, catheter ablation; Esophageal squamous dysplasia; Cancer prevention
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: P62/02/2013