Endoscopic Prevention of Esophageal Cancer at Tenwek Hospital

NCT02146508 | Suspended DMC

• 1 other identifier: P62/02/2013
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Esophageal Cancer; Esophageal Squamous Dysplasia

Keywords

Esophageal cancer; Radiofrequency, catheter ablation; Endoscopic mucosal resection; Esophageal squamous dysplasia; Cancer prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety of endoscopic interventions

  12 months

Study Arms (1)

Endoscopic treatment

EXPERIMENTAL

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); Device: Radiofrequency ablation

Interventions

Endoscopic Mucosal Resection (EMR) PROCEDURE

Endoscopic removal of regions of ESD.

Endoscopic treatment

Radiofrequency ablation DEVICE

Endoscopic radiofrequency ablation of regions of ESD

Also known as: HALO360 (Covidien, Inc.), HALO90 (Covidien, Inc.), HALO60 (Covidien, Inc.)

Endoscopic treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tenwek Hospital: lead
• Mayo Clinic: collaborator
• National Cancer Institute (NCI): collaborator
• Medtronic - MITG: collaborator

Study Sites (1)

Tenwek Hospital

Bomet, 02400, Kenya

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Endoscopic Mucosal Resection; Radiofrequency Ablation

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)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Radiofrequency Therapy; Therapeutics; Ablation Techniques

Study Officials

• Stephen L Burgert, MD

  Tenwek Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Endoscopy Services

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: May 23, 2014
• Study Start: June 1, 2013
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: December 11, 2023

Record last verified: 2023-12

Locations

KE (1)