Endoscopic Prevention of Esophageal Cancer at Tenwek Hospital

Esophageal Cancer Clinical Trial

— EXPECT  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02146508
• Other study ID #: P62/02/2013
• Status: Suspended
• Phase: N/A
• Start date: June 2013
• Est. completion date: July 2024

Study information

• Verified date: December 2023
• Source: Tenwek Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 75
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Esophageal Squamous Dysplasia

Intervention

Procedure:
• Endoscopic Mucosal Resection (EMR)
Endoscopic removal of regions of ESD.

Device:
• Radiofrequency ablation
Endoscopic radiofrequency ablation of regions of ESD

Locations

Country	Name	City	State
Kenya	Tenwek Hospital	Bomet

Sponsors (4)

Lead Sponsor	Collaborator
Tenwek Hospital	Mayo Clinic, Medtronic - MITG, National Cancer Institute (NCI)

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety of endoscopic interventions	Percentage of participants experiencing serious adverse events following EMR or RFA treatment.	12 months