Endoscopic Prevention of Esophageal Cancer at Tenwek Hospital

• Register: ClinicalTrials.gov
• Last refreshed on: 19 December 2023
• Main ID: NCT02146508
• Date of registration: 21/05/2014
• Prospective Registration: No
• Primary sponsor: Tenwek Hospital
• Public title: Endoscopic Prevention of Esophageal Cancer at Tenwek Hospital EXPECT
• Scientific title: Endoscopic Prevention of Esophageal Cancer at Tenwek Hospital (The EXPECT Trial) by Removal or Ablation of Esophageal Squamous Cell Dysplasia
• Date of first enrolment: June 2013
• Target sample size: 75
• Recruitment status: Suspended
• URL: https://clinicaltrials.gov/ct2/show/NCT02146508
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Kenya

Contacts

• Name: Stephen L Burgert, MD
• Affiliation: Tenwek Hospital

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Esophageal Cancer

Esophageal Squamous Dysplasia

Intervention(s)

Device: Radiofrequency ablation

Procedure: Endoscopic Mucosal Resection (EMR)

Primary Outcome(s)

Complete resolution of advanced esophageal squamous dysplasia [Time Frame: 12 months]

Secondary Outcome(s)

Safety of endoscopic interventions [Time Frame: 12 months]

Secondary ID(s)

P62/02/2013

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)

Medtronic - MITG

Mayo Clinic