Esophageal CancerEXPECTNCT02146508
Endoscopic Prevention of Esophageal Cancer at Tenwek Hospital
A study testing Endoscopic Mucosal Resection (EMR) and Radiofrequency ablation in people with Esophageal Cancer and Esophageal Squamous Dysplasia, run by Tenwek Hospital at 1 site in Kenya.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Esophageal Cancer, Esophageal Squamous Dysplasia
- What is being tested?
- Endoscopic Mucosal Resection (EMR) and Radiofrequency ablation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteKenya
- Study dates
- Jun 2013to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Esophageal Cancer, Esophageal Squamous Dysplasia
- Being tested
- Endoscopic Mucosal Resection (EMR), Radiofrequency ablation
- Keywords
- Esophageal cancer, Radiofrequency, catheter ablation, Endoscopic mucosal resection, Esophageal squamous dysplasia, Cancer prevention
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Mucosal Resection (EMR)Procedure or surgery
Endoscopic removal of regions of ESD.
Radiofrequency ablationDevice
Also called HALO360 (Covidien, Inc.), HALO90 (Covidien, Inc.), HALO60 (Covidien, Inc.)
Endoscopic radiofrequency ablation of regions of ESD
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Endoscopic Mucosal Resection (EMR); Device: Radiofrequency ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
Safety of endoscopic interventions
Percentage of participants experiencing serious adverse events following EMR or RFA treatment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study startJun 2013
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Why it stopped: Medtronic owns Covidien \& closed study 11/18/15. Will reapply through Medtronic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tenwek Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic, National Cancer Institute (NCI), Medtronic - MITG
- Responsible party
- Principal investigator, Stephen Burgert, Tenwek Hospital
- Investigators
- Stephen L Burgert, MD, Principal investigator, Tenwek Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02146508
- Sponsor's protocol ID
- P62/02/2013
- Acronym
- EXPECT
- Status last verified
- Dec 2023
- First submitted
- 21 May 2014
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Prevention of Esophageal Cancer at Tenwek Hospital (The EXPECT Trial) by Removal or Ablation of Esophageal Squamous Cell Dysplasia
- ClinicalTrials.gov ID
- NCT02146508
- Acronym / sponsor ID
- EXPECT / P62/02/2013
- Conditions
- Esophageal Cancer, Esophageal Squamous Dysplasia
- Keywords
- Esophageal cancer, Radiofrequency, catheter ablation, Endoscopic mucosal resection, Esophageal squamous dysplasia, Cancer prevention
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Medtronic owns Covidien \& closed study 11/18/15. Will reapply through Medtronic.
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Tenwek HospitalUniversity, hospital or other
- Collaborators
- Mayo Clinic, National Cancer Institute (NCI), Medtronic - MITG
- Study start
- Jun 2013
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 23 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic treatment | Experimental | Procedure: Endoscopic Mucosal Resection (EMR), Device: Radiofrequency ablationParticipants 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic Mucosal Resection (EMR)Endoscopic removal of regions of ESD. | Procedure or surgery | Endoscopic treatment |
| Radiofrequency ablationAlso: HALO360 (Covidien, Inc.), HALO90 (Covidien, Inc.), HALO60 (Covidien, Inc.)Endoscopic radiofrequency ablation of regions of ESD | Device | Endoscopic treatment |
Primary outcome
Complete resolution of advanced esophageal squamous dysplasia
Time frame: 12 months
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.
1 secondary outcome
Safety of endoscopic interventions
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen L Burgert, MD principal investigator
Tenwek Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Mucosal Resection (EMR) and Radiofrequency ablation in people with Esophageal Cancer and Esophageal Squamous Dysplasia, run by Tenwek Hospital at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete resolution of advanced esophageal squamous dysplasia (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.