Esophageal CancerPhase 1NCT01894763
Prospective Comparison of Large vs. Small Diameter Esophageal Stents for Palliation of Malignant Dysphagia
A Phase 1 study testing Self-expandable metal stent in people with Esophageal Cancer, run by Mayo Clinic at 1 site in Kenya.
Trial summary
Esophageal cancer often causes difficulty swallowing (dysphagia) that can be relieved by placement of a stent (a flexible, expandable tube that props open the blockage caused by the cancer). Stents are effective but can cause complications. Stents come in different diameters. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Self-expandable metal stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteKenya
- Study dates
- Sep 2003to May 2009
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 years
- dysphagia due to unresectable esophageal cancer
- participant resides within 50 km of Tenwek Hospital
- tumor is ≤ 9 cm in length and > 2 cm distal to the upper esophageal sphincter (UES)
- no esophago-respiratory fistula (ERF) or suspected perforation is present
Who cannot join
- unable to provide written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Prospective Comparison of Large vs. Small Diameter Esophageal Stents for Palliation of Malignant Dysphagia
Esophageal cancer often causes difficulty swallowing (dysphagia) that can be relieved by placement of a stent (a flexible, expandable tube that props open the blockage caused by the cancer). Stents are effective but can cause complications. Stents come in different diameters. The purpose of this study is to learn if stents of different diameters are more or less effective for treatment of dysphagia caused by esophageal cancer.
Read the detailed description
This prospective, randomized study was conducted at Tenwek Hospital in Bomet, Kenya, and was approved by the hospital's institutional review board (IRB) as well as the Kenya Medical Research Institute's Ethical Review Committee. Participants with dysphagia were recruited and provided signed informed consent prior to endoscopy. During endoscopy and after dilation of an obstructing esophageal tumor sufficient to permit passage of an endoscope, eligible participants were enrolled and randomized to receive either an 18 mm shaft/23 mm flange or 23 mm shaft/28 mm flange partially covered Ultraflex esophageal stent (Boston Scientific, Natick, Massachusets, USA). Stents were either 10 or 12 cm in length, and the endoscopist chose a stent length based on the length of the malignant stricture. One stent was placed in each subject. Follow-up was then obtained at scheduled intervals after stent placement (7 and 28 days, 3 months, then every 3 months), until the participant's death. Earlier follow-up visits were arranged if participants reported any new health concerns.
Block randomization was performed using the sealed envelope technique, with 10 participants in each block; none of the study personnel at Tenwek Hospital had knowledge of the randomization sequence. Allocation was concealed from participants, caregivers, and study personnel until randomization occurred during an endoscopic procedure. After randomization, stent diameters were known to the endoscopy staff and listed in the medical record. All randomized participants correctly received a stent of the allocated diameter, and remained blinded to the stent diameter they received.
At baseline and each follow-up visit body weight was recorded, as well as Karnofsky performance status score, dysphagia score (0=normal, no dysphagia; 1=can swallow most foods; 2=can swallow a soft diet; 3=can swallow fluids only; 4=unable to swallow saliva), current medications, and the presence or absence of 15 symptoms and 9 diagnoses (weakness, fever, vomiting, vomiting blood, melena, weak voice, difficulty breathing, cough, sputum, palpitations, heartburn, chest pain, hiccoughs, recurrent dysphagia, abdominal pain; anemia, gastrointestinal bleeding, esophago-respiratory fistula, arrhythmia, pneumonia, metastases, stent occlusion, stent migration, gastroesophageal reflux disease). In addition, all interval clinic visits, test results, endoscopy reports, and hospitalizations were reviewed.
- Conditions
- Esophageal Cancer
- Being tested
- Self-expandable metal stent
- Keywords
- esophagus, cancer
- Medical subject headings
- Esophageal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-expandable metal stentDevice
Also called Ultraflex Esophageal Stents
Placement of a self-expandable metal stent in the esophagus
| Study group | Role | What they receive |
|---|---|---|
| Small-diameter stent | Active comparator | Placement of a 23 mm self-expandable metal stent Receives: Device: Self-expandable metal stent |
| Large-diameter stent | Active comparator | Placement of a 28-mm self-expandable metal stent Receives: Device: Self-expandable metal stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief of dysphagia
Number of participants with improvement in dysphagia score to <2
Measured: 1 month following stent placement
Complications
Number of participants who experience stent-related symptoms (including chest pain, recurrent dysphagia, hematemesis, melena, palpitations) or complications (including gastrointestinal hemorrhage, esophago-respiratory fistula, stent migration, stent occlusion) from the time of stent placement until death or 5-year follow-up.
Measured: from stent placement to death or 5 years of follow-up, whichever comes first
Mortality
Time (in days) from stent placement to death, assessed by Kaplan-Meier analysis
Measured: from stent placement to death or 5 years of follow-up, whichever comes first
Secondary outcomes (2)
Endoscopic re-intervention
Number of participants undergoing repeat endoscopy to diagnose or treat a stent-related problem at any time from stent placement to death or 5 year follow-up.
Measured: from stent placement to death or 5 years of follow-up, whichever comes first
performance status
Karnofsky performance status, assessed by Kaplan Meier analysis, from stent placement to death or 5-year follow-up.
Measured: from stent placement to death or 5 years of follow-up, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study startSep 2003
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Tenwek Hospital, Bomet, Kenya
- Responsible party
- Principal investigator, Mark Topazian, Mayo Clinic
- Investigators
- Russell White, M.D., Principal investigator, Tenwek Hospital, Bomet, Kenya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01894763
- Sponsor's protocol ID
- 1063-04
- Status last verified
- Jul 2013
- First submitted
- 26 Jun 2013
- Last updated
- 10 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
White RE, Chepkwony R, Mwachiro M, Burgert SL, Enders FT, Topazian M. Randomized Trial of Small-diameter Versus Large-diameter Esophageal Stents for Palliation of Malignant Esophageal Obstruction. J Clin Gastroenterol. 2015 Sep;49(8):660-5. doi: 10.1097/MCG.0000000000000333.
PubMed 25992812
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Prospective Comparison of Large vs. Small Diameter Esophageal Stents for Palliation of Malignant Dysphagia
- ClinicalTrials.gov ID
- NCT01894763
- Acronym / sponsor ID
- 1063-04
- Conditions
- Esophageal Cancer
- Keywords
- esophagus, cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Tenwek Hospital, Bomet, Kenya
- Study start
- Sep 2003
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 10 Jul 2013 (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 often causes difficulty swallowing (dysphagia) that can be relieved by placement of a stent (a flexible, expandable tube that props open the blockage caused by the cancer). Stents are effective but can cause complications. Stents come in different diameters. The purpose of this study is to learn if stents of different diameters are more or less effective for treatment of dysphagia caused by esophageal cancer.
Detailed description
This prospective, randomized study was conducted at Tenwek Hospital in Bomet, Kenya, and was approved by the hospital's institutional review board (IRB) as well as the Kenya Medical Research Institute's Ethical Review Committee. Participants with dysphagia were recruited and provided signed informed consent prior to endoscopy. During endoscopy and after dilation of an obstructing esophageal tumor sufficient to permit passage of an endoscope, eligible participants were enrolled and randomized to receive either an 18 mm shaft/23 mm flange or 23 mm shaft/28 mm flange partially covered Ultraflex esophageal stent (Boston Scientific, Natick, Massachusets, USA). Stents were either 10 or 12 cm in length, and the endoscopist chose a stent length based on the length of the malignant stricture. One stent was placed in each subject. Follow-up was then obtained at scheduled intervals after stent placement (7 and 28 days, 3 months, then every 3 months), until the participant's death. Earlier follow-up visits were arranged if participants reported any new health concerns.
Block randomization was performed using the sealed envelope technique, with 10 participants in each block; none of the study personnel at Tenwek Hospital had knowledge of the randomization sequence. Allocation was concealed from participants, caregivers, and study personnel until randomization occurred during an endoscopic procedure. After randomization, stent diameters were known to the endoscopy staff and listed in the medical record. All randomized participants correctly received a stent of the allocated diameter, and remained blinded to the stent diameter they received.
At baseline and each follow-up visit body weight was recorded, as well as Karnofsky performance status score, dysphagia score (0=normal, no dysphagia; 1=can swallow most foods; 2=can swallow a soft diet; 3=can swallow fluids only; 4=unable to swallow saliva), current medications, and the presence or absence of 15 symptoms and 9 diagnoses (weakness, fever, vomiting, vomiting blood, melena, weak voice, difficulty breathing, cough, sputum, palpitations, heartburn, chest pain, hiccoughs, recurrent dysphagia, abdominal pain; anemia, gastrointestinal bleeding, esophago-respiratory fistula, arrhythmia, pneumonia, metastases, stent occlusion, stent migration, gastroesophageal reflux disease). In addition, all interval clinic visits, test results, endoscopy reports, and hospitalizations were reviewed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Small-diameter stent | Active comparator | Device: Self-expandable metal stentPlacement of a 23 mm self-expandable metal stent |
| Large-diameter stent | Active comparator | Device: Self-expandable metal stentPlacement of a 28-mm self-expandable metal stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age ≥ 18 years
- dysphagia due to unresectable esophageal cancer
- participant resides within 50 km of Tenwek Hospital
- tumor is ≤ 9 cm in length and > 2 cm distal to the upper esophageal sphincter (UES)
- no esophago-respiratory fistula (ERF) or suspected perforation is present
Key exclusion criteria (1 listed)
- unable to provide written informed consent
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 |
|---|---|---|
| Self-expandable metal stentAlso: Ultraflex Esophageal StentsPlacement of a self-expandable metal stent in the esophagus | Device | Large-diameter stent, Small-diameter stent |
Primary outcome
Relief of dysphagia
Time frame: 1 month following stent placement
Number of participants with improvement in dysphagia score to <2
Complications
Time frame: from stent placement to death or 5 years of follow-up, whichever comes first
Number of participants who experience stent-related symptoms (including chest pain, recurrent dysphagia, hematemesis, melena, palpitations) or complications (including gastrointestinal hemorrhage, esophago-respiratory fistula, stent migration, stent occlusion) from the time of stent placement until death or 5-year follow-up.
Mortality
Time frame: from stent placement to death or 5 years of follow-up, whichever comes first
Time (in days) from stent placement to death, assessed by Kaplan-Meier analysis
2 secondary outcomes
Endoscopic re-intervention
Time frame: from stent placement to death or 5 years of follow-up, whichever comes first
performance status
Time frame: from stent placement to death or 5 years of follow-up, whichever comes first
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2013.
- Derived from this study: PubMed 25992812White RE, Chepkwony R, Mwachiro M, Burgert SL, Enders FT, Topazian M. Randomized Trial of Small-diameter Versus Large-diameter Esophageal Stents for Palliation of Malignant Esophageal Obstruction. J Clin Gastroenterol. 2015 Sep;49(8):660-5. doi: 10.1097/MCG.0000000000000333.
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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.
Russell White, M.D. principal investigator
Tenwek Hospital, Bomet, Kenya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Self-expandable metal stent in people with Esophageal Cancer, run by Mayo Clinic 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 5 inclusion and 1 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: finished, as of the sponsor's last update on 10 Jul 2013. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Relief of dysphagia (time frame: 1 month following stent placement). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01894763, which also lists 1 linked publication.
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 10 Jul 2013; AzTrials last refreshed its copy on 7 Nov 2026.