Esophageal NeoplasmsNCT06070376
Comparative Study Between (FC-SEMS) and (PC-SEMS) in the Palliation of Dysphagia Due to Malignant Neoplasm of Esophagus.
A study testing Fully Covered Esophageal Prosthesis (FC-SEMS) and Partially Covered Esophageal Prosthesis (PC-SEMS) in people with Esophageal Neoplasms and Dysphagia, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial summary
Esophageal cancer is the seventh most common type of cancer in the world, with an estimated global incidence of 604,100 new cases per year. The main symptom of esophageal cancer is dysphagia, associated or not with weight loss. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Neoplasms, Dysphagia
- What is being tested?
- Fully Covered Esophageal Prosthesis (FC-SEMS) and Partially Covered Esophageal Prosthesis (PC-SEMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- 26 Jun 2023to 26 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients with advanced malignant neoplasm of the esophagus, whether or not undergoing chemotherapy or radiotherapy;
- Dysphagia score greater than 2 or presence of malignant esophagorespiratory fistula;
- Indication of palliation of dysphagia through the placement of esophageal prostheses in a multidisciplinary meeting.
Who cannot join
- Patients under 18 years;
- Extraesophageal neoplasms;
- Lesions with longitudinal extension less than 30 mm;
- Previous treatment with esophageal prosthesis;
- Tumors easily transposed to standard endoscope (9.8mm).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Instituto do Câncer do Estado de São Paulo
São Paulo, São Paulo, 01246-000
Fauze Maluf-Filho, PhD, +5511991919014, fauze.maluf@terra.com.br
About this study
Official title: Comparative Study Between Fully Covered Esophageal Prosthesis (FC-SEMS) and Partially Covered Esophageal Prosthesis (PC-SEMS) in the Palliation of Dysphagia Due to Malignant Neoplasm of Esophagus.
Esophageal cancer is the seventh most common type of cancer in the world, with an estimated global incidence of 604,100 new cases per year. The main symptom of esophageal cancer is dysphagia, associated or not with weight loss. Unfortunately, due to asymptomatic presentation in the early stages, more than half of patients are diagnosed in advanced stages of the disease, becoming ineligible for treatment with curative intent. In this sense, chemotherapy and radiotherapy are the pillars of palliative treatment, often regressing the injury and improving symptoms. However, some patients persist with dysphagia. In this scenario, esophageal prostheses are one of the main tools in the palliative treatment of esophageal cancer dysphagia, obtaining rapid and lasting relief of dysphagia. This study aims to compare fully covered (FC-SEMS) and partially covered (PC-SEMS) esophageal prostheses in this context, evaluating the number of reinterventions in each group, as well as the occurrence of adverse events. However, it is expected that with the data obtained it is possible to develop clearer and more effective protocols in the palliation of malignant dysphagia of esophageal stenosis.
Read the detailed description
STUDY DESIGN: Prospective and randomized study will be conducted.
PREPARATION AND TECHNICAL STEPS OF THE PROCEDURE: The placement of the esophageal prosthesis will be performed under sedation or general anesthesia supervised by the anesthesiologist at the endoscopy service of the Cancer Institute of the State of São Paulo (ICESP). The tests will be performed under radioscopic control. The tests will be performed on an outpatient basis, and hospitalization may occur in case of clinical need.
- Conditions
- Esophageal Neoplasms, Dysphagia
- Being tested
- Fully Covered Esophageal Prosthesis (FC-SEMS), Partially Covered Esophageal Prosthesis (PC-SEMS)
- Keywords
- Esophageal Neoplasms, Palliation of dysphagia, Esophageal stent
- Medical subject headings
- Esophageal Neoplasms, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fully Covered Esophageal Prosthesis (FC-SEMS)Device
The placement of the Fully Covered Esophageal Prosthesis (FC-SEMS) will be performed under sedation or general anesthesia supervised by the anesthesiologist at the endoscopy service of the Cancer Institute of the State of São Paulo (ICESP). The tests will be performed under radioscopic control. The tests will be performed on an outpatient basis, and hospitalization may occur in case of clinical need.
Partially Covered Esophageal Prosthesis (PC-SEMS)Device
The placement of the Partially Covered Esophageal Prosthesis (PC-SEMS) will be performed under sedation or general anesthesia supervised by the anesthesiologist at the endoscopy service of the Cancer Institute of the State of São Paulo (ICESP). The tests will be performed under radioscopic control. The tests will be performed on an outpatient basis, and hospitalization may occur in case of clinical need.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | placement of the esophageal prostheses fully covered in the palliative treatment of malignant esophageal obstructions. Receives: Device: Fully Covered Esophageal Prosthesis (FC-SEMS) |
| Group B | Active comparator | placement of the partially covered esophageal prostheses in the palliative treatment of malignant esophageal obstructions. Receives: Device: Partially Covered Esophageal Prosthesis (PC-SEMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reinterventions
Number of reinterventions after the procedure.
Measured: 2 years
Secondary outcomes (2)
Adverse events and patency time of the prostheses
Number of adverse events
Measured: 2 years
Patency time of the prostheses.
Days without need a new prothesis or procedure
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start26 Jun 2023
- Primary completion26 Feb 2027 (estimated)
- Study completion26 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal NeoplasmsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fauze Maluf Filho, Instituto do Cancer do Estado de São Paulo
- Investigators
- Fauze Maluf-Filho, PhD, Principal investigator, Cancer Institute of the state of São Paulo (ICESP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06070376
- Sponsor's protocol ID
- NP3080/22
- Status last verified
- Jul 2026
- First submitted
- 27 Sep 2023
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Fully Covered Esophageal Prosthesis (FC-SEMS) and Partially Covered Esophageal Prosthesis (PC-SEMS) in the Palliation of Dysphagia Due to Malignant Neoplasm of Esophagus.
- ClinicalTrials.gov ID
- NCT06070376
- Acronym / sponsor ID
- NP3080/22
- Conditions
- Esophageal Neoplasms, Dysphagia
- Keywords
- Esophageal Neoplasms, Palliation of dysphagia, Esophageal stent
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- 26 Feb 2027 (estimated)
- Study completion
- 26 Aug 2027 (estimated)
- First posted
- 6 Oct 2023 (actual)
- 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 the seventh most common type of cancer in the world, with an estimated global incidence of 604,100 new cases per year. The main symptom of esophageal cancer is dysphagia, associated or not with weight loss. Unfortunately, due to asymptomatic presentation in the early stages, more than half of patients are diagnosed in advanced stages of the disease, becoming ineligible for treatment with curative intent. In this sense, chemotherapy and radiotherapy are the pillars of palliative treatment, often regressing the injury and improving symptoms. However, some patients persist with dysphagia. In this scenario, esophageal prostheses are one of the main tools in the palliative treatment of esophageal cancer dysphagia, obtaining rapid and lasting relief of dysphagia. This study aims to compare fully covered (FC-SEMS) and partially covered (PC-SEMS) esophageal prostheses in this context, evaluating the number of reinterventions in each group, as well as the occurrence of adverse events. However, it is expected that with the data obtained it is possible to develop clearer and more effective protocols in the palliation of malignant dysphagia of esophageal stenosis.
Detailed description
STUDY DESIGN: Prospective and randomized study will be conducted.
PREPARATION AND TECHNICAL STEPS OF THE PROCEDURE: The placement of the esophageal prosthesis will be performed under sedation or general anesthesia supervised by the anesthesiologist at the endoscopy service of the Cancer Institute of the State of São Paulo (ICESP). The tests will be performed under radioscopic control. The tests will be performed on an outpatient basis, and hospitalization may occur in case of clinical need.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Device: Fully Covered Esophageal Prosthesis (FC-SEMS)placement of the esophageal prostheses fully covered in the palliative treatment of malignant esophageal obstructions. |
| Group B | Active comparator | Device: Partially Covered Esophageal Prosthesis (PC-SEMS)placement of the partially covered esophageal prostheses in the palliative treatment of malignant esophageal obstructions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with advanced malignant neoplasm of the esophagus, whether or not undergoing chemotherapy or radiotherapy;
- Dysphagia score greater than 2 or presence of malignant esophagorespiratory fistula;
- Indication of palliation of dysphagia through the placement of esophageal prostheses in a multidisciplinary meeting.
Key exclusion criteria (5 listed)
- Patients under 18 years;
- Extraesophageal neoplasms;
- Lesions with longitudinal extension less than 30 mm;
- Previous treatment with esophageal prosthesis;
- Tumors easily transposed to standard endoscope (9.8mm).
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 |
|---|---|---|
| Fully Covered Esophageal Prosthesis (FC-SEMS)The placement of the Fully Covered Esophageal Prosthesis (FC-SEMS) will be performed under sedation or general anesthesia supervised by the anesthesiologist at the endoscopy service of the Cancer Institute of the State of São Paulo (ICESP). The tests will be performed under radioscopic control. The tests will be performed on an outpatient basis, and hospitalization may occur in case of clinical need. | Device | Group A |
| Partially Covered Esophageal Prosthesis (PC-SEMS)The placement of the Partially Covered Esophageal Prosthesis (PC-SEMS) will be performed under sedation or general anesthesia supervised by the anesthesiologist at the endoscopy service of the Cancer Institute of the State of São Paulo (ICESP). The tests will be performed under radioscopic control. The tests will be performed on an outpatient basis, and hospitalization may occur in case of clinical need. | Device | Group B |
Primary outcome
Reinterventions
Time frame: 2 years
Number of reinterventions after the procedure.
2 secondary outcomes
Adverse events and patency time of the prostheses
Time frame: 2 years
Patency time of the prostheses.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
Related trials for Esophageal Neoplasms
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
RecruitingPhase 1
Study of XB010 in Subjects With Solid Tumors
Locally Advanced or Metastatic Solid Tumors, Esophageal Squamous Cell Cancer
RecruitingPhase 2/3
Adding Nivolumab to Usual Treatment for People With Advanced Stomach or Esophageal Cancer, PARAMUNE Trial
Advanced Esophageal Adenocarcinoma, Advanced Gastric Adenocarcinoma
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
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.
Fauze Maluf-Filho, PhD principal investigator
Cancer Institute of the state of São Paulo (ICESP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fully Covered Esophageal Prosthesis (FC-SEMS) and Partially Covered Esophageal Prosthesis (PC-SEMS) in people with Esophageal Neoplasms and Dysphagia, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 17 Jul 2026. 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 Brazil. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fauze Maluf-Filho, PhD (+5511991919014, fauze.maluf@terra.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reinterventions (time frame: 2 years). 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 17 Jul 2026.