Esophageal StrictureESOGRAFTNCT04221867
Feasibility and Therapeutic Potential of Free Fat Grafts in the Treatment of Esophageal Strictures (ESOGRAFT)
A study testing Stricture dilation with CRE balloon and Autologous fat grafting in people with Esophageal Stricture and Fat Graft, run by Hannes Kortekangas.
Trial summary
In this study the investigators investigate the feasibility and therapeutic potential of free autologous fat grafting combined to dilation therapy in the treatment of benign esophageal strictures. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Esophageal Stricture, Fat Graft
- What is being tested?
- Stricture dilation with CRE balloon and Autologous fat grafting
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2021to 1 Mar 2023
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Esophageal stricture that has re-occurred at least once
Who cannot join
- Malignant etiology of esophageal stricture
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Feasibility and Therapeutic Potential of Free Fat Grafts in the Treatment of Esophageal Strictures
In this study the investigators investigate the feasibility and therapeutic potential of free autologous fat grafting combined to dilation therapy in the treatment of benign esophageal strictures.
Read the detailed description
In this study the investigators wish to proof the concept of free fat graft transfer into esophageal stricture via flexible video gastroscope.The investigators will recruit twenty patients suffering from (endoscopy proven) benign stricture of the esophagus. The Eckardt score is recorded upon recruitment and one day before operation.
The operation is performed at the gastroenterology outpatient clinic in Turku University Hospital by a gastrointestinal surgeon. The patient is sedated with alfentanil and midazolam. First, abdominal liposuction (roughly 20 ml) is performed under local infiltration anesthesia. The fat graft is processed into nano-fat using Tulip GEMS Single-Use NanoTransfer Set. Esophagoscopy with gastroscope is performed and stricture is visually graded (location, length, lumen) and photographed. Then esophageal stricture is biopsied with biopsy forceps and dilated with through-the-scope CRE(controlled radial expansion) balloon dilator. Prepared fat graft is injected beneath the mucosal layer at the stricture site (volume of 0,1-0,5 ml) at three locations. Patients are either discharged after two hours follow up or admitted to the inpatient ward, depending on the pre- and postoperative condition.
Patients are contacted by phone 1 week after the operation. Post-operative symptoms are recorded and patients are requested to contact the researcher if needed. Patient records are screened for pre- and postoperative symptoms, medication, long term illnesses and possible postoperative contacts to hospital.
Follow-up esophagoscopy is performed and biopsies taken three and 12 months after the first operation. The stricture site is visually graded and photographed. The Eckardt score is recorded. If the patient has problems with eating (Eckardt score dysphagia points more than 1) the stricture is re-dilated and fat grafting repeated.
If a patient would have recurrence in dysphagia before three months the patient is treated according to normal routine and dilation is repeated earlier.
The follow-up time is 12 months counting from the last fat grafting.
- Conditions
- Esophageal Stricture, Fat Graft
- Being tested
- Stricture dilation with CRE balloon, Autologous fat grafting
- Keywords
- Esophageal Stricture, Fat Graft, Dilation
- Medical subject headings
- Esophageal Stenosis, Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stricture dilation with CRE balloonProcedure or surgery
Esophageal stricture is treated by dilation therapy.
Autologous fat graftingProcedure or surgery
Autologous fat graft is gathered and injected to stricture
| Study group | Role | What they receive |
|---|---|---|
| Esophageal stricture patients | Experimental | Patients suffering from benign esophageal stricture are treated with through-the scope CRE dilation balloon. Free fat graft is gathered from the abdominal subcutaneous fat. Fat graft is prepared and injected to the stricture site. Receives: Procedure: Stricture dilation with CRE balloon; Procedure: Autologous fat grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events at 3 months
Types, severity and probability of procedure related adverse events
Measured: 3 months
Incidence of Treatment-Emergent Adverse Events at 12 months
Types, severity and probability of procedure related adverse events
Measured: 12 months
Secondary outcomes (6)
Change from Baseline Eckardt score at 3 months
Eckardt score is a validated symptom questionnaire used to measure achalasia symptoms. Esophageal stricture symptoms are similar to achalasia symptoms. Sub scales: Dysphagia, retrosternal pain, regurgitation, weight loss. Each sub scale 0-3 points. 0=none, 1=occasional / less than 5 kg, 2=daily / 5-10kg, 3= each meal /more than 10 kg. Total 0-12 points.
Measured: 3 months
Change from Baseline Eckardt-score at 12 months
Eckardt score is a validated symptom questionnaire used to measure achalasia symptoms. Esophageal stricture symptoms are similar to achalasia symptoms. Sub scales: Dysphagia, retrosternal pain, regurgitation, weight loss. Each sub scale 0-3 points. 0=none, 1=occasional / less than 5 kg, 2=daily / 5-10kg, 3= each meal /more than 10 kg. Total 0-12 points.
Measured: 12 months
Change from Baseline Stricture Lumen diameter at 3 months
Stricture photographed and lumen diameter measurement. Unit: closed biopsy forceps diameter.
Measured: 3 months
Change from Baseline Stricture Lumen diameter at 12 months
Stricture photographed and lumen diameter measurement. Unit: closed biopsy forceps diameter.
Measured: 12 months
Change from Baseline Stricture length at 3 months
Stricture length measured using shaft of biopsy forceps. Unit: mm.
Measured: 3 months
Change from Baseline Stricture length at 12 months
Stricture length measured using shaft of biopsy forceps. Unit: mm.
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 posted9 Jan 2020
- Study start15 Aug 2021 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal StrictureStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannes Kortekangas
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Hannes Kortekangas, Turku University Hospital
- Investigators
- Pauliina Hartiala, Surgeon, Study director, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221867
- Sponsor's protocol ID
- ESOGRAFT
- Acronym
- ESOGRAFT
- Status last verified
- Feb 2021
- First submitted
- 6 Jan 2020
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Therapeutic Potential of Free Fat Grafts in the Treatment of Esophageal Strictures
- ClinicalTrials.gov ID
- NCT04221867
- Acronym / sponsor ID
- ESOGRAFT / ESOGRAFT
- Conditions
- Esophageal Stricture, Fat Graft
- Keywords
- Esophageal Stricture, Fat Graft, Dilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hannes KortekangasOther government
- Study start
- 15 Aug 2021 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 9 Jan 2020 (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.
In this study the investigators investigate the feasibility and therapeutic potential of free autologous fat grafting combined to dilation therapy in the treatment of benign esophageal strictures.
Detailed description
In this study the investigators wish to proof the concept of free fat graft transfer into esophageal stricture via flexible video gastroscope.The investigators will recruit twenty patients suffering from (endoscopy proven) benign stricture of the esophagus. The Eckardt score is recorded upon recruitment and one day before operation.
The operation is performed at the gastroenterology outpatient clinic in Turku University Hospital by a gastrointestinal surgeon. The patient is sedated with alfentanil and midazolam. First, abdominal liposuction (roughly 20 ml) is performed under local infiltration anesthesia. The fat graft is processed into nano-fat using Tulip GEMS Single-Use NanoTransfer Set. Esophagoscopy with gastroscope is performed and stricture is visually graded (location, length, lumen) and photographed. Then esophageal stricture is biopsied with biopsy forceps and dilated with through-the-scope CRE(controlled radial expansion) balloon dilator. Prepared fat graft is injected beneath the mucosal layer at the stricture site (volume of 0,1-0,5 ml) at three locations. Patients are either discharged after two hours follow up or admitted to the inpatient ward, depending on the pre- and postoperative condition.
Patients are contacted by phone 1 week after the operation. Post-operative symptoms are recorded and patients are requested to contact the researcher if needed. Patient records are screened for pre- and postoperative symptoms, medication, long term illnesses and possible postoperative contacts to hospital.
Follow-up esophagoscopy is performed and biopsies taken three and 12 months after the first operation. The stricture site is visually graded and photographed. The Eckardt score is recorded. If the patient has problems with eating (Eckardt score dysphagia points more than 1) the stricture is re-dilated and fat grafting repeated.
If a patient would have recurrence in dysphagia before three months the patient is treated according to normal routine and dilation is repeated earlier.
The follow-up time is 12 months counting from the last fat grafting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Esophageal stricture patients | Experimental | Procedure: Stricture dilation with CRE balloon, Procedure: Autologous fat graftingPatients suffering from benign esophageal stricture are treated with through-the scope CRE dilation balloon. Free fat graft is gathered from the abdominal subcutaneous fat. Fat graft is prepared and injected to the stricture site. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Esophageal stricture that has re-occurred at least once
Key exclusion criteria (1 listed)
- Malignant etiology of esophageal stricture
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 |
|---|---|---|
| Stricture dilation with CRE balloonEsophageal stricture is treated by dilation therapy. | Procedure or surgery | Esophageal stricture patients |
| Autologous fat graftingAutologous fat graft is gathered and injected to stricture | Procedure or surgery | Esophageal stricture patients |
Primary outcome
Incidence of Treatment-Emergent Adverse Events at 3 months
Time frame: 3 months
Types, severity and probability of procedure related adverse events
Incidence of Treatment-Emergent Adverse Events at 12 months
Time frame: 12 months
Types, severity and probability of procedure related adverse events
6 secondary outcomes
Change from Baseline Eckardt score at 3 months
Time frame: 3 months
Change from Baseline Eckardt-score at 12 months
Time frame: 12 months
Change from Baseline Stricture Lumen diameter at 3 months
Time frame: 3 months
Change from Baseline Stricture Lumen diameter at 12 months
Time frame: 12 months
Change from Baseline Stricture length at 3 months
Time frame: 3 months
Change from Baseline Stricture length at 12 months
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 2 Mar 2021.
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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.
Pauliina Hartiala, Surgeon study director
Turku University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Stricture dilation with CRE balloon and Autologous fat grafting in people with Esophageal Stricture and Fat Graft, run by Hannes Kortekangas.
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 1 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: status not confirmed, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Hannes A Kortekangas, Surgeon (+35823139192, hannes.kortekangas@tyks.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events at 3 months (time frame: 3 months). The study lists 2 primary outcomes in all. 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 2 Mar 2021.