Feasibility and Therapeutic Potential of Free Fat Grafts in the Treatment of Esophageal Strictures (ESOGRAFT)
NCT ID: NCT04221867
Last Updated: 2021-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
20 participants
INTERVENTIONAL
2021-08-15
2023-03-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pragmatic Approach To Esophageal Dilation
NCT04542551
Esophageal Dysmotility - Prospective Study Evaluating Methods for Esophageal Dilation
NCT03604523
Injection Versus Suture Repair of Laryngeal Clefts
NCT07057258
Anesthetic to Reduce Dysphagia After Anterior Cervical Discectomy and Fusion Surgery
NCT02376205
Esophagogastric Junction Distensibility During Hiatal Hernia Repair
NCT04450628
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Esophageal stricture patients
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.
Stricture dilation with CRE balloon
Esophageal stricture is treated by dilation therapy.
Autologous fat grafting
Autologous fat graft is gathered and injected to stricture
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Stricture dilation with CRE balloon
Esophageal stricture is treated by dilation therapy.
Autologous fat grafting
Autologous fat graft is gathered and injected to stricture
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
18 Years
99 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hannes Kortekangas
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hannes Kortekangas
Gastrointestinal surgeon / Consultant in Division of Gastrointestinal Surgery
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pauliina Hartiala, Surgeon
Role: STUDY_DIRECTOR
Turku University Hospital
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ESOGRAFT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.