Feasibility and Therapeutic Potential of Free Fat Grafts in the Treatment of Esophageal Strictures (ESOGRAFT)

Study Overview
=================
Brief 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.

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.

Official Title
-----------------
Feasibility and Therapeutic Potential of Free Fat Grafts in the Treatment of Esophageal Strictures

Conditions
-----------------
Esophageal Stricture, Fat Graft

Intervention / Treatment
-----------------
* Procedure: Stricture dilation with CRE balloon
* Procedure: Autologous fat grafting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Esophageal stricture that has re-occurred at least once Exclusion Criteria: Malignant etiology of esophageal stricture

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Esophageal stricture patients<br>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. | Procedure: Stricture dilation with CRE balloon<br>* Esophageal stricture is treated by dilation therapy.<br>Procedure: Autologous fat grafting<br>* Autologous fat graft is gathered and injected to stricture<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events at 3 months | Types, severity and probability of procedure related adverse events | 3 months | 
| Incidence of Treatment-Emergent Adverse Events at 12 months | Types, severity and probability of procedure related adverse events | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 12 months | 
| Change from Baseline Stricture Lumen diameter at 3 months | Stricture photographed and lumen diameter measurement. Unit: closed biopsy forceps diameter. | 3 months | 
| Change from Baseline Stricture Lumen diameter at 12 months | Stricture photographed and lumen diameter measurement. Unit: closed biopsy forceps diameter. | 12 months | 
| Change from Baseline Stricture length at 3 months | Stricture length measured using shaft of biopsy forceps. Unit: mm. | 3 months | 
| Change from Baseline Stricture length at 12 months | Stricture length measured using shaft of biopsy forceps. Unit: mm. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Esophageal Stricture, Fat Graft, Dilation