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

Esophageal Stricture Clinical Trial

— ESOGRAFT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04221867
• Other study ID #: ESOGRAFT
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 15, 2021
• Est. completion date: March 1, 2023

Study information

• Verified date: February 2021
• Source: Turku University Hospital
• Contact: Hannes A Kortekangas, Surgeon
• Phone: +35823139192
• Email: hannes.kortekangas[@]tyks.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Esophageal stricture that has re-occurred at least once

Exclusion Criteria:

• Malignant etiology of esophageal stricture

Related Conditions & MeSH terms

• Constriction, Pathologic
• Esophageal Stenosis
• Esophageal Stricture
• Fat Graft

Intervention

Procedure:
• Stricture dilation with CRE balloon
Esophageal stricture is treated by dilation therapy.
• Autologous fat grafting
Autologous fat graft is gathered and injected to stricture

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hannes Kortekangas

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events at 3 months	Types, severity and probability of procedure related adverse events	3 months
Primary	Incidence of Treatment-Emergent Adverse Events at 12 months	Types, severity and probability of procedure related adverse events	12 months
Secondary	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
Secondary	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
Secondary	Change from Baseline Stricture Lumen diameter at 3 months	Stricture photographed and lumen diameter measurement. Unit: closed biopsy forceps diameter.	3 months
Secondary	Change from Baseline Stricture Lumen diameter at 12 months	Stricture photographed and lumen diameter measurement. Unit: closed biopsy forceps diameter.	12 months
Secondary	Change from Baseline Stricture length at 3 months	Stricture length measured using shaft of biopsy forceps. Unit: mm.	3 months
Secondary	Change from Baseline Stricture length at 12 months	Stricture length measured using shaft of biopsy forceps. Unit: mm.	12 months