Clinical trial NCT04221867: Feasibility and Therapeutic Potential of Free Fat Grafts in the Treatment of Esophageal Strictures (ESOGRAFT)
Official title: Feasibility and Therapeutic Potential of Free Fat Grafts in the Treatment of Esophageal Strictures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Stricture
Fat Graft
Keywords: Esophageal Stricture
Fat Graft
Dilation
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2020-01-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Esophageal stricture that has re-occurred at least once

Exclusion Criteria:

* Malignant etiology of esophageal stricture

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events at 3 months
timeFrame: 3 months
measure: Incidence of Treatment-Emergent Adverse Events at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Change from Baseline Eckardt score at 3 months
timeFrame: 3 months
measure: Change from Baseline Eckardt-score at 12 months
timeFrame: 12 months
measure: Change from Baseline Stricture Lumen diameter at 3 months
timeFrame: 3 months
measure: Change from Baseline Stricture Lumen diameter at 12 months
timeFrame: 12 months
measure: Change from Baseline Stricture length at 3 months
timeFrame: 3 months
measure: Change from Baseline Stricture length at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Turku University Hospital
name: Pauliina Hartiala, Surgeon
role: STUDY_DIRECTOR
References: