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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Esophageal Stricture; Fat Graft
• Intervention / Treatment: Procedure: Stricture dilation with CRE balloon; Procedure: Autologous fat grafting

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hannes A Kortekangas, Surgeon; Phone Number: +35823139192; Email: hannes.kortekangas@tyks.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Esophageal stricture that has re-occurred at least once

Exclusion Criteria:

• Malignant etiology of esophageal stricture

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Procedure: Stricture dilation with CRE balloon; Esophageal stricture is treated by dilation therapy.; Procedure: Autologous fat grafting; Autologous fat graft is gathered and injected to stricture

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

Collaborators and Investigators

• Sponsor: Hannes Kortekangas

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 15, 2021
• Primary Completion (ANTICIPATED): March 1, 2022
• Study Completion (ANTICIPATED): March 1, 2023

Study Registration Dates

• First Submitted: January 6, 2020
• First Submitted That Met QC Criteria: January 6, 2020
• First Posted (ACTUAL): January 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 2, 2021
• Last Update Submitted That Met QC Criteria: February 28, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Dilation; Esophageal Stricture; Fat Graft
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pathological Conditions, Anatomical; Esophageal Diseases; Constriction, Pathologic; Esophageal Stenosis
• Other Study ID Numbers: ESOGRAFT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No