RESTOREGI Study Benign gastrointestinal fistulas are abnormal communications between the gastrointestinal tract and adjacent organs or the skin. Chronic fistulas are often difficult to treat because of persistent inflammation, fibrosis, impaired vascularity, and defective tissue regeneration. Endoscopic regenerative therapy using mechanically processed autologous total stromal vascular fraction-enriched microfragmented adipose tissue (tSVF-EM) has emerged as a novel therapeutic approach that may promote tissue repair through angiogenesis, immunomodulation, and regenerative signaling.
Although early clinical experience suggests promising healing outcomes, factors predicting successful fistula closure remain poorly understood. The RESTOREGI study is a prospective, single-center observational cohort study designed to identify patient-related, fistula-related, and procedural factors associated with successful healing following endoscopic tSVF-EM therapy in benign gastrointestinal fistulas. The study will also evaluate treatment safety, time to healing, recurrence rates, and the impact of procedural variables on outcomes.
Age ≥18 years
Confirmed benign gastrointestinal fistula involving the luminal gastrointestinal tract
Fistula accessible for endoscopic evaluation and treatment
Planned treatment with endoscopic tSVF-EM therapy, with or without adjunctive endoscopic therapies (argon plasma coagulation [APC], tract abrasion/curettage, clips, over-the-scope clips [OTSC], endoscopic suturing, or stent placement)
Perianal fistulas of any aetiology
Inflammatory bowel disease-associated fistulas, including fistulas related to Crohn's disease or ulcerative colitis
Malignancy-related fistulas
Fistulas requiring primary oncologic surgical management
Sequential
Endoscopic tSVF-EM Therapy
Procedure/SurgeryAutologous adipose tissue will be harvested using standard liposuction techniques and mechanically processed to obtain total stromal vascular fraction-enriched microfragmented adipose tissue (tSVF-EM). The processed tissue will be injected endoscopically into the margins and/or tract of benign gastrointestinal fistulas according to institutional regenerative endoscopy protocols. Adjunctive endoscopic therapies, including argon plasma coagulation (APC), fistula tract abrasion or curettage, clips, over-the-scope clips (OTSC), endoscopic suturing, or stent placement, may be performed at the discretion of the treating physician. Repeat tSVF-EM treatment sessions may be undertaken based on clinical response and persistence of the fistula.
Composite Fistula Healing at 6 Months
Composite fistula healing is defined as the simultaneous achievement of: Clinical resolution of the fistula, characterized by the absence of fistula output, drainage, or symptoms attributable to the fistula; and Objective confirmation of closure demonstrated by either: Endoscopic evidence of complete closure of the fistula opening, or Radiological evidence of absence of contrast extravasation or fistulous communication on appropriate imaging studies. Participants meeting both criteria will be classified as having achieved successful fistula healing.
Number of tSVF-EM Treatment Sessions Required for Healing
Total number of endoscopic tSVF-EM treatment sessions required to achieve composite fistula healing.
Time to Fistula Healing
Time from the first tSVF-EM treatment session to achievement of composite fistula healing, defined as clinical resolution of fistula output and objective confirmation of closure by endoscopy or imaging.
Fistula Recurrence Rate
Proportion of participants who develop recurrence of a previously healed fistula, defined as reappearance of clinical drainage and/or objective evidence of fistula reopening after documented healing.
Treatment-Related Adverse Events
Incidence, type, severity, and outcome of adverse events related to adipose tissue harvest, endoscopic intervention, sedation/anesthesia, and delayed infectious complications. Adverse events will be graded according to the ASGE Lexicon classification system.
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