RESTOREGI Study: Regenerative Endoscopic Stromal Therapy: Outcomes and Risk Factor Evaluation in GI Fistulas (RESTORE-GI)
PROSPECTIVE RISK FACTOR ANALYSIS OF CLINICAL OUTCOMES FOLLOWING ENDOSCOPIC tSVF-em THERAPY FOR BENIGN GASTROINTESTINAL FISTULAS - RESTOREGI Study
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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Benign gastrointestinal fistulas are abnormal communications between the gastrointestinal tract and adjacent organs or the skin that can result in significant morbidity, prolonged hospitalization, impaired quality of life, and repeated therapeutic interventions. Chronic fistulas are characterized by persistent inflammation, fibrosis, impaired perfusion, and defective tissue regeneration, all of which may contribute to failure of conventional closure techniques and recurrent disease.
Endoscopic regenerative therapy using autologous total stromal vascular fraction-enriched microfragmented adipose tissue (tSVF-EM) has emerged as a novel therapeutic approach for the management of complex gastrointestinal defects. Following adipose tissue harvest and mechanical processing, tSVF-EM contains a heterogeneous population of stromal and regenerative cells, extracellular matrix components, and bioactive factors that may promote angiogenesis, immunomodulation, tissue remodeling, and wound healing. Endoscopic delivery of this material directly into the fistula margins aims to create a biologically favorable environment for durable tissue repair.
Early clinical experience with regenerative endoscopic therapies has demonstrated technical feasibility and encouraging healing outcomes in selected patients with benign gastrointestinal fistulas. However, considerable variability in treatment response exists, and factors associated with successful healing remain poorly understood. Improved understanding of patient-related, fistula-related, and procedural determinants of treatment success may facilitate better patient selection, optimize procedural planning, guide the use of adjunctive therapies, and improve overall clinical outcomes.
The RESTOREGI study is a prospective, single-center, real-world cohort study designed to evaluate clinical outcomes following endoscopic tSVF-EM therapy in patients with benign gastrointestinal fistulas. Standardised data will be collected regarding patient characteristics, fistula anatomy and etiology, inflammatory and nutritional status, and procedural factors associated with regenerative endotherapy. The study is intended as an exploratory, hypothesis-generating investigation to identify clinically meaningful factors associated with fistula healing and to establish prospective safety and effectiveness data in this emerging field of regenerative endoscopy.
Findings from this study are expected to provide foundational evidence for future multicenter studies and contribute to the development of evidence-based patient selection and treatment strategies for regenerative management of benign gastrointestinal fistulas.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Goutham K Katukuri, MBBS, MD, DM
- Número de telefone: +919902305703
- E-mail: goutham.mge@gmail.com
Estude backup de contato
- Nome: Rajendra Patel, MBBS, MD, DM
- Número de telefone: +918152049069
- E-mail: doc.rajendrapatel@gmail.com
Locais de estudo
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Telangana
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Hyderabad, Telangana, Índia, 500075
- AIG Hospitals
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Contato:
- Nageshwar R Duvvur, MBBS, MD, DM
- Número de telefone: +914042444222
- E-mail: aigindia@yahoo.co.in
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Investigador principal:
- Goutham R Katukuri, MBBS, MD, DM
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- 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)
- Ability and willingness to provide written informed consent
- Willingness to comply with scheduled follow-up visits and study assessments
Exclusion Criteria:
- 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
- Uncontrolled sepsis or undrained abscess at baseline (patients may become eligible following adequate drainage and clinical stabilisation)
- Contraindication to adipose tissue harvest, sedation, anaesthesia, or therapeutic endoscopy
- Pregnancy or lactation
- Severe coagulopathy not correctable prior to intervention
- Inability to provide informed consent
- Anticipated inability to complete study follow-up
- Participation in another interventional study that may influence fistula healing outcomes
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: N / D
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Endoscopic tSVF-EM Therapy for Benign Gastrointestinal Fistulas
Participants with benign gastrointestinal fistulas will undergo endoscopic regenerative therapy using autologous total stromal vascular fraction-enriched microfragmented adipose tissue (tSVF-EM).
Adjunctive endoscopic therapies including argon plasma coagulation, tract abrasion, clipping, over-the-scope clip placement, endoscopic suturing, or stenting may be performed at the discretion of the treating physician.
Repeat tSVF-EM sessions are permitted according to clinical response.
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Autologous 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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Composite Fistula Healing at 6 Months
Prazo: 6 months following the first tSVF-EM treatment session
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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. |
6 months following the first tSVF-EM treatment session
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of tSVF-EM Treatment Sessions Required for Healing
Prazo: Up to 12 months after first treatment session
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Total number of endoscopic tSVF-EM treatment sessions required to achieve composite fistula healing.
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Up to 12 months after first treatment session
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Time to Fistula Healing
Prazo: Up to 12 months after first treatment session
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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.
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Up to 12 months after first treatment session
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Fistula Recurrence Rate
Prazo: 12 months after first treatment session
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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.
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12 months after first treatment session
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Treatment-Related Adverse Events
Prazo: From treatment initiation through 12 months of follow-up
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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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From treatment initiation through 12 months of follow-up
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Overall Clinical Healing Rate
Prazo: 12 months after first treatment session
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Proportion of treated fistulas achieving clinical healing during the study period.
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12 months after first treatment session
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Need for Additional Endoscopic or Surgical Intervention
Prazo: 12 months after first treatment session
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Proportion of participants requiring alternative endoscopic therapies, radiologic interventions, or surgery because of persistent or recurrent fistula despite tSVF-EM therapy.
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12 months after first treatment session
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Goutham R Katukuri, MBBS, MD, DM, AIG Hospitals
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- tSVF-EM; Version:02
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