Regenerative Endoscopy for the treatment of difficult gastrointestinal defects

Aims Gastrointestinal (GI) defects, especially those with inflamed, fibrotic, retracted edges, are often refractory to traditional endoscopic procedures. The endoscopic stromal vascular fraction delivery obtained by mechanical, non-enzymatic emulsification of autologous adipose tissue (tSVFem) may play a pivotal role in this context. The autologous tSVFem has anti-inflammatory and regenerative tissue-promoting effects, with no risk for the patient and no additional production costs, and is easy to deliver endoscopically. This study is aimed at evaluating the efficacy and safety of endoscopic tSVFem injection in treating consecutive patients affected by upper and lower GI defects.

Methods This pilot trial included patients with GI defects approachable by endoscopy, where traditional treatments failed or were unsuitable. The tSVFem was obtained by harvesting fat from the subcutaneous tissue of the patient’s hip, followed by sequential passages through sequential filters and centrifugation. Then, the tSVFem was delivered endoscopically into the submucosa of the 4 quadrants of the fistulous orifice by a 22-G injection. Additional injections through the orifice and suturing were performed for larger defects. The primary outcome was complete defect resolution at follow-ups on days 7-15 and 60. Secondary outcomes included the number of treatments needed, procedure-related adverse events, and recurrences at 60 days.

Results The study included 28 patients, 15 with esophageal defects (2 cervical, 4 middle, 6 distal, 3 cardia; mean diameter 4.6±2.8 mm) and 13 with rectal defects (8 rectovesical, 1 rectourethral, 2 rectovaginal fistula, 2 rectocutaneous; mean diameter 4.5±2.6 m). The mean procedure time for both upper and lower GI fistulas was 45±18 minutes. No intraprocedural or postprocedural adverse events or fistula recurrence occurred. Fourteen out of 15 patients with esophageal defects showed complete resolution after TSVFem injection (10/15 after one injection; 4/15 after two injections). The overall resolution rate for rectal defects was 58% (3/13 after one injection, 4/13 after two injections). The resolution rate for defects with the urinary tract was 44.5%, while for the four defects with other organs, it was 75% [1] [2] [3].

Conclusions These results suggest that endoscopic injection of autologous tSVFem may significantly treat complex esophageal and rectal defects, also communicating with adjacent organs, other than the urinary tract. The technique is low-cost, easily reproducible, and adoptable in any center without advanced technologies or highly skilled staff.

Publication History

Article published online:
27 March 2025

• References

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• 2 Nachira D, Trivisonno A, Costamagna G. et al. Successful Therapy of Esophageal Fistulas by Endoscopic Injection of Emulsified Adipose Tissue Stromal Vascular Fraction. Gastroenterology 2021; 160 (04): 1026-1028
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