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.
