FTRD®: international study shows favorable safety profile and efficacy of EFTR in the upper gastrointestinal tract

FTRD application in 56 patients with lesions in the upper GI tract showed a technical success rate of 93 %, a R0-resection rate of 68 % and only mild to moderate adverse events in 21%.

K. Hajifathalian et al., Weill Cornell Medicine, Division of Gastroenterology and Hepatology, New York, NY, USA performed an international multicenter retrospective study aiming to evaluate efficacy and safety of the FTRD System for resection of lesions in the upper gastrointestinal tract.
56 patients who had undergone EFTR with the FTRD System for lesions of the upper GI tract in 13 centers were included. Patients had a mean age of 61 ± 14 years, ten patients were on antithrombotics before the procedure, one patient was on systemic steroids and one patient on immunosuppressive therapy. Four patients (7 %) had a diagnosis of end-stage renal disease, two patients (4%) a cirrhosis, ten patients (18 %) had diabetes, 7 patients (13 %) had congestive heart failure and coronary artery disease and nine patients (16 %) had a malignancy. Pre-procedural indications for EFTR were mesenchymal neoplasms including gastrointestinal stromal tumor (23.4 %), diagnostic full-thickness biopsy (18 %), initial resection of adenocarcinoma (5.9 %), initial resection of neuroendocrine tumor (5.9 %), resection of residual or recurrent adenoma (4.7 %), resection of residual or recurrent neuroendocrine tumor (4.7 %), resection of residual or recurrent mesenchymal neoplasms including GIST (3.5 %), and initial resection of adenoma (2.4 %). The majority of EFTRs was performed in the gastric antrum (38 %), followed by the gastric body (27 %), gastric cardia and fundus (19 %), duodenum (14 %) and esophagus (2 %). The average size of the lesions was 14 mm (range 3 – 33mm). Application of the FTRD was technically successful in 93 % of patients (52/56) leading to complete and partial resection in 43 (77%) and 9 (16 %) patients, respectively. The overall R0-resection rate was 68 % (38/56). A total of 12 (21 %) mild or moderate adverse events occurred. Follow-up endoscopy was reported for 31 patients (55%), on average 88 days after the initial procedure (IQR 68 – 138 days). 30 patients (97 %) did not have any residual or recurrent lesion on endoscopic examination and biopsy in follow-up, while in one patient (3 %) a residual adenoma was found.
The authors concluded that this international experience suggests that application of the FTRD in the upper GI tract is related to a high technical success rate, an acceptable R0-resection rate, and a low risk of adverse events or early recurrence.

Full-thickness resection device (FTRD) for treatment of upper gastrointestinal tract lesions: the first international experience
Hajifathalian K, Ichkhanian Y, Dawod Q, Meining A, Schmidt A, Glaser N, Vosoughi K, Diehl DL, Grimm IS, James T, Templeton AW, Samarasena JB, El Hage Chehade N, Lee JG, Chang KJ, Mizrahi M, Barawi M, Irani S, Friedland S, Korc P, Aadam AA, Al-Haddad M, Kowalski TE, Smallfield G, Ginsberg GG, Fukami N, Lajin M, Kumta NA, Tang S, Naga Y, Amateau SK, Kasmin F, Goetz M, Seewald S, Kumbhari V, Ngamruengphong S, Mahdev S, Mukewar S, Sampath K, Carr-Locke DL, Khashab MA, Sharaiha RZ.
Endosc Int Open. 2020 Oct; 8(10): E1291–E1301. doi: 10.1055/a-1216-1439

Produktkachel gastroduodenal FTRD