6 consecutive T1-ERC patients underwent FTRD application which resulted in complete endoscopic resection in all cases. No complications nor disease recurrence were observed during the 1-year follow-up period.
Soriani P et al., IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy performed a study aiming to assess the feasibility and long-term clinical impact of endoscopic treatment with the FTRD in patients with high-risk malignant rectal polyps = T1 early rectal cancer (T1-ERC). According to Ueno et al. histopathological criteria for high risk malignant polyps are defined as follows: low tumor differentiation grade (G3), Haggitt’s levels (pedunculated polyps) 3-4, Kikuchi’s levels (sessile polyps) sm3, width of submucosal invasion ≥ 4000 µm, depth of submucosal invasion ≥ 2000 µm, positive tumor budding, distance from the excision margin < 1 mm, presence of vascular invasion.
6 consecutive patients (5 men, mean age 63 years, range 51-78 years), who had undergone a rectal EMR within the previous 1-3 months and thereby received the histopathological diagnosis of high risk malignant polyp, were treated with the FTRD System. Previous endoscopic mucosal excision had been incomplete in all cases. Three patients were unfit for surgery (ASA IV), the other three patients refused surgery.
The endoscopic full-thickness resection was technically feasible in all cases within 8-15 minutes. No immediate or late complications occurred. All patients could be discharged home within the following 24 hours. The histopathologic analysis performed on the en-bloc-resected specimen demonstrated a complete endoscopic resection in all patients. During follow-up, all patients underwent an oncologic work-up with endoscopy, CT scan, and rectal EUS every 6 months. All patients were in oncologic remission after a median follow-up of 12 months (range 12-18 months) without any radio- or chemotherapy. One patient died from cardiac failure at the 8th month of follow-up after showing no sign of disease recurrence at the 6-month oncological work-up.
The authors concluded that this study provides initial evidence in favor of the FTRD System as therapeutic option for T1 early rectal cancer in patients either unfit for surgery or refusing the standard surgical approach.
A full-length demonstrative video as well as high resolution endoscopic images displaying the original rectal lesions, the EFTR procedures, and the follow-up have been published at Endoscopy International Open: https://doi.org/10.1055/s-0043-118657.
Endoscopic full-thickness resection for T1 early rectal cancer: a case series and video report.
Soriani P, Tontini GE, Neumann H, de Nucci G, De Toma D, Bruni B, Vavassori S, Pastorelli L, Vecchi M, Lagoussis P.
Endoscopy International Open 2017; 05:E1081-E1086.
Risk factors for an adverse outcome in early invasive colorectal carcinoma.
Ueno H, Mochizuki H, Hashiguchi Y et al.
Gastroenterology 2004; 127: 385 – 394.