Safety and feasibility of Outpatient Full-Thickness resection for colorectal lesions: The SOFT study

Aims Endoscopic full-thickness resection (EFTR) is emerging as an effective and safe technique for difficult colorectal lesions, offering a valid alternative to surgery for “no-lifting” lesions, commonly performed during hospitalization. The recent outbreak of COVID-19 compelled endoscopic units to admit only patients for urgent endoscopic procedures, postponing hospitalization for elective nonlife-saving procedures such as EFTR. Moreover, there has been growing experience supporting the safety and effectiveness of EFTR. We aim to retrospectively evaluate the safety and feasibility of non-exposed EFTR as an outpatient procedure in the main Italian centers.

Methods We conducted a nationwide multicentre retrospective study, including centers with demonstrated>5 years of expertise in non-exposed EFTR. The study is conceived as a collection of all consecutive cases of non-exposed colorectal EFTR for lesions<30 mm with “no lifting sign” or located in difficult anatomic locations, performed since 2018 in outpatient or hospital settings. “Hospital setting” is a hospital admission for clinical monitoring, including at least a one-night stay. “Outpatient setting” is defined as clinical monitoring that does not require the patient to stay overnight. The primary outcome was to compare the safety (defined as any adverse event rate) of EFTR between the hospital and outpatient groups. The Adverse Events (AEs) were classified as follows: mild (not requiring medical or endoscopic intervention), moderate (requiring medical or endoscopic intervention), and severe (requiring surgical therapy and/or potentially life-threatening.). Secondary outcomes were clinical success (histologically confirmed full-thickness R0 resection), technical success (ability to reach the target lesion), and recurrence rate at 12 months.

Results One hundred-sixty-eight patients, 94 (55%) hospital setting, and 74 (45%) outpatient setting were included in the analysis. The two study groups were comparable for gender (male 59.6% vs 54.1%, p=0.47) and age (71.4±12.1 vs 68.4±11.1, p=0.1). There were no statistically significant differences among the groups for antiplatelet/coagulant therapy, lesion location, morphology, and size. No statistically significant differences in terms of mild AEs (2.1% vs 5.4%, p=0.41), moderate AEs (9.6% vs 9.5%, p=0.98), and severe AEs (6.4% vs 1.4% p=0.14) rate, technical success (96.8% vs 100%, p=0.26), R0 resection rate (89.3% vs 87.8%, p=0.78), technical difficulties (19.2% vs 27%, p=0.23) and recurrence rate at 12 months (7.5% vs 4.2%, p=0.52) were observed between the two groups [1] [2].

Conclusions EFTR performed in an outpatient setting is safe and feasible with a similar AEs and success rate to EFTR performed in hospital setting. Thus, strict self-observation with the possibility to access directly to the endoscopic service allows adequate and cost-effective management for the post-EFTR AEs. Prospective studies are needed to confirm these results and demonstrate the safety and effectiveness of EFTR in this setting.

• References

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• 2 Schmidt A, Beyna T, Schumacher B, Meining A, Richter-Schrag HJ, Messmann H, Neuhaus H, Albers D, Birk M, Thimme R, Probst A, Faehndrich M, Frieling T, Goetz M, Riecken B, Caca K. Colonoscopic full-thickness resection using an over-the-scope device: a prospective multicentre study in various indications. Gut 2018; 67: 1280-1289