For patients with advanced gastric cancer (GC) without metastasis, gastrectomy in combination with chemotherapy is generally recommended. Some patients are too frail for such invasive treatment because of old age or comorbidities. In the LE-RACUS trial, we are testing the feasibility of Laparoscopic and Endoscopic Cooperative Surgery (LECS) as a less invasive treatment option. During the LECS procedure the tumor is first marked from the inside with an endoscopic knife, followed by perforation of the gastric wall and laparoscopic removal under endoscopic visualization. The current evidence of LECS for advanced GC is based solely on case reports, as no prospective or retrospective studies have been published. Here, we are reporting on the outcomes of the first four patients of the trial. 

A single-center prospective phase 1 trial. Patients with cT2-4aN0M0 GC Borrman type 1-2 < 5 cm, or type 3 < 2 cm are considered for inclusion if they have been tumor board assessed as not fit for standard surgery. Exclusion criteria are Borrman type 4 and tumors close to the cardia. The primary objective is the safety of LECS, defined as Clavien-Dindo score ≥ III. The secondary objectives are any complications, postoperative bleeding or perforation, operation time, radicality, 30-day and in-hospital mortality, hospital stay.

To date, four patients have been enrolled. The median age was 88 years (range 75-95), with a median Charlson comorbidity index of 6.5 (range 5-10). Median tumor size was 3.5 cm (range 2-5), located in the fundus (n=2), body (n=1), and antrum (n=1). All patients underwent the LECS procedure successfully. Postoperative events included one case of intra-abdominal abscess requiring percutaneous drainage and one case of fever on day 3, treated with antibiotics. No cases of postoperative bleeding, perforation, or other major complications were observed during follow-up. The median operation time was 186.5 minutes (range 171-230), and the median hospital stay was 6.5 days (range 3-19). There were no perioperative deaths. Pathology revealed T1am2, T1bSm1, T2 and T4 adenocarcinoma, two of which were tubular subtype, one tubular/papillary type and one signet ring cell type. Radical resection was achieved in 3 out of 4 cases. 

The preliminary results from the LE-RACUS trial indicate that LECS is a feasible option for patients with non-metastatic advanced gastric cancer who are considered too frail for standard surgery. However, the complete trial results are warranted for better assessment of this innovative approach.