Introduction

Endoscopic gastroplasty (EG) is a minimally invasive endoscopic treatment aimed at reshaping the gastric body to manage obesity. This approach is now applicable across all obesity grades. Currently, three EG techniques are commonly used in clinical practice: endoscopic sleeve gastroplasty (ESG), endoluminal vertical gastroplasty (EVG), and distal primary obesity surgery endoluminal (POSE-2).

Aims & Methods

This randomized, single-center clinical trial (ClinicalTrials.gov NCT04854317) included obese individuals undergoing EG using one of the three methods (ESG, EVG, or POSE-2). A subgroup analysis based on obesity classes was performed to determine which technique yields the most favorable outcomes within each class, aiming to support a more tailored, patient-specific treatment approach for obesity. The primary outcomes assessed were weight loss efficacy, improvement in obesity-related comorbidities, and enhancement of quality of life (QoL) across obesity categories.

Results

Between July 2020 and April 2023, 183 patients with obesity (mean BMI 36.3±2.9 kg/m²; mean age 45±10 years; 89.1% female; 57.4% in class II obesity; hepatic steatosis present in 83%) underwent EG using ESG, EVG, or POSE-2. Follow-up adherence was 56.3% at 6 months, 32.8% at 12 months, and 15.8% at 18 months. At these time points, total body weight loss (TBWL) averaged 15.5±6.0%, 14.5±8.5%, and 17.1±10.2%, respectively, while excess weight loss (EWL) was 39.3±15.5%, 36.7±21.3%, and 43.0±26.6%. No significant differences were observed among the three techniques in either TBWL (p=0.92) or EWL (p=0.93) at 18 months.
When stratified by obesity class, there were no significant differences in TBWL (p=0.92) or EWL (p=0.62) among the techniques. However, analyzing technique performance within each obesity class revealed that POSE-2 was superior in class I obesity (p=0.03 for TBWL; p=0.006 for EWL), but less effective in class III (p=0.003). In contrast, EVG showed the best results in class III (p=0.048 for TBWL; p=0.02 for EWL), but underperformed in class I (p=0.034). No significant differences were noted between techniques in class II obesity. Improvements in fatty liver disease, hypertension, hyperlipidemia, diabetes, and obstructive sleep apnea were noted across all groups. Additionally, QoL, as assessed by the BAROS score, significantly improved over 18 months (p<0.001), with no variation across obesity classes.

Conclusion

Endoscopic gastroplasty proved effective in managing obesity. POSE-2 was most beneficial for patients with class I obesity, while ESG and EVG showed greater efficacy in higher obesity classes during mid-term follow-up. These results may support a more personalized therapeutic strategy for obesity.

Disclosure

Consultant for Apollo Endosurgery, EndoTools Therapeutics and USGI Medical.

Introduction

Scar excision with endoscopic full-thickness resection (eFTR) offers a minimally invasive alternative to completion surgery after incomplete resection of low-risk T1 colorectal cancer (CRC). While this strategy has demonstrated promising technical and short-term results, long-term data on oncological safety are lacking.

Aims & Methods

Consecutive patients undergoing eFTR scar excision after incomplete resection of low-risk T1CRC were selected from the Dutch prospective eFTR registry. Incomplete resection was defined as indeterminate (Rx), tumour-positive (R1, <0.1mm) or <1mm tumour-free (R0) resection margins. Lesions were considered low-risk in absence of lymphovascular invasion, poor tumour differentiation and tumour budding grade 2-3 (if assessed). A retrospective analysis was conducted to evaluate the procedural outcomes, subsequent treatment after eFTR, and surveillance data, including endoscopy, CEA and imaging studies, as outlined by local protocols. Study outcomes included the 3-year locoregional recurrence rate (LRR), distant recurrence rate (DRR), salvageable recurrence rate (SRR), overall survival (OS) and organ preservation rate. The 3-year estimates were calculated using the Kaplan-Meier method. Locoregional recurrence was defined as intramural cancer recurrence and/or locoregional lymph node metastasis. Other cancer recurrence was defined as distant recurrence. Salvageable recurrence was defined as cancer recurrence that could be treated with curative intent.

Results

Out of the 1341 procedures registered in the Dutch prospective eFTR registry between 2015 and 2023, 314 patients met the inclusion criteria (mean age 69 years, 62% male). Initial histology showed Rx/R1 margins in 260/314 (83%) and R0 <1mm in 54/314 (17%). Mean time from initial resection to eFTR was 2 months (SD 2). Macroscopic complete scar excision was achieved in 259/314 (83%) patients. At histology, 36/314 (12%) eFTR specimens had residual cancer (15 low-risk T1CRC, 21 high-risk T1CRC/≥T2CRC). Residual cancer was found in 26/143 (18%) patients after initial piecemeal resection versus 10/171 (6%) after en bloc resection. No residual cancer was found after R0 <1mm (0/54). The R0-resection rate for residual cancer was 25/36 (69%). After eFTR, 30/314 (10%) patients underwent completion surgery, of whom 9/30 (30%) had residual cancer. One patient received adjuvant chemoradiotherapy. Surveillance was initiated in the remaining 283/314 (90%) patients. In the surveillance-only group, 246/283 (87%) had at least one recorded follow-up visit, with a median follow-up time of 36 months (IQR 16-52). Of these, 17/246 (7%) had residual cancer in the eFTR specimen. The 3-year LRR, DRR, SRR and OS for this subgroup (n=17) were 13%, 0%, 100% and 94%, respectively. Of the 229/246 (93%) patients without residual cancer in the scar, 187/229 (82%) had no risk factors at initial histology, while the presence of risk factors could not be reliably assessed in 42/229 (18%). In the low-risk group (n=187), the 3-year LRR, DRR, SRR and OS were 1%, 1%, 99% and 98%, respectively. In the group with indeterminate risk factors (n=42), these were 7%, 3%, 97% and 92%. The overall 3-year organ preservation rate for all 314 eFTR procedures initiated was 87%.

Conclusion

In this analysis of a large Dutch prospective eFTR registry, the use of completion eFTR after incomplete resection of low-risk T1CRC demonstrated excellent 3-year oncological outcomes. However, caution should be exercised if the presence of histological risk factors cannot be adequately assessed. Further prospective studies with strict surveillance are warranted.