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TAILORING ENDOSCOPIC GASTROPLASTY FOR PERSONALIZED OBESITY TREATMENT: 18-MONTH RESULTS OF THREE TECHNIQUES ACROSS OBESITY CLASSES

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TAILORING ENDOSCOPIC GASTROPLASTY FOR PERSONALIZED OBESITY TREATMENT: 18-MONTH RESULTS OF THREE TECHNIQUES ACROSS OBESITY CLASSES

Salvatore Francesco Vadalà di Prampero 1, Marco Geraci 2, Valentina Cosseddu 3, Jessica Formichetti 3, Paola Bazzu 3, Chiara Rocchi 3, Marco Massidda 3, Piero Giustacchini 4, Guido Costamagna 1, Milutin Bulajic 1

Affiliations

1 Gemelli Isola Hospital, Roma, Italy

2 La Sapienza University, Rome, Italy

3 Mater Olbia Hospital, Olbia, Italy

4 Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy

Summary

AI Generated

Randomized trial of three endoscopic gastroplasty techniques (ESG, EVG, POSE-2) in 183 obese patients found no overall difference at 18 months, but subgroup analysis suggested POSE-2 was superior in class I obesity while EVG performed best in class III obesity.

At 18 months, total body weight loss averaged 17.1±10.2% and excess weight loss 43.0±26.6%, with no significant difference among ESG, EVG, and POSE-2 overall (p=0.92 for TBWL, p=0.93 for EWL).
POSE-2 was superior in class I obesity (p=0.03 for TBWL; p=0.006 for EWL) but less effective in class III obesity (p=0.003); EVG showed 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 between techniques were found in class II obesity.
Quality of life (BAROS score) significantly improved over 18 months (p<0.001) with no variation across obesity classes, and improvements in fatty liver disease, hypertension, hyperlipidemia, diabetes, and obstructive sleep apnea were noted across all groups.
Follow-up adherence declined from 56.3% at 6 months to 15.8% at 18 months.
The speaker acknowledged in Q&A that no formal power calculation was performed for the subgroup analysis and agreed a second trial would be needed to confirm the obesity class-specific differences.

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Abstract

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.

Event

UEG Week Berlin 2025

Topics

Endoscopy Oesophagus Small Intestine & Nutrition

Submission format

Abstract

Session

Randomised controlled trials in upper GI endoscopy

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Michele Reni

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Duvvur Nageshwar Reddy, Pradeep Mundre

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Abstract

Topics

Endoscopy

Published

2026

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Michele Reni

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Pradeep Mundre

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Abstract

Topics

Small Intestine & Nutrition

Published

2026

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Michele Reni

UEG Podcast Episode

Journal Podcast

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Episode 5: UEG Journal September Spotlight

Mohsan Subhani, Djuna L. Cahen

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Abstract

Published

2025

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Michele Reni

UEG Presentation

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Bariatric surgery: Still the gold standard?

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Bariatric surgery: Still the gold standard?

Herbert Burgos Quiros 1

Affiliations

1 GastroClinica, San Jose, Costa Rica

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Abstract

Event

UEG Week Berlin 2025

Topics

Endoscopy Mechanisms & Personalised Medicine Surgery

Session

Obesity in Pan America

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Michele Reni

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Share via Email Share on Facebook Share on X Share on LinkedIn Share on Bluesky

INTERIM RESULTS FROM NAIAD: A NATIONWIDE STUDY OF ARTIFICIAL INTELLIGENCE IN ADENOMA DETECTION (ANALYSIS FROM THE FIRST 1418 PATIENTS AND 34 COLONOSCOPISTS)

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INTERIM RESULTS FROM NAIAD: A NATIONWIDE STUDY OF ARTIFICIAL INTELLIGENCE IN ADENOMA DETECTION (ANALYSIS FROM THE FIRST 1418 PATIENTS AND 34 COLONOSCOPISTS)

Olaolu Olabintan 1, Olayinka Arimoro 2, Alena Marynina 1, Lee Meng Choong 1, Amyn Haji 1, Shraddha Gulati 3, Andrew Emmanuel 3, Bu Hayee 4

Affiliations

1 King’s College Hospital NHS Foundation Trust, London, United Kingdom

2 University of Calgary, Calgary, Canada

3 King's College Hospital, London, United Kingdom

4 Kings College Hospital, London, United Kingdom

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Abstract

Introduction

The detection and resection of adenomatous polyps during colonoscopy has been shown to be the most effective way to decrease the incidence of colorectal cancer and associated mortality ^{1, 2}, with adenoma detection rate (ADR) being a key quality performance indicator. While higher ADR is associated with lower post-colonoscopy colorectal cancer (PCCRC) rates, the latter varies significantly across the UKand the true ‘baseline’ ADR is unknown ^3,4. Meeting the rising demand for high quality colonoscopy is a significant challenge.
The use of computer assisted detection (CADe) is associated with a significant improvement in ADR across multiple clinical trials^{5, 6}, but real-world performance data is lacking.
We sought to evaluate effect on adenoma detection of implementing CADe in a ‘real-world’ setting, in the largest such study to date.

Aims & Methods

This was a randomised, stepped-wedge, open-label trial, using the GI Genius™ (GIG) module, powered to measure the site effect of CADe. A mix of District General Hospitals (DGH) and Teaching Hospitals (TH) were included, with an emphasis on ‘non-expert’ colonoscopists (lifetime colonoscopy <2000 at study start). ‘Expert’ colonoscopists were eligible (lifetime colonoscopy >2000 and ADR>40%).
Data collection was divided into three, 3-month phases: phase 1, baseline data collection with no CADe; phase 2, the intervention phase, where GIG-CADe was active; phase 3 where GIG-CADe was removed. The endoscopists and procedural information were recorded during the three phases. ADR across all three phases was analysed and compared.
Data will be forthcoming from 29 hospitals (England, Scotland, and Wales), n=124 colonoscopists and n>5000 patients, but we report herein results from the first 8 sites to complete the trial.
All patients undergoing routine (non-BCSP) colonoscopy were eligible, but those having colonoscopy for polyp or IBD surveillance were excluded. The study design was as close to real world practice as possible, with no other changes in procedure or technique.

Results

Across the 8 sites involved (2 TH), there were 34 endoscopists (64.7% non-expert vs 35.3% expert) and 1418 patients (56.43±16.9 years; 49.5% female) eligible for analysis. Comparative results (univariate analysis) through the three study phases are reported in table 1. When adjusted for bowel preparation and the endoscopists’ experience, there was a 9.53% increase in ADR in the CADe group (r²= 0.159; p = 0.0142).

Table 1: The distribution of Adenoma Detection rate across the three phases
	Phase 1 ADR	Phase 2 ADR	Phase 3 ADR	P-Value
Average site	27.6% ± 8.2	35.0% ± 7.8	25.8% ± 8.0	0.036*
Average endoscopist	27.0% ± 18.0	36.0% ± 18.0	26.0% ± 16.0	0.038*
Non-expert	19.0% ± 14.1	35.2% ± 17.2	22.8% ± 12.5	0.001**
Expert	40.0% ± 17.0	36.5% ± 20.5	31.1% ± 19.5	0.460
Male endoscopist	30.5% ± 22.3	28.6% ± 19	25.4% ± 17.6	0.773
Female endoscopist	23.7% ± 14.3	41.3% ± 15.8	26.0% ± 14.2	0.001**

Conclusion

NAIAD is the largest trial of CADe to date and, in this interim analysis, establishes a baseline UK ADR of approximately 27.0%. The use of GIG-CADe is associated with a significant increase in ADR, but this returns to baseline when the device is switched off. Further analysis of our result will inform the implementation of CADe in routine practice.

References

Reference:
1) M.F. Kaminski, J. Regula, E. Kraszewska, et al. Quality indicators for colonoscopy and the risk of interval cancer N Engl J Med, 362 (2010), pp. 1795-1803
2) M.F. Kaminski, P. Wieszczy, M. Rupinski, et al. Increased rate of adenoma detection associates with reduced risk of colorectal cancer and death Gastroenterology, 153 (2017), pp. 98-105
3) Burr NE, Derbyshire E, Taylor J, Whalley S, Subramanian V, Finan P J et al. Variation in post-colonoscopy colorectal cancer across colonoscopy providers in English National Health Service: population based cohort study BMJ 2019; 367: l6090 doi:10.1136/bmj.l6090
4) D.A. Corley, C.D. Jensen, A.R. Marks, et al. Adenoma detection rate and risk of colorectal cancer and death N Engl J Med, 370 (2014), pp. 1298-1306
5) Shaukat A, Lichtenstein DR, Somers SC, Chung DC, et al Computer-Aided Detection Improves Adenomas per Colonoscopy for Screening and Surveillance Colonoscopy: A Randomized Trial. Gastroenterology. 2022 Sep;163(3):732-741. doi: 10.1053/j.gastro.2022.05.028. Epub 2022 May 25. PMID: 35643173.
6) Wang, Pu, et al. "Effect of a deep-learning computer-aided detection system on adenoma detection during colonoscopy (CADe-DB trial): a double-blind randomised study." The lancet Gastroenterology & hepatology 5.4 (2020): 343-351.

Event

UEG Week Berlin 2025

Topics

Endoscopy Colorectal

Submission format

Abstract

Session

Detecting polyps with the help of AI

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

More Like This:

Part 1: Nageshwar Reddy - How endoscopy has changed

Duvvur Nageshwar Reddy

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Pradeep Mundre

Episode 5: UEG Journal September Spotlight

Djuna L. Cahen

Bariatric surgery: Still the gold standard?

Herbert Burgos Quiros

INTERIM RESULTS FROM NAIAD: A NATIONWIDE STUDY OF ARTIFICIAL INTELLIGENCE IN ADENOMA DETECTION (ANALYSIS FROM THE FIRST 1418 PATIENTS AND 34 COLONOSCOPISTS)

Amyn Haji

LONG-TERM OUTCOMES OF EUS-GUIDED GASTROENTEROSTOMY (LONG-RANGE STUDY): A PROSPECTIVE COHORT STUDY TRACKING SYMPTOMS RECURRENCE, REINTERVENTION TIMELINES AND STENT CHANGES OVER TIME

Michele Reni

UEG Presentation

Share via Email Share on Facebook Share on X Share on LinkedIn Share on Bluesky

LONG-TERM OUTCOMES OF EUS-GUIDED GASTROENTEROSTOMY (LONG-RANGE STUDY): A PROSPECTIVE COHORT STUDY TRACKING SYMPTOMS RECURRENCE, REINTERVENTION TIMELINES AND STENT CHANGES OVER TIME

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LONG-TERM OUTCOMES OF EUS-GUIDED GASTROENTEROSTOMY (LONG-RANGE STUDY): A PROSPECTIVE COHORT STUDY TRACKING SYMPTOMS RECURRENCE, REINTERVENTION TIMELINES AND STENT CHANGES OVER TIME

Giuseppe Vanella 1, Francesco Frigo 2, Francesca Perelli 3, Roberto Leone 1, Rukaia Barà 1, Rosa Claudia Stasio 4, Patrick Maisonneuve 5, Stefano Partelli 1, Francesca Aleotti 6, Giulia Orsi 6, Marina Macchini 6, Gianpaolo Balzano 7, Michele Reni 1, Massimo Falconi 8, Gabriele Capurso 1, Paolo Giorgio Arcidiacono 1

Affiliations

1 IRCCS San Raffaele Institute, Milan, Italy|||Vita-Salute San Raffaele University, Milan, Italy

2 IRCCS San Raffaele Institute, Milan, Italy|||ASST Cremona, Cremona, Italy

3 Vita-Salute San Raffaele University, Milan, Italy

4 IRCCS San Raffaele Institute, Milan, Italy|||University of Turin, Turin, Italy

5 IRCCS European Institute of Oncology, Milan, Italy

6 IRCCS San Raffaele Institute, Milan, Italy

7 IRCCS San Raffaele Institute, Milan, Italy|||University of Insubria, Varese, Italy

8 Vita-Salute San Raffaele University, Milan, Italy|||IRCCS San Raffaele Institute, Milan, Italy

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Abstract

Introduction

EUS-guided Gastroenterostomy (EUS-GE) represents a recent breakthrough in therapeutic endosonography, with most existing data derived from retrospective studies focused on short-term technical outcomes. Limited information is available on long-term outcomes, the need for reinterventions and modifications of Lumen Apposing Metal Stents (LAMS) over time.

Aims & Methods

All consecutive EUS-GE performed in a single institution with the Wireless Simplified Technique (WEST) between 2020 and 2024 were enrolled in a prospective registry (PROTECT, ClinicalTrials.gov NCT04813055), with efficacy and safety outcomes assessed every 60 days. The primary outcomes were symptom recurrence after initial clinical success (rate, proportion) and dysfunction-free survival (DyFS) estimated using Kaplan Meier curves. Endoscopic LAMS reassessments were used to calculate the time to first modification of the stent and surrounding tissues, whilst Radiologic imaging was used to estimate the change in stent calibre (linear regression).

Results

164 EUS-GEs (median age 66 [60-74], male 52.4%, malignant indication 99.4% [pancreatic cancer 73.2%, metastatic 58.3%]) were included. A 20 mm LAMS was used in 98.8%, dilated up to 18 mm in 98.8% of cases. Technical and Clinical success rates were 98.8% and 96.3%, respectively. Adverse events (AEs) were registered in 15.2% (procedure-related 6.1%, severe/fatal 3.7%).
Over a median follow-up of 112 [40-190] days, symptom recurrence occurred in 9.1%, but was related to stent dysfunctions in 10/154 (6.5%) cases. Stent dysfunctions happened after a median of 231 [67-321] days from the procedure, all of which (100%) were successfully managed endoscopically. Estimated DyFS at 6 and 12 months was 97.5% and 82.6%, respectively.
Among 38 patients undergoing endoscopic LAMS re-evaluation for different reasons, tissue reactions on the gastric or jejunal side were observed in 34.2% after a median of 190 [33-351] days, and LAMS ingrowth was seen in 13.2% after a median of 421 [250-560] days. A total of 132 CT scans from 75 patients were analysed, with regression analysis revealing a reduction in LAMS diameter of ≈ 0.25 mm + 0.03 every 2 months (F-test p<.0001).

Conclusion

In the natural history of EUS-GE, subclinical LAMS changes and tissue reactions can be frequently detected during follow-up along with a progressive narrowing of LAMS diameter. However, most of these modifications are asymptomatic, with a 6.5% rate of endoscopic reinterventions, all performed successfully. Analysis of these curves may be helpful to plan scheduled reinterventions, especially in cases with benign indication or in long-term survivors.

Event

UEG Week Berlin 2025

Topics

Endoscopy Hepatobiliary Pancreas

Submission format

Abstract

Session

Textbook knowledge and limits of HPB endoscopy

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Part 1: Nageshwar Reddy - How endoscopy has changed

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INTERIM RESULTS FROM NAIAD: A NATIONWIDE STUDY OF ARTIFICIAL INTELLIGENCE IN ADENOMA DETECTION (ANALYSIS FROM THE FIRST 1418 PATIENTS AND 34 COLONOSCOPISTS)

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LONG-TERM OUTCOMES OF EUS-GUIDED GASTROENTEROSTOMY (LONG-RANGE STUDY): A PROSPECTIVE COHORT STUDY TRACKING SYMPTOMS RECURRENCE, REINTERVENTION TIMELINES AND STENT CHANGES OVER TIME

Michele Reni