Introduction

Adequate bowel cleansing is essential for colonoscopy quality. A novel 1L polyethylene glycol plus ascorbate (1L PEG+ASC) solution has been recently introduced. Nevertheless, the efficacy of 1L PEG+ASC as compared to that of high-volume bowel preparation in both inpatients and outpatients is still unclear.

Aims & Methods

This single-blinded, non-inferiority RCT aims to compare the efficacy, safety, and tolerability of 1L PEG+ASC versus a high-volume 4L PEG-based preparation in both inpatients and outpatients. The primary endpoint was the overall cleansing success. Secondary endpoints were excellent cleansing and high-quality cleansing of the right colon, as well as lesions detection rate, patient compliance, and safety.

Results

Overall, 478 patients (mean age 59.3 ± 14.9 years) were randomized to 1L PEG+ASC (N = 236) or 4L PEG (N = 242). The 1L PEG+ASC showed higher cleansing success rate as compared to 4L PEG preparation (91.8% vs 83.6%; OR = 2.207; 95% CI: 1.2-4.0; P = 0.01), as well as higher excellent cleansing (39.1% vs 27.7; OR, 1.67; 95% CI: 1.1-2.5; P= 0.001) and high-quality cleansing of the right colon (52.3% vs 38.5%; OR, 1.75; 95% CI: 1.194-2.564; P = 0.004). As compared to the high volume, 1L PEG+ASC achieved a higher cleansing success rate in out-patients (96.3%% vs 88.6%; P = 0.018) and a similar success among the in-patients (84.7% vs 76.7%; P = 0.18). No significant differences in colonoscopy performance, including caecal intubation rate (97.3% vs 96.2%, P= 0.5), withdrawal time (9.6 ± 3.2 vs 9.9 ± 4.1, P=0.3) and adenoma detection rate (25.5% vs 23.5%, P= 0.6) were found between 1L PEG+ASC and 4L PEG preparation, respectively. The 1L PEG+ASC and 4L PEG preparation did not differ significantly in terms of tolerability, as documented by the similar rate of patients reporting total adverse events (AEs) (75.1% vs 77.8%, P = 0.5), mild AEs (68.0% vs 70.3%, P = 0.6) and moderate to severe AEs (32.0% vs 29.5%, P = 0.6) after bowel preparation.

Conclusion

Data of this randomized study showed that quality of bowel preparation for colonoscopy achieved with 1L PEG+ASC solution is not inferior as compared to that of 4L PEG. No differences in the tolerability and safety were detected. (Registration/protocol: EudraCT Number 2018-004543-24).

Disclosure

Roberto Vassallo received consultation fees from AlfaSigma and Norgine. Marcello Maida and Roberto Di Mitri served as advisory board member and received lecture grants from Norgine. Other authors have no proprietary, financial, professional or other personal interest of any nature or kind in any product, service and/or company that could be construed as influencing the position presented in, or the review of this manuscript.

Introduction

In recent years, propofol has become the sedative of choice for gastrointestinal endoscopy. Despite large cohort studies demonstrating its safety and effectiveness, the adoption of Non-Anesthesiologist Administration of Propofol (NAAP) in clinical practice still faces numerous challenges, both in Europe and globally. Consequently, propofol-based sedation remains largely in the hands of anesthesia professionals.

Aims & Methods

This study was conducted in two phases. Initially, a preliminary analysis was carried out to compare adverse event (AE) rates between NAAP and Anesthesiologist Administration of Propofol (AAP) at a tertiary academic center (San Raffaele Hospital, Milan, Italy). In the second phase, potential cost savings from implementing NAAP over AAP at the hospital, local, and national levels were examined.
Propensity score matching (PSM), based on age, sex, body mass index (BMI), and ASA Physical Status Classification System score, was used to compare the two cohorts. A 3-year budget impact model (BIM) was implemented based on the annual volume of outpatient endoscopy procedures performed at San Raffaele Hospital and estimates of the Italian adult population by Italian National Institute of Statistics (ISTAT).

Results

From May 2019 to October 2021, 2,721 patients who underwent esophagogastroduodenoscopy (EGD) (2,439 NAAP and 282 AAP) and 2,748 who underwent colonoscopy (2,491 NAAP and 257 AAP) in outpatient setting were enrolled. Only diagnostic procedures were included. After PSM, the EGD cohort included 282 patients under NAAP and 188 under AAP, while the colonoscopy cohort consisted of 256 patients under NAAP and 174 under AAP. No significant differences in AE rates were observed between the groups in both the EGD (overall: NAAP 1.1% vs AAP 0.8%, p=0.815; after PSM: NAAP 0.4% vs. AAP 1.0%, p=0.452) and colonoscopy cohorts (overall: NAAP 1.7% vs AAP 3.5%, p=0.202; after PSM: NAAP 3.5% vs. AAP 0.6%, p=0.249). All AEs were managed without leading to major or long-term sequelae.
According to the BIM, a complete implementation of NAAP instead of AAP for patients classified as ASA 1 and 2 would lead to financial savings of €851,649 at our hospital, €8.3 million for the Local Health Authority of Milan, €19.8 million for the Lombardy region, and €124.7 million for the Italian National Health System over the triennium 2023-2025.

Conclusion

NAAP is a safe sedation modality for outpatient gastrointestinal endoscopy, with AE rates comparable to those of AAP. Its widespread implementation, at the expense of AAP, could result in savings exceeding €120 million for the Italian National Health System over the triennium 2023-2025.

References

NAAP is a safe sedation modality with AE rates comparable to AAP. The widespread implementation of NAAP, rather than reliance on anesthesiologist-led propofol sedation, could result in savings exceeding €120 million for the Italian National Health System over the triennium 2023-2025.

Introduction

The Updated Sydney System recommends reporting the severity of both glandular atrophy (GA) and intestinal metaplasia (IM) as two independent parameters. However, the OLGA system assesses both GA and IM together as part of the same entity which should be reported as an average severity. The OLGIM system is based on the IM severity recommended by the updated Sydney system. Thus, the final OLGIM score can be estimated by any clinician. Currently, no system addresses the severity of both GA and IM as they are reported following the updated Sydney recommendation.

Aims & Methods

This study aimed to assess the utility of a new system, OLGIMA (Operative Link on Gastric IM and GA assessment), as a tool to identify patients at higher risk for GC in daily practice.
Consecutive diagnostic UGI endoscopies performed for any indications in patients older than 18 years old were recorded prospectively in 21 Spanish hospitals between April 2021 and July 2023. Protocolized gastric biopsies were taken according to the Updated Sydney consensus. We excluded patients with dysplasia, any malignancy, suspicion of autoimmune chronic atrophic gastritis, and lack of histological data. The severity of both GA and IM was assessed in the antrum (including incisura) and corpus following the updated Sydney system. After that, we considered the most advanced severity (none:0; mild:1; moderate:2; marked:3) provided for any of them in each of the two topographical areas. Then, the OLGIMA staging was done according to the same methodology used by the OLGA and OLGIM systems.

Results

A total of 998 patients were included. The median age was 57 (IQR 46 - 67), and 64% were women. Hp infection was identified in 334 (35%) patients (19% active infection and 16% eradicated). GA was identified in 192 (19.2%) patients which was limited to the antrum in 113 (11.3%) cases and extensive in 79 (7.9%). IM was identified in 159 (15.9%) patients which was limited to the antrum in 114 (11.4%) cases and extensive in 45 (4.5%). According to IM severity, 27 (2.7%) patients were OLGIM III/IV. According to GA severity, 22 (2.2%) patients were significantly extensive. The OLGIM system would have missed 12 (1.2%) patients with GA at higher risk. Considering both criteria, we would have detected 39 (3.9%) patients at higher risk in total (17 OLGIM III-IV, 12 extensive significative GA, and 10 both OLGIM III-IV and extensive significative GA). The new OLGIMA system categorized all 39 (3.9%) patients, OLGIM III-IV and significantly extensive GA, in the high-risk group (OLGIMA III/IV).

Conclusion

The new OLGIMA system (based on the severity of IM and GA recommended by the updated Sydney system) was able to detect patients at higher risk including all cases of OLGIM III/IV and also with advanced GA. The OLGIMA staging is much simpler and it can be estimated by any clinician regardless of whether the biopsy from incisura was taken.

References

Rugge M, Meggio A, Pennelli G et al. Gastritis staging in clinical practice: the OLGA staging system. Gut. 2007;56:631-6
Capelle LG, de Vries AC, Haringsma J et al. The staging of gastritis with the OLGA system by using intestinal metaplasia as an accurate alternative for atrophic gastritis. Gastrointest Endosc. 2010;71:1150-8
Pimentel-Nunes P, Libânio D, Marcos-Pinto R et al. Management of epithelial precancerous conditions and lesions in the stomach (MAPS II): European Society of Gastrointestinal Endoscopy (ESGE), European Helicobacter and Microbiota Study Group (EHMSG), European Society of Pathology (ESP), and Sociedade Portuguesa de Endoscopia Digestiva (SPED) guideline update 2019. Endoscopy. 2019;51:365-388.

Introduction

Although Gastric Peroral Endoscopic Myotomy (G-POEM) has shown substantial efficacy in patients with medically refractory gastroparesis (GP), comprehensive long-term data on its effectiveness are lacking.

Aims & Methods

We conducted a systematic review and meta-analysis including observational studies assessing long-term outcomes after G-POEM in patients with refractory GP. Our primary outcome was the pooled rate of clinical success1-year after G-POEM. Secondary outcomes included clinical success rates beyond 1 year, and the rate of adverse events (AEs).

Results

Fifteen studies, comprising 986 patients with refractory GP undergoing G-POEM, were eligible. The pooled 1 year-success rate was 0.722 (95% CI: 0.56, 0.86, I²=94.92%). In the subgroup analysis, which included only studies enrolling patients with 4-hour Postprandial Gastric Residual (PGR) ≥ 10%, the clinical success rate was 0.610 (95% CI: 0.526, 0.709, I²=46.66%). The pooled success rates at 2 and 3 years calculated on followed-up patients were 0.861 (95% CI: 0.72, 0.96, I²=85.11%) and 0.838 (95% CI: 0.56, 0.99, I²=91.90%), respectively. In the subgroup analysis including studies that did not exclude non-responding patients from follow-up, the 2-year pooled success rate was 0.838 (95% CI: 0.60, 0.98, I²=89.49%). The pooled rate of AEs was 0.092 (95% CI: 0.06, 0.13, I²=81.35%), specifically 0.078 mild and 0.014 moderate AEs, according to the American Society for Gastrointestinal Endoscopy classification.

Conclusion

G-POEM is a safe procedure with 1-year success in more than 2/3 of treated cases and substantial benefit also at 2 and 3-years follow-ups. Future studies with strict patient selection and uniform outcome definitions are warranted.

Introduction

Anastomotic leak remains one of the most critical complication after Ivor-Lewis esophagectomy [1][2]. While intra-cavitary approach for Endoscopic Vacuum Therapy (EVT) has been proved effective for the treatment of large dehiscences [3], no data exist comparing intraluminal EVT and Self-expanding Metal Stent (SEMS) in the management of non-large (<3 cm) anastomotic dehiscences.

Aims & Methods

In this matched-at-enrollment case-control study (1:1), we included patients who received EVT and SEMS for non-large (<3 cm) anastomotic dehiscences after oncologic Ivor-Lewis esophagectomy between May 2014 and July 2022. The primary outcome was successful closure of the leak. Exclusion criteria were: anastomotic dehiscences > 3 cm, early (≤ 2 days) and late (4 weeks) diagnosis after surgery, severe gastric conduit necrosis, sepsis/septic shock at diagnosis.

Results

Overall, 22 patients treated with EVT and 22 treated with SEMS, were matched by age (p=0.070), sex (p=0.262), BMI (0,247), American Society of Anesthesiologists (ASA) score (p=0.386), neoadiuvant radio/chemotherapy (p=0.15), dehiscence diagnosis modality (0.761), defect type (leak or fistula) (p=1.00), PCR values (p=0.103) surgical re-intervention before endoscopic treatment (p=0.472) and leak size (p=0.931). EVT and SEMS revealed no difference in leak resolution (90.9% vs 72.7%, respectively; p=0.21), whereas EVT group was associated with higher number of procedures (4.41 vs 2.18, p= 0.05, respectively). Concerning adverse events (AE’s), both EVT and SEMS showed no statistical difference in AE’s rates (p=0.61). Overall outcomes of endoscopic procedures are shown in Table 1.

Conclusion

EVT and SEMS has shown similar efficacy outcomes in the treatment of non-large (< 3 cm) anastomotic defects after Ivor-Lewis esophagectomy. Prospective comparison data are needed to validated these findings.

References

1. Seesing MFJ, Gisbertz SS, Goense L, van Hillegersberg R, Kroon HM, Lagarde SM, Ruurda JP, Slaman AE, van Berge Henegouwen MI, Wijnhoven BPL (2017) A Propensity Score Matched Analysis of Open Versus Minimally Invasive Transthoracic Esophagectomy in the Netherlands. Ann Surg 266: 839–846
2. Kassis ES, Kosinski AS, Ross P Jr, Koppes KE, Donahue JM, Daniel VC (2013) Predictors of anastomotic leak after esophagectomy: an analysis of the society of thoracic surgeons general thoracic database. Ann Thorac Surg 96: 1919–1926
3. Zhang CC, Liesenfeld L, Klotz R, Koschny R, Rupp C, Schmidt T, Diener MK, Müller-Stich BP, Hackert T, Sauer P, Büchler MW, Schaible A (2021) Feasibility, effectiveness, and safety of endoscopic vacuum therapy for intrathoracic anastomotic leakage following transthoracic esophageal resection. BMC Gastroenterol 21:72

Disclosure

Prof. Silvio Danese has served as a speaker, consultant, and advisory board member for Schering-Plough, AbbVie, Actelion, Alphawasserman, AstraZeneca, Cellerix, Cosmo Pharmaceuticals, Ferring, Genentech, Grunenthal, Johnson and Johnson, Millenium Takeda, MSD, Nikkiso Europe GmbH, Novo Nordisk, Nycomed, Pfizer, Pharmacosmos, UCB Pharma and Vifor. The other authors declare no conflict of interests. Dr Francesco Vito Mandarino, Dr Alberto Barchi, Dr Lorenzo Leone, Dr Lorella Fanti, Dr Francesco Azzolini, Dr Edi Viale, Dr Dario Esposito, Dr Noemi Salmeri, Dr Francesco Puccetti, Dr Lavinia Barbieri, Dr Andrea Cossu, Dr Elio Treppiedi, Dr Ugo Elmore and Prof Riccardo Rosati have no conflict of interest to disclose.

Introduction

Currently, we can reliably and non-invasively determine steatosis and liver fibrosis by CAP/ATI/PDFF and ET/2D-SWE/MRE, respectively. However, it is not possible to accurately determine the inflammatory component without biopsy. In addition to 2D-SWE and Attenuation Imaging, some new multiparametric US devices incorporate the tissue viscosity-dependent 2D-SWD dispersion slope parameter. The liver is not a purely elastic but a viscoelastic organ, so that 2D-SWD measurement could be useful in the determination of necroinflammation. Our aim was to evaluate the correlation of SWD with the inflammatory component of MAFLD.

Aims & Methods

Prospective study. Immediately prior to liver biopsy (Tru-Cut 16G) in patients with suspected MAFLD, SWD (Canon Aplio i800) was performed. Exclusion criteria were: liver biopsy length <1.5 cm/<11 portal tracts, absence of MAFLD on final biopsy result (steatosis <5%). MAFLD was classified according to NASH-CRN. Normally distributed quantitative variables were described using the mean; otherwise, the median was calculated.

Results

112 patients were included: age 53 years, women 55%, BMI 30.9 kg/m², diabetes 39%, GPT 62 U/L. Biopsy: 2.5 cm, 14 portal spaces. Fibrosis distribution was: F0 53 (46%), F1/F2 37 (32%), F3/F4 25 (22%). Steatosis distribution was: S1 35 (34%), S2 30 (29%), S3 39 (37%). Steatohepatitis: definite 52 (45%), absent 47 (41%), indeterminate 16 (14%). SWD values showed statistically significant differences between patients without steatohepatitis/indeterminate vs. steatohepatitis (13 (m/s)/KHz vs. 13.750 (m/s)/KHz; p=0.015). A positive linear correlation was also observed between SWD and NAS score (rho = 0.216; p=0.028). For the lobular inflammation component, a value of 14.5 (m/s)/KHz had Esp 89.5%, PPV 93.1%, while 10.5 (m/s)/KHz had Sens 90.5%, NPV 80.9%.

Conclusion

The SWD dispersion parameter determined by mulparametric ultrasound could be useful in the non-invasive assessment of liver inflammation and the diagnosis of steatohepatitis in MAFLD patients.