Introduction

It is unclear whether the insertion of an axis-orienting double-pigtail plastic stent (DPS) through biliary lumen-apposing metal stents (LAMS) in EUS-guided choledochoduodenostomy (CDS) improves the stent patency.

Aims & Methods

The aim is to determine whether this technical variant offers a clinical benefit in EUS-guided biliary drainage (CDS-type) for the management of distal malignant biliary obstruction. This is a multicentre, open-label, randomised controlled trial with two parallel groups. The primary endpoint was the rate of recurrent biliary obstruction (RBO), as a stent dysfunction parameter, detected during follow-up. Secondary endpoints: technical and clinical success (reduction in bilirubin >50% within 14days), adverse events, and others.

Results

Between November-2020 and October-2022, 123 patients (pancreatic cancer 85%, palliative status 80%) were screened and 84 with malignant biliary obstruction, and underwent EUS-CDS (rescue after failed ERCP, 62%), were randomised: 44 patients in LAMS group and 40 in LAMS-DPS group. The rate of RBO (29.5 vs 10%; OR 0.26 [IC95% 0.07–0.83],p=0.04) was lower, but with a longer procedure time (30 vs 20-min, p=0.02), in LAMS-DPS-group. Furthermore, less biliary reinterventions (12.5 vs 20.5%, p=0.38), longer time-to-RBO (155.5 vs 51.5 days, p=0.10), and shorter hospital stay (6 vs. 8.5,p=0.06) were encountered in LAMS-DPS group. No differences were found between technical (97 vs. 88%), clinical success (92 vs. 88.8%) and AEs (22.5 vs.11.4%). NCT04595058 ClinicalTrials.gov

Table1: Outcomes (RBO, recurrent biliary obstruction; BRI, biliary reinterventions).

	N – 84	LAMS (N-44)	LAMS-Pigtail (N-40)	OR	p
RBO, n (%)	17 (20.2)	13 (29.5)	4 (10)	0.06(0.07-0.83)	0.04
BRI, n (%)	14 (16.7)	9 (20.5)	5 (12.5)	0.98(0.67-1.98)	0.38
Technical success,%	78 (92.9)	39 (88.6)	39 (97.5)	-	0.20
Clinical Success,%	75 (90.5)	39 (88.6)	37 (92.5)	-	0.71
Hospital stay, days	5.1(3-15.5)	8.5 (4.25-15.5)	6 (3-10)	-	0.06
Adverse Events, n	14 (16.1)	5 (11.4)	9 (22.5)	-	0.243
Related-AEs, n	10 (13.1)	3 (6.8)	8 (20.0)	-	0.11

Conclusion

This trial confirms that CDS with LAMS is an effective technique. The technical strategy of placing a pigtail within the LAMS is associated with a lower risk of RBO, and a non-significant trend of shorter hospital stay.

References

1-Garcia-Sumalla, A., Loras, C., Sanchiz, V. et al. Multicenter study of lumen-apposing metal stents with or without pigtail in endoscopic ultrasound-guided biliary drainage for malignant obstruction—BAMPI TRIAL: an open-label, randomized controlled trial protocol. Trials 2022; 23:181
2-Gornals JB, Consiglieri CF, Bergamino MA. Double pigtail for preventing ascending cholangitis after endoscopic ultrasonography-guided choledochoduodenostomy with lumen-apposing metal stent. Dig Endosc. 2016;28:100.
3-Garcia-Sumalla A, Loras C, Guarner-Argente C, et al. Is a coaxial plastic stent within a lumen-apposing metal stent useful for the management of distal malignant biliary obstruction? Surg Endosc. 2021;35:4873 –81

Disclosure

- A Garcia-Sumalla is a PhD student at the Faculty of Medicine and Health Sciences, University of Barcelona, and this paper is part of his doctoral project.
- Joan B Gornals acts as a PhD Director; is a consultant for Boston Scientific and has received a research grant from this company.
- Manuel Pérez-Miranda is a consultant and speaker for Medtronic, Olympus, Taewoong, and M.I.Tech.
- Enrique Vazquez-Sequeiros is a consultant for Boston Scientific.
Jose Ramon Aparicio is a consultant for Boston Scientific

Introduction

Eosinophilic oesophagitis (EoE) is a chronic, progressive type 2 inflammatory disease. Proton-pump inhibitors (PPIs), swallowed topical corticosteroids (STCs), and elimination diets have been used as standard treatments for EoE patients. However, the real-world evidence (RWE) highlighting disease burden in Europe are limited.

Aims & Methods

To assess disease burden and treatment patterns among adolescent and adult patients with EoE in real-world practice.
Medical records were retrospectively reviewed for patients (aged ≥12 years) who were newly diagnosed with EoE between 1 January 2009 and 31 December 2019 (index) in Germany, France, Spain, and the United Kingdom. Patients with a peak eosinophil (eos) count (PEC) of ≥15 eos/hpf within 90 days of the index date and ≥1 follow-up endoscopy within 24 months of the index date were included. Demographics, clinical features, treatment patterns, and health outcomes were assessed from the 12-month pre-index period to the last medical record entry or death. Disease progression was assessed via physician-defined (based on symptoms, endoscopy findings, histology, need for dilation, and food impaction) and proxy-reported outcomes (dilation performed, strictures, dysphagia, evidence of food impaction, treatment initiation in treatment-naïve patients and switching/augmentation).

Results

Overall, 385 patients were included, with 70.1%–78.1% being male; the mean age was 27.8 to 33.9 years. At EoE diagnosis, the PEC was 35.3–46.1 eos/hpf, the endoscopic appearance of the oesophagus was abnormal in 73.7%–85.6% of patients, and dysphagia was present in 59.8%–82.8% of patients. Most of the patients across all 4 countries were treated with PPIs (61.5%–91.8%), STCs (56.7%–82.3%) and elimination diets (41.4%–55.2%) after EoE diagnosis. Of the patients with available data, abnormal histology (≥15 eos/hpf) was reported in 44.8%–72.0% of patients during the first 5 years after EoE diagnosis. The abnormal endoscopic appearance of the oesophagus was observed in 34.6%–83.3% of patients after approximately 2 years of EoE diagnosis and dysphagia was present in 10.2%–25.0% of patients after 4 years of EoE diagnosis across all 4 countries. While physician-defined disease progression occurred in 6.1%–16.1% of patients, 19.4%–35.1% of patients experienced proxy-reported outcomes of potential disease progression (including oesophageal dilation performed in 10.8%–21.7% of patients) after EoE diagnosis. An overview of patient and clinical characteristics at EoE diagnosis and treatment patterns and disease progression (physician-defined and proxy-reported) after EoE diagnosis across Germany, France, Spain, and the United Kingdom is provided in the Table.

Patient and clinical characteristics at eosinophilic oesophagitis diagnosis	Germany (N=96)	France (N=99)	Spain (N=97)	United Kingdom (N=93)
Male, n (%) / Age, years, mean (standard deviation)	78.1 / 32.0 (14.9)	72.7 / 27.8 (13.4)	70.1 / 32.2 (14.1)	72.0 / 33.9 (13.5)
Peak eosinophil count/ high-power field, mean (standard deviation)	35.3 (29.1)	39.5 (46.3)	46.1 (41.7)	43.3 (56.7)
Treatment patterns and disease progression (physician-defined and proxy-reported) after eosinophilic oesophagitis diagnosis
Proton-pump inhibitors, n (%)	59 (61.5)	87 (87.9)	89 (91.8)	62 (66.7)
Swallowed topical corticosteroids (e.g., fluticasone budesonide), n (%) / Systemic (oral) corticosteroids, n (%)	79 (82.3) / 24 (25.0)	76 (76.8) / 7 (7.1)	55 (56.7) / 8 (8.3)	55 (59.1) / 4 (4.3)
Dietary modifications or eliminations, n (%)	53 (55.2)	41 (41.4)	46 (47.4)	41 (44.1)
Physician-defined disease progression, n (%)	12 (12.5)	6 (6.1)	7 (7.2)	15 (16.1)
Proxy-reported disease progression, n (%) / dilation performed, n (%)	26 (27.1) / 20 (20.8)	31 (31.3) / 16 (16.2)	34 (35.1) / 21 (21.7)	18 (19.4) / 10 (10.8)
Overall disease progression (Physician-defined OR Proxy-reported), n (%)	33 (34.4)	34 (34.3)	36 (37.1)	30 (32.3)

Conclusion

Adolescent and adult patients with EoE chronically experienced substantial disease burden. A subset demonstrated disease progression, perhaps underrecognised despite treatment with PPIs, STCs, and elimination diets. Hence, successful EoE management may include proactive disease monitoring, treating underlying pathophysiology and prescribing maintenance therapies to achieve long-term clinical remission.

References

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Disclosure

Ulrike von Arnim: Consulting and/or speaker fees from Dr. Falk Pharma, Sanofi, Astra Zeneca, EsoCap, Abbvie, Janssen, Takeda, Pfizer, Bristol Myers Squibb.
Frank Zerbib: Consulting and/or speaker fees from Sanofi, Dr Falk pharma, Bristol Myers Squibb, Bioprojet, AstraZeneca.
Tiffany Pela, Juby A. Jacob-Nara, Gaelle Le-Bagousse-Bego, Sarette T. Tilton: Employees of Sanofi; may hold stocks and/or stock options in the company.
Bram P. Raphael, Amr Radwan, Ryan B. Thomas: Employees of Regeneron Pharmaceuticals, Inc.; may hold stocks and/or stock options in the company.
Rohan C. Parikh, Fareedat Bello: Employees of RTI Health Solutions, which received research funding from Sanofi to design and execute this study.
Funding: This study was sponsored by Sanofi and Regeneron Pharmaceuticals, Inc.
Acknowledgement: Medical writing support was provided by Akshata Rao and Ali Nasir Siddiqui, PhD, of Sanofi.

Introduction

Esophageal food bolus obstruction (FBO) is a common presentation to Emergency Departments worldwide¹. There remains a paucity of data relating to efficacy of pre-endoscopic and endoscopic management resulting in a wide variety of clinical practice. Consensus guidelines do not advocate strongly for pre-endoscopic medications however they remain commonly used^2,3. This study evaluated the safety and efficacy of pre-endoscopic and endoscopic treatment in successful clearance of FBO and assessed the prevalence of underlying esophageal pathology.

Aims & Methods

ICD-10 codes retrospectively identified adult patients ≥18 years admitted to the Monash Health network (Melbourne, Australia) with esophageal FBO from 2010 to 2021. Medical records were reviewed to determine baseline characteristics, medical and endoscopic treatments and outcomes. Pre-endoscopic therapies included glucagon, glyceryl trinitrate (GTN), buscopan and Coca Cola. Multivariable analysis was performed to determine factors associated with pre-endoscopic clearance of FBO.

Results

608 patients were included. The median age was 56 years (IQR 39 – 71) and 405 (66.6%) were male. A prior history of FBO was noted in 228 (37.5%) patients, 110 (18.1%) had gastro-oesophageal reflux disease, 71 (11.7%) had dysphagia and 51 (8.4%) had a history of esophageal strictures. Inability to swallow saliva was noted in 296 (49.7%) patients at presentation.
Pre-endoscopic therapy was administered to 389 (64.0%) patients with a mean of 2 medications prescribed. Glucagon (47.4%), GTN (37.2%) and Coca Cola (36.3%) were most commonly administered. Successful FBO clearance was documented in 36.8% patients receiving medical therapy (glucagon 35.1%, GTN 36.2%, Coca Cola 38.0%); no individual medication significantly reduced the need for endoscopic intervention. Multi-variable analysis demonstrated that tolerating saliva (OR 1.95, p=0.025) and liquids (OR 2.28, p=0.001) significantly predicted spontaneous resolution of the EFBO without endoscopy.
474 (78.0%) patients proceeded to endoscopy. Median time to endoscopy was 14 hours (IQR 6 – 16) with 36.1% patients intubated for the procedure. The FBO was most commonly located in the lower esophagus (32.7%). The most common endoscopic findings were esophagitis (30.2%) and peptic ulcer disease (18.8%), with 3 (0.6%) malignancies identified. Endoscopic complications occurred in 35 (7.4%) patients (partial esophageal tear (n=24), aspiration pneumonia (n=5)). At endoscopy, a cause for the FBO was found in 130 (27.4%) patients, most commonly due to esophageal strictures (13.9%), eosinophilic esophagitis (11.2%) and Schatzki rings (9.1%). Esophageal biopsies were taken in 155 (32.7%) patients, of which 34.2% reached the diagnostic criteria for eosinophilic esophagitis.

Conclusion

Despite limited evidence, pre-endoscopic medical treatment of FBO is safe, commonly utilised, and results in spontaneous clearance in 36.8% patients. Patients’ clinical symptoms, in particular the ability to tolerate saliva or liquids, is the best predictor for spontaneous FBO clearance. Endoscopy remains highly effective and has a low complication rate.

References

1. Longstreth GF, Longstreth KJ, Yao JF. Esophageal food impaction: Epidemiology and therapy. A retrospective, observational study. Gastrointest Endosc. 2001;53(2):193-198. doi:10.1067/mge.2001.112709
2. Ikenberry SO, Jue TL, Anderson MA, et al. Management of ingested foreign bodies and food impactions. Gastrointest Endosc. 2011;73(6):1085-1091. doi:10.1016/j.gie.2010.11.010
3. Birk M, Bauerfeind P, Deprez P, et al. Removal of foreign bodies in the upper gastrointestinal tract in adults: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2016;48(05):489-496. doi:10.1055/s-0042-100456

Introduction

The impact of achieving endoscopic remission in ulcerative proctitis (UP) is unclear. The preferred long-term treatment goal in ulcerative colitis (UC) is achieving both the symptomatic resolution and endoscopic remission (ER),¹ which has been associated with reduced risk of complications, including colectomy.^2,3 UP is an anatomically limited form of UC, involving only the rectum. Unlike in extensive or left-sided UC, UP has not been associated with elevated colorectal cancer risk. Therefore, the achievement of endoscopic healing as compared to clinical remission in UP represents an uncertain therapeutic target.⁴

Aims & Methods

This study assessed the impact of achieving EH on subsequent outcomes in UP patients. This was a single-center retrospective cohort study including patients aged ≥ 18 with a confirmed diagnosis of UP based on clinical and endoscopic criteria. Included patients had at least two endoscopies and active endoscopic disease (Mayo endoscopy score [(MES) of 1, 2, or 3]) at the first (baseline) endoscopy. EH was defined as an MES of 0 or 1 at the second (follow-up) procedure. A minimum time of 1 month between scopes was required for inclusion. Descriptive statistics were used for baseline characteristics. The relationship of EH to IBD-related outcomes was assessed using univariate analysis (Pearson's Chi-squared test; Fisher's exact test; Welch Two Sample t-test) and we identified those independently associated with EH using multivariable logistic regression analysis (odds ratio with 95% confidence interval).

Results

Among 200 UP patients with baseline endoscopic activity, 109 patients (54.5%) achieved EH at follow-up. The median time from baseline to follow-up was 15 months (IQR: 6, 31). EH at follow-up was significantly associated with fewer IBD-related ED visits (healing: 8.3%, no healing: 21%) or hospitalizations (5.5% vs 18%) and fewer GI visits (mean: 8 [SD: 9], vs 17 [22]) after the second scope. Patients with EH were less likely to have iron deficiency anemia (IDA; 23% vs 41%), iron infusion (10% vs 25%), C. difficile infection (0.9% vs 6.6%), or to initiate a new biologic after relapse (15% vs 33%). Patients with EH also had a greater time to clinical relapse (650 days [730] vs 270 days [416]). In multivariable analysis, patients with mucosal healing had 68% lower odds of an IBD-related ED visit (OR: 0.32, 95% CI: 0.13, 0.73), 74% lower odds of IBD-related hospitalization (0.26 [0.09, 0.67]), and 64% lower odds of biologic initiation after relapse (0.36 [0.13, 0.95]) compared to patients with no mucosal healing, adjusting for the index MES score.

	Overall, N = 2001	Healing, N = 1091	No healing, N = 911	P-value2
IBD-Related ED Visit	28 (14%)	9 (8.3%)	19 (21%)	0.01
IBD-Related Hospitalization	22 (11%)	6 (5.5%)	16 (18%)	0.007
Total Number of GI Visits, mean (SD)	12 (17)	8 (9)	17 (22)	<0.001
IDA	62 (31%)	25 (23%)	37 (41%)	0.007
Iron Infusion	34 (17%)	11 (10%)	23 (25%)	0.004
C. Difficile Infection	7 (3.5%)	1 (0.9%)	6 (6.6%)	0.048
Biologic Initiation After Relapse (n=98)	24 (24%)	7 (15%)	17 (33%)	0.034

1 n (%)
2 Pearson's Chi-squared test; Welch Two Sample t-test; Fisher's exact test

Conclusion

UP patients with endoscopic healing had less IBD-related healthcare utilization (ED visits, hospitalizations, GI visits), fewer IBD-related complications (IDA, iron infusion, C. difficile infection), and were less likely to escalate to biologics after relapse. Our findings suggest that using a treatment target of endoscopic healing is desirable in UP and shed light on its potential utility in preventing disease-related complications and improving long-term outcomes.

References

1. Peyrin-Biroulet L, Sandborn W, Sands BE, et al. Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE): Determining Therapeutic Goals for Treat-to-Target. Off J Am Coll Gastroenterol ACG. 2015;110(9):1324-1338. doi:10.1038/ajg.2015.233
2. Colombel JF, Rutgeerts P, Reinisch W, et al. Early Mucosal Healing With Infliximab Is Associated With Improved Long-term Clinical Outcomes in Ulcerative Colitis. Gastroenterology. 2011;141(4):1194-1201. doi:10.1053/j.gastro.2011.06.054
3. Impact of mucosal healing on long‐term outcomes in ulcerative colitis treated with infliximab: a multicenter experience - Laharie - 2013 - Alimentary Pharmacology & Therapeutics - Wiley Online Library. Accessed September 24, 2022. https://onlinelibrary.wiley.com/doi/full/10.1111/apt.12289
4. Zhou Q, Shen ZF, Wu B sheng, et al. Risk of Colorectal Cancer in Ulcerative Colitis Patients: A Systematic Review and Meta-Analysis. Gastroenterol Res Pract. 2019;2019:1-11. doi:10.1155/2019/5363261

Disclosure

E.L., A.A.: no conflicts of interest to disclose
R.B.: Consulting/Speaker: Janssen, Abbvie, Bristol Myers Squibb, Prometheus Laboratories, Pfizer, Takeda
R.L.: Consulting/Speaking Fees: Pfizer, Enzymetrics, Ancilia Biosciences. Grant Support: National Institute of Health (NIH)
E.S.: Consulting/Speaking Fees: AbbVie, Crohn’s and Colitis Foundation of America (CCFA), Entera Health, Evidera, GI Health Foundation, Janssen, Protagonist Therapeutics, Seres Health, Takeda Pharmaceuticals, Bristol Myers Squibb. Grant Support: Abbott (AbbVie), AstraZeneca, CCFA, Janssen Research & Development, Johns Hopkins University, National Institute of Diabetes and Digestive and Kidney (NIDDK), National Institute of Health (NIH), New York Crohn’s Foundation, Pfizer, UCB, UCSF–CCFA Clinical Research Alliance, Genentech, Seres Therapeutics, Celgen. R.B.: Consulting: Prometheus
D.L.: Consulting/Speaking Fees: Abbvie, Boehringer Ingelheim, Eli Lilly, Fresenius Kabi, Janssen, Palatin, Pfizer, Prometheus Biosciences, Takeda; Grants: Abbvie, Janssen, Takeda

Introduction

With a growing interest in sex-specific differences in bowel preparation outcomes, current literature shows inconsistent results. Females have been associated with poor bowel preparation [1], while males may have inadequate bowel preparation due to poor compliance with instructions [2]. Analyses of randomized clinical trials of 1L polyethylene glycol (PEG) plus ascorbic acid (ASC) indicated greater high-quality (HQ) cleansing success in females than in males despite greater adenoma detection in males [3].

Aims & Methods

The effectiveness and tolerability of 1L PEG+ASC was compared in males versus females in a large real-world population. This post-hoc analysis of an observational, multi-centre, retrospective study in Spain and Portugal included patients who received 1L PEG+ASC before undergoing a colonoscopy [4]. Cleansing quality was assessed using the Boston Bowel Preparation Scale (BBPS). Adequate success was BBPS ≥6 with all segmental scores ≥2 and HQ success was BBPS ≥8 with BBPS 3 in the right colon. Polyp detection rate (PDR), adenoma detection rate (ADR) and adverse events (AEs) were also assessed. Results are reported either as mean ± SD. Chic-square test was used to compare outcomes.

Results

A total of 13,169 patients, (M/F: 6,406/6,763 aged 57.6 ± 12.7 / 56.4 ± 13.4 years) were included. The main indication for colonoscopy was (in males vs females) colorectal cancer screening: 42.5% vs 41.2%; diagnostic: 25.9% vs 32.7%; follow up: 28.6% vs 23.9%; or other: 2.9% vs 2.2%. Bowel preparations were taken either as an overnight split dose (males vs females: 32.3% vs 33.2%) or a same-day split dose (67.7% vs 66.8%). Males and females had similar (97.5% vs 97.1%) colonoscopy completion rates. Incomplete colonoscopies due to poor bowel preparation quality were rare and occurred at similar rates in males vs females (0.7% vs 0.9%).
In the overall colon, adequate success was similar in males vs females (89.5% vs 89.1%) (p = 0.40) while HQ success was more frequent in females vs males (54.1% vs 51.8%; p = 0.007). In the right colon segment, adequate success was similar in males vs females (91.4% vs 91.6%; p = 0.61), while HQ success was more frequent in females vs males (50.7% vs 47.8%; p < 0.001). The mean BBPS was similar overall and by segment (Table). As expected from the literature, the PDR and ADR were greater in males vs females in the overall colon and in the right colon (Table).

Table. Sex differences in bowel preparation parameters with 1L PEG + ASC

Variable	Males (n=6,406)	Females (n = 6,763)	P-value
Overall colon adequate success, n (%)	5,734 (89.5)	6,023 (89.1)	ns
Overall colon high-quality success, n (%)	3,317 (51.8)	3,660 (54.1)	0.007
Right colon adequate success, n (%)	5,853 (91.4)	6,196 (91.6)	ns
Right colon high-quality success, n (%)	3,063 (47.8)	3,429 (50.7)	0.0009
Overall colon total BBPS, mean ± SD Right colon BBPS, mean ± SD Transverse colon BBPS, mean ± SD Left colon BBPS, mean ± SD	7.3 ± 1.8 2.4 ± 0.7 2.5 ± 0.7 2.5 ± 0.7	7.3 ± 1.9 2.4 ± 0.7 2.5 ± 0.7 2.4 ± 0.7	ns
PDR overall colon, n (%)	3,552 (55.5)	2,926 (43.3)	<.0001
PDR right colon, n (%)	1,643 (25.7)	1,381 (20.4)	<.0001
ADR overall colon, n (%) na	2,200 (47.3) 4,654	1,753 (37.7) 4,656	<.0001
ADR right colon, n (%) na	1,139 (27.2) 4,193	915 (21.5) 4,264	<.0001

^aNumber of patients for whom histological information was available.

Males had fewer adverse events than females (1.8% vs 2.7%; p = 0.0008). While 98.2% males did not report any adverse events, those who did reported nausea (0.9%) or vomiting (0.6%). Similarly, 97.3% females did not report any adverse events, but those who did reported nausea (1.5%) or vomiting (1.0%).

Conclusion

In real-world clinical practice, 1L PEG + ASC was effective and well tolerated in both males and females. Females attained greater HQ cleansing success both overall and in the right colon.

References

References:

1. Cirocco WC et al. Dis Colon Rectum 1995; 38:964–968
2. Ness RM, et al. Am J Gastroenterol 2001; 96:1797–1802
3. Epstein M et al. Endosc Int Open 2021; 09: E1324–E1334
4. Esteban López-Jamar JM et al. UEG Journal 2022, Vol 10 (S8); OP022

Disclosure

Fatma Akriche and Carmen Turbi Disla are employees of Norgine Ltd

Introduction

Propofol administration managed directly by the gastroenterologist is a sedation regimen, which is broadly spreading, in clinical practice in Endoscopy Units (EU) all over the world [1]. This is primarily due to a very high patient and endoscopist satisfaction. Moreover, fears associated with propofol use by non-anesthesia providers are based on sound theoretical principles. Non-anesthesiologist-administered-propofol (NAAPS) managed by the gastroenterologist is an issue still controversial for many anesthesiologist societies.

Aims & Methods

This study aims to analyze safety outcomes between NAAPS sedation and anesthesiologist-assisted deep sedation during endoscopic procedures for low-risk patients. We retrospectively assessed data from low anesthesiologist risk-patients (American Society of Anesthesiologists I-II), undergone esophagogastroduodenoscopies (EGDs) and colonoscopies under NAAPS sedation, and assisted anesthesiologist-deep sedation, between May 2019 and October 2021, in a tertiary center. Primary outcome was to compare sedation related-adverse events rates between NAAPS and deep sedation. Propensity score matching analysis was performed using sex, age, Body Mass Index (BMI), smoking, comorbidities and time examination in order to standardize baseline variables.

Results

Overall, in colonoscopies subset, 2491 patients were managed under NAAPS and 257 patients under deep sedation, whereas in EGDs subset, 2439 patients were managed under NAAPS and 282 patients under deep sedation. In unmatched analysis, no difference was shown in terms of adverse events rates between NAAPS and deep sedation, both in EGDs and colonoscopies subsets (1.8% vs 3.5%; p=0.202 and 1 vs 0,4%, p=0.815, respectively). After matching, EGDs subset analysis comprised 282 procedures in NAAPS group versus 188 in deep sedation group, whereas colonoscopies subset included 256 patients in NAAPS group and 174 in deep sedation group. Matched analysis revealed non-different adverse events rate between moderate and deep sedation groups (colonoscopies 3.5% vs 0.6%, p=0.249 and EGD 0.4% vs 1%, p=0.452, respectively).

Conclusion

NAAPS during endoscopy represents a safe sedation modality, comparable with safety outcomes of anesthesiologist-assisted deep sedation. Cost-efficacy analyses are needed, in order to highlight economic advantages of non-anesthesiologist management of propofol during endoscopy.

References

[1] Gouda B, Gouda G, Borle A, Singh A, Sinha A, Singh PM. Safety of non-anesthesia provider administered propofol sedation in non-advanced gastrointestinal endoscopic procedures: A meta-analysis. Saudi J Gastroenterol. 2017;23(3):133-143. doi:10.4103/sjg.SJG_501_16

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.