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REMIMAZOLAM VERSUS PROPOFOL FOR SEDATION IN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY: A NON-INFERIORITY STUDY

Jungnam Lee 1, Jin-Seok Park 2

Affiliations

1 Inha University College of Medicine, Incheon, Korea, Republic of

2 Inha university School of Medicine, Incheon, Korea, Republic of

Summary

AI Generated

A randomized single-blind trial comparing remimazolam and propofol for ERCP sedation demonstrated non-inferiority of remimazolam with comparable safety but slower onset and recovery times.

The primary endpoint of successful ERCP completion without rescue medication was achieved in 100% of patients in both remimazolam (n=53) and propofol (n=55) groups
The incidence and frequency of treatment-emergent adverse events including desaturation were comparable between the two groups
Propofol showed significantly faster ERCP initiation time (mean 63.18 ± 16.56 seconds) compared to remimazolam (75.23 ± 32.27 seconds; p=0.02)
Time to full alertness after ERCP was significantly shorter with propofol (304.18 ± 146.25 seconds) versus remimazolam (448.34 ± 224.09 seconds; p<0.001)
The study concludes that remimazolam can be considered a safe and effective alternative to propofol for ERCP sedation

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Abstract

Introduction

Endoscopic retrograde cholangiopancreatography (ERCP) is a frequently employed procedure for diagnosing and treating pancreaticobiliary diseases. The selection of an appropriate sedative agent is crucial for ensuring patient comfort and procedural success. An optimal sedative should offer a predictable duration of action and a high safety profile. This study aimed to compare the efficacy and safety of remimazolam and propofol in patients undergoing ERCP procedures.

Aims & Methods

A randomized, single-blind, single center study was conducted comparing remimazolam and propofol for inpatient ERCP sedation. The study medications were administered under the supervision of the endoscopist. A total of 110 patients scheduled for ERCP were randomly assigned to receive either remimazolam or propofol. The primary endpoint was a composite of successful procedure completion and no requirement for rescue medication. Secondary endpoints included sedation efficacy, recovery time, and adverse events.

Results

Of the 110 patients randomized, 108 underwent sedation and ERCP (53 received remimazolam, 55 propofol). The primary endpoint was achieved for 100% of patients in both groups. The incidence and frequency of treatment-emergent adverse events, including desaturation, were comparable between the two groups. ERCP initiation occurred sooner in the propofol group (mean, 63.18 ± 16.56 seconds) compared to the remimazolam group (75.23 ± 32.27 seconds; p-value=0.02). Additionally, the time to full alertness after ERCP completion was significantly shorter in the propofol group than the remimazolam group (304.18 ± 146.25 vs. 448.34 ± 224.09 seconds; p-value<0.001).

Conclusion

This trial demonstrated non-inferiority of remimazolam to propofol in achieving the primary endpoint of successful ERCP completion without the need for rescue medication. The incidence and frequency of adverse events were comparable between the two groups. However, our study also revealed that propofol had a faster onset and recovery time compared to remimazolam. Although this difference may not be clinically significant, it could have practical implications in certain cases. Consequently, remimazolam can be considered a safe and effective alternative to propofol for ERCP sedation, potentially expanding clinicians’ options and improving patient outcomes. Further research is warranted to determine the optimal choice of sedative agents for various patient populations and procedures.

Conference

UEG Week Copenhagen 2023

Topics

Hepatobiliary

Submission format

Abstract

Session

PP 07 Liver & biliary (Posters)

Citation

United European Gastroenterology Journal 2023; 11 (Supplement 8)

Published

2023

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UEG Online Courses x UEG Podcast: Oesophageal Cancer

Roos E. Pouw, Ana-Maria Bucalau

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Abstract

Topics

Digestive Oncology Oesophagus

Published

2026

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Pedro Narra Figueiredo

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SPRAY COAGULATION REDUCES INTRAPROCEDURAL BLEEDING DURING ENDOSCOPIC SUBMUCOSAL DISSECTION COMPARED TO SWIFT COAGULATION: A PROPENSITY SCORE–MATCHED COHORT STUDY

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SPRAY COAGULATION REDUCES INTRAPROCEDURAL BLEEDING DURING ENDOSCOPIC SUBMUCOSAL DISSECTION COMPARED TO SWIFT COAGULATION: A PROPENSITY SCORE–MATCHED COHORT STUDY

Andrea Sorge 1,2, Michele Montori 2, Maria Eva Argenziano 2, Tamás Tornai 3, Adam Monod 2, Pieter Jan Poortmans 4, Lobke Desomer 5, David James Tate 6

Affiliations

1 University of Padua, Padua, Italy

2 University Hospital Ghent, Ghent, Belgium

3 Semmelweis University, Budapest, Hungary

4 University Hospital Ghent, University Hospital Brussels, Asse, Belgium

5 Az Delta, Drongen, Belgium

6 University Hospital Ghent, Gent, Belgium

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Abstract

Introduction

Intraprocedural bleeding is a source of technical complexity during endoscopic submucosal dissection (ESD) and may require exchange to coagulation forceps. Spray coagulation is a non-contact, high–peak–voltage mode that combines tissue dissection with powerful coagulation. However, evidence supporting its use in ESD is limited to the stomach.

Aims & Methods

We aimed to evaluate whether spray-coagulation ESD (SP-ESD) improves intraprocedural bleeding control compared to swift ESD (SW-ESD). We analyzed consecutive esophageal, gastric, colonic, and rectal ESDs performed at a tertiary referral center over thirty-six months. SP-ESD was compared to SW-ESD. Assessment of complete procedural video was performed with event-level timestamps. SW-ESD procedures were matched 1:2 to SP-ESD procedures by propensity score on prespecified baseline covariates. The primary outcome was intraprocedural bleeding events. Secondary outcomes were total bleeding time, dissection speed, and coagulation forceps use.

Results

Of 147 eligible ESDs, 91 (60 SP-ESD, 31 SW-ESD) were matched. SP-ESD was associated with fewer bleeding events (mean 1.8 vs 4.2 per procedure; count ratio, .43; 95% CI, .26-.70; P = .001), persisting after accounting for dissection time (rate ratio, .51 per minute; 95% CI, .31-.85). Bleeding time was shorter (median .4 vs 5.5 minutes; ratio of means, .40; 95% CI, .22-.73) and dissection faster (median 16.8 vs 11.6 mm²/min; geometric mean ratio, 1.33; 95% CI, 1.03-1.70). Coagulation forceps were applied a mean of .1 versus 2.6 times per procedure, and 95.0% versus 29.0% were forceps-free (RR, 3.27; 95% CI, 1.79-5.99). R0 resection, en bloc resection, perforation, and delayed bleeding did not differ.

TABLE. Primary and secondary outcomes in the propensity score–matched cohort (n = 91)

Outcome	SW-ESD	SP-ESD	Effect (SP-ESD vs SW-ESD, 95% CI)	P value
Intraprocedural bleeds, mean (primary)	4.2	1.8	CR, .43 (.26-.70)	.001
Bleeding time, min, median	5.5	.4	Ratio of means, .40 (.22-.73)	.003
Dissection speed, mm2/min, median	11.6	16.8	GMR, 1.33 (1.03-1.70)	.027

Conclusion

SP-ESD was associated with substantially less intraprocedural bleeding and coagulation forceps use, and faster dissection without cost in resection quality or safety compared to SW-ESD. Spray coagulation mode can be selected as one of the available electrosurgical modalities to improve bleeding control during ESD.

Event

UEG Week Barcelona 2026

Topics

Primary Care Oesophagus Hepatobiliary Endoscopy Digestive Oncology Colorectal

Submission format

Late-Breaking Abstract

Session

Late-Breaking: Advances in GI-endoscopy

Citation

2026: United European Gastroenterology Journal 2026; 14 (S1)

Published

2026

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Pedro Narra Figueiredo

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Panel discussion: Pancreatic and small bowel neuroendocrine tumours

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Panel discussion: Pancreatic and small bowel neuroendocrine tumours

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Abstract

Event

Postgraduate Teaching Programme Barcelona 2026

Topics

Small Intestine & Nutrition Pancreas Digestive Oncology

Session

Pancreatic and small bowel neuroendocrine tumours

Citation

2026: United European Gastroenterology Journal 2026; 14 (S1)

Published

2026

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Best of UEG Week 2024 with Iris Dotan on IBD

Iris Dotan, Pradeep Mundre

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Abstract

Topics

IBD

Published

2024

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Pedro Narra Figueiredo

UEG Presentation

New

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Indications, contraindications and management of liver transplantation in acute liver failure

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Indications, contraindications and management of liver transplantation in acute liver failure

Annalisa Berzigotti 1

Affiliations

1 Inselspital, University Hospital of Berne, Berne, Switzerland

Summary

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Abstract

Event

Postgraduate Teaching Programme Barcelona 2026

Topics

Surgery Hepatobiliary

Session

Decision-making in acute liver failure: From expectant management to emergency transplant

Citation

2026: United European Gastroenterology Journal 2026; 14 (S1)

Published

2026

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Pedro Narra Figueiredo

UEG Presentation

New

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LONG-TERM GUT MICROBIOTA CHANGES DETERMINED BY QUADRUPLE THERAPY REGIMENS IN PATIENTS WITH HELICOBACTER PYLORI INFECTION IN A SOUTH-EUROPEAN COUNTRY: A 16S RRNA GENE SEQUENCING AND HIGH-THROUGHPUT SEQUENCING STUDY

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LONG-TERM GUT MICROBIOTA CHANGES DETERMINED BY QUADRUPLE THERAPY REGIMENS IN PATIENTS WITH HELICOBACTER PYLORI INFECTION IN A SOUTH-EUROPEAN COUNTRY: A 16S RRNA GENE SEQUENCING AND HIGH-THROUGHPUT SEQUENCING STUDY

Elisa Gravito-Soares 1,2, Nuno Peres Almeida 1,2, Marta Gravito-Soares 1,2, Barbara Rocha 3,4, Maria Manuela Donato 1,2, Pedro Narra Figueiredo 1,2

Affiliations

1 Hospitais da Universidade de Coimbra, Unidade Local de Saúde de Coimbra, Coimbra, Portugal

2 Faculty of Medicine, University of Coimbra, Coimbra, Portugal

3 Center for Neuroscience and Celular Biology, University of Coimbra, Coimbra, Portugal

4 Faculty of Pharmacy, University of Coimbra, Coimbra, Portugal

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Abstract

Introduction

Helicobacter pylori (H. pylori) infection remains a major public health problem. Given the high antibiotic resistance worldwide, quadruple regimens have emerged as first-line therapies for H. pylori infection, though their long-term consequences remain unclear.

Aims & Methods

Aim: To evaluate if quadruple therapies determine gut microbiota changes after H. pylori eradication.
Methods: All patients were submitted to H. pylori eradication with five quadruple therapies (A: Concomitant with metronidazole tid, 14-days; B: Concomitant with metronidazole bid, 14-days; C: Bismuth-containing Quadruple, 10-days; D: Sequential, 14-days; E: Hybrid, 14-days) in a blind, randomized trial. Esomeprazole was the proton-pump inhibitor of choice. Efficacy and safety rates after 2- and 12-months post-treatment were evaluated. Safety included gut microbiota analysis performed by sequencing bacterial 16S-rRNA genes (V1-3 region) of fecal samples by Illumina-MiSeq, including taxonomic composition (OTUs), alpha(Shannon)-diversity and beta-diversity (Bray-Curtis distances, PERMANOVA-adonis2 community diferences and MaAsLin3 differential abundance).

Results

A total of 233 patients (52.8%males; mean age: 57.6±16.2years) completed the protocol (A:46, B:47, C:47, D:47, E:46). Overall efficacy and adverse events rates were 97.9% and 53.6%, respectively. Regarding taxonomic composition for all regimens, Bacteroidota (42.1%; Bacteroides-25.3%, Prevotella_9-11.5%) was the most frequent, followed by Firmicutes (23.9%; Faecalibacterium-11.5%), with a Firmicutes-Bacteroidota Ratio (F-BR) of 0.57. Comparing the different regimens, there was a significant increase in Firmicutes and F-BR for regimen D and regimen E (D:χ²-10.00;p=0.017/χ²-12.00;p=0.004; E:χ²-12.00;p=0.004/χ²-10.00;p=0.017). Concerning alpha-diversity, regimen D showed significant enrichment relative to regimen B (B-D:χ²-0.38;p=0.048), 2-months post-treatment. Regarding beta-diversity, regimen D showed a significant increase compared to other regimens (A-D:r2(1,2.13)=0.023;p=0.003; B-D:r2(1,2.49)=0.026;p=0.002; C-D:r2(1,2.88)=0.030;p=0.001). Two-months post-treatment, by-genus-taxonomic diversity was significant for Firmicutes, namely a decrease of Flavonifractor (A-D:-1.95;p<0.003; B-D:-2.32;p<0.001; C-D:-1.97;p=0.003), UCG-003/UCG-005 (A-D:-1.84;p<0.001/ B-D:-2.63;p=0.005) and Subdoligranulum (B-D:-1.96;p=0.022), and an increase of Oscillibacter (A-D:1.55;p=0.021) and UC5-1-2E3 (A-E:3.33;p<0.001; B-D:2.86;p<0.001); Actinobacteriota, with Bifidobacterium (A-D:1.94;p=0.004) increasing; and Bacteroidota, with Prevotellaceae (A-D:-4.25;p<0.001) decreasing. Twelve-months post-treatment, by-genus-taxonomic diversity was significant for Firmicutes, with Lachnoclostridium (A-D:1.29;p<0.001) and Oscillibacter (A-D:1.42;p<0.001) increasing. An increase of Lachnospiraceae_UCG-004 in Firmicutes diversity denotes a microbiota signature for successful eradication.

Conclusion

Quadruple therapies are highly effective in eradicating H. pylori, although associated with long-term adverse events, including gut microbiota changes. Gut dysbiosis was significant for regimens D and E, with an increase in Firmicutes and F-BR. In long-term post-eradication, microbiota diversity showed a significant change in Firmicutes, with an increase of Lachnoclostridium and Oscillibacter. Lachnospiraceae_UCG-004 increasing embodies a microbiota signature for successful eradication. These findings highlight the potential of microbiota profiling in risk stratification and need for microbiota-modifying strategies alongside the currently standard treatment for H. pylori eradication.

References

Zamani M, et al. Systematic review with meta-analysis: the worldwide prevalence of Helicobacter pylori infection. Aliment Pharmacol Ther 2018;47(7):868-876.
Malfertheiner P, et al. Management of Helicobacter pylori infection – the Maastricht V/Florence Consensus Report. Gut 2017;66(1):6-30.
Savoldi A, et al. Prevalence of antibiotic resistance in Helicobacter pylori: a systematic review and meta-analysis in World Health Organization Regions. Gastroenterology 2018;155(5):1372-1382.
Lopo I, et al. Helicobacter pylori antibiotic resistance in Portugal: Systematic review and metaanalysis. Helicobacter 2018;23(4):e12493.
Albush A, et al. The impact of Helicobacter pylori infection and eradication therapies on gut microbiota: a systematic review of microbial dysbiosis and its implications in gastric carcinogenesis. Front Cell Infect Microbiol 2025;15:1592977.
Sitkin S, et al. Gastrointestinal microbiome and Helicobacter pylori: Eradicate, leave it as it is, or take a personalized benefit-risk approach? World J Gastroenterol 2022;28(7):766-774.
Du L, et al. Effects of Helicobacter pylori Therapy on Gut Microbiota: A Systematic Review and Meta-Analysis. Dig Dis 2024;42(1):102-112.
Ye Q, et al. Changes in the human gut microbiota composition caused by Helicobacter pylori eradication therapy: A systematic review and meta-analysis. Helicobacter 2020;25(4):e12713.

Disclosure

None of the authors have anything to declare with regard to personal or financial interests in carrying out this work.

Event

UEG Week Barcelona 2026

Topics

Gut Microbiota Stomach & H. Pylori Mechanisms & Personalised Medicine Digestive Oncology Oesophagus

Submission format

Abstract

Session

H. pylori: At the nexus of molecular mechanisms and clinical care

Citation

2026: United European Gastroenterology Journal 2026; 14 (S1)

Published

2026

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Pedro Narra Figueiredo