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SCREENING FOR ADVANCED LIVER DISEASE IN THE DISEASE MANAGEMENT PROGRAM FOR TYPE 2 DIABETES

Maurice Michel 1, Michelle Doll 1, Nastasia Albert 1, Christian Labenz 1, Peter Robert Galle 1, Jörn Schattenberg 1

Affiliations

1 University Medical Centre Mainz, Mainz, Germany

Summary

AI Generated

A prospective cohort study of 175 patients with type 2 diabetes in German primary care found very high prevalence of liver disease, with 77% having steatosis, 42% fibrosis, and 12% cirrhosis by transient elastography.

Among participants in the German diabetes disease management program, 70% had NAFLD, with obesity strongly associated with both hepatic fibrosis (OR 4.82) and cirrhosis (OR 3.87) in multivariable analysis.
The study population had median age 66 years, median BMI 31.1 kg/m², and 59% were obese; median HbA1c was 7.0%.
Obese individuals showed the highest median liver stiffness values at 11.3 kPa; HbA1c correlated with fibrosis but was not an independent predictor.
The authors note that NAFLD is not currently included in routine screening within the German diabetes disease management program and suggest VCTE could enable risk stratification for intensified management.

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Abstract

Introduction

Type 2 diabetes mellitus (T2DM) is associated with end-organ injury and is a major risk factor for non-alcoholic fatty liver disease (NAFLD) and advanced liver disease. Despite the high relevance of NAFLD in T2DM, it remains unconsidered in the routine screening of T2DM-related comorbidities in the German diabetes disease management program (DMP).

Aims & Methods

The aim of this prospective cohort study was to assess the prevalence of liver disease from NAFLD and associated clinical risk factors in primary care centers participating in the diabetes DMP in Germany. A total of 175 participants with the diagnosis of T2DM were enrolled in two primary care outpatient centers within the diabetes DMP. The prevalence of steatosis, fibrosis, and cirrhosis was assessed non-invasively using vibration-controlled transient elastography (VCTE). Steatosis was defined as a controlled attenuation parameter (CAP) of ≥ 275 dB/m. Liver fibrosis and cirrhosis were defined as a liver stiffness measurement (LSM) of ≥ 8 kPa and ≥ 15 kPa, respectively. Multivariable logistic regression analysis with stepwise selection was performed to identify clinical predictors of liver fibrosis and cirrhosis.

Results

The majority of participants were male (62%, n = 109), and the median age was 66 years (IQR 59; 71). The median BMI was 31.1 kg/m² (IQR 27.7; 35.3), with 58.9% (n = 103) of the participants being obese. The median HbA1c was 7.0% (IQR 6.5; 7.8). The prevalence of hepatic steatosis, fibrosis, and cirrhosis was 77.1%, 42.3%, and 12%, respectively. NAFLD was identified in the majority of participants (69.9%; n = 121). Obese individuals showed the highest median LSM values (11.3 kPa, IQR 9.4; 16.2). In multivariable logistic regression analysis, obesity was associated with increased odds of hepatic fibrosis (OR = 4.818, 95% CI 2.243-10.350) and cirrhosis (OR = 3.873, 95% CI 1.073-13.977). Although higher blood levels of HbA1c correlated with liver fibrosis, it did not remain an independent predictor.

Conclusion

The prevalence of advanced liver disease is high within the diabetes DMP in Germany. People with T2DM and obesity are at an increased risk to exhibit liver fibrosis, and eventually cirrhosis. Building on VCTE for risk stratification within the DMP would allow identifying the subgroup recommended for intensified management.

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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ONE DAY OF ANTIBIOTIC TREATMENT IS NON-INFERIOR TO 4-7 DAYS IN PATIENTS WITH ACUTE CHOLANGITIS AFTER ADEQUATE BILIARY DRAINAGE: A MULTI-CENTRE RANDOMISED CONTROLLED TRIAL (COBRA)

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UEG Week 2026: Top abstract awards

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ONE DAY OF ANTIBIOTIC TREATMENT IS NON-INFERIOR TO 4-7 DAYS IN PATIENTS WITH ACUTE CHOLANGITIS AFTER ADEQUATE BILIARY DRAINAGE: A MULTI-CENTRE RANDOMISED CONTROLLED TRIAL (COBRA)

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ONE DAY OF ANTIBIOTIC TREATMENT IS NON-INFERIOR TO 4-7 DAYS IN PATIENTS WITH ACUTE CHOLANGITIS AFTER ADEQUATE BILIARY DRAINAGE: A MULTI-CENTRE RANDOMISED CONTROLLED TRIAL (COBRA)

Anouk Overdevest 1,2,3, Elske Sieswerda 4,5, Sylke Haal 1,2, Marcel G. W. Dijkgraaf 6, Karam Boparai 7, Frank ter Borg 8, Menno A. Brink 9, Foke van Delft 10, Vincent K. Dik 11, Lennard Gilissen 12, Muhammed Hadithi 13, Wouter Hazen 14, Frans Van Der Heide 15, Wouter J. den Hollander 16, Akin Inderson 17, Pieter Jan de Jonge 18, Sjoerd Kuiken 19, J. Marius Munneke 20, Bart Opsteeg 21, Lars Perk 22, Edgar J. G. Peters 23, Alexander C. Poen 24, Jan Werner Poley 25, Rutger Quispel 26, Wout Rohof 19, Robert Scheffer 27, Dirk Scholvinck 28, Ellert J. van Soest 29, Adriaan Tan 30, Willem J. Thijs 31, Niels G. Venneman 32, Robert C. Verdonk 33, Frank P. Vleggaar 34, Wim van de Vrie 35, Jan Maarten Vrolijk 36, Roy LJ van Wanrooij 23, Pim Weijenborg 37, Mattheus Carolus Benignus Wielenga 1, Roeland Zoutendijk 33, Johannes A. Bogaards 38, Jan M. Prins 1, Rogier P. Voermans 2,1,3

Affiliations

1 Amsterdam UMC, Location University of Amsterdam, Amsterdam, Netherlands

2 Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam, Netherlands

3 Cancer Centre Amsterdam, Amsterdam, Netherlands

4 European Clinical Research Alliance on Infectious Diseases (Ecraid), Utrecht, Netherlands

5 Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands

6 Amsterdam UMC, Location of University of Amsterdam, Amsterdam, Netherlands

7 Amstelland Ziekenhuis, Amstelveen, Netherlands

8 Deventer Hospital, Deventer, Netherlands

9 Meander Medical Centre, Bilthoven, Netherlands

10 Radboud University Medical Centre, Hilversum, Netherlands

11 Frisius Medical Centre, Leeuwarden, Netherlands

12 Catharina Ziekenhuis, Eindhoven, Netherlands

13 Maasstad Hospital, Rotterdam, Netherlands

14 Elisabeth TweeSteden Hospital, Tilburg, Netherlands

15 University Medical Center Groningen, Groningen, Netherlands

16 Alrijne Hospital, Leiderdorp, Netherlands

17 Leiden University Medical Center, Leiden, Netherlands

18 Erasmus MC, Rotterdam, Netherlands

19 OLVG, Amsterdam, Netherlands

20 Flevo Hospital, Almere, Netherlands

21 Groene Hart Ziekenhuis, Gouda, Netherlands

22 Haaglanden Medical Centre, The Hague, Netherlands

23 Amsterdam UMC, Location Vrije Universiteit Amsterdam, Amsterdam, Netherlands

24 Isala Clinics, Zwolle, Netherlands

25 Maastricht University Medical Centre, Maastricht, Netherlands

26 Reinier de Graaf Gasthuis, Delft, Netherlands

27 Jeroen Bosch Hospital, S´Hertogenbosch, Netherlands

28 Zaans Medical Centre, Zaandam, Netherlands

29 Spaarne Hospital, Hoofddorp, Netherlands

30 Canisius Wilhelmina Hospital, Nijmegen, Netherlands

31 Martiniziekenhuis, Groningen, Netherlands

32 Medisch Spectrum Twente, Enschede, Netherlands

33 St. Antonius Ziekenhuis, Nieuwegein, Netherlands

34 University Medical Centre Utrecht, Utrecht, Netherlands

35 Albert Schweitzer Hospital, Dordrecht, Netherlands

36 Rijnstate Hospital, Arnhem, Netherlands

37 Dijklander Hospital, Hoorn, Netherlands

38 Amsterdam UMC, Location Vrije Universiteit, Amsterdam, Netherlands

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Abstract

Introduction

International guidelines recommend 4-7 days of antibiotic treatment after adequate biliary drainage for acute cholangitis [1]. Observational data suggest shorter treatment may be sufficient [2].

Aims & Methods

We assessed whether 1 day of antibiotic treatment is non-inferior to 4-7 days of antibiotic treatment after adequate endoscopic biliary drainage in adults with acute cholangitis. This multicentre, open-label, randomised controlled non-inferiority trial was conducted across 31 hospitals in the Netherlands. We enrolled adults with acute cholangitis (according to Tokyo Guidelines 2018 criteria) due to distal biliary obstruction who achieved adequate endoscopic biliary drainage and fever resolution within 24 hours after ERCP. Patients were randomly assigned 1:1 to receive antibiotics for 1 or 4-7 day(s) after ERCP, stratified by blood culture status and cholangitis aetiology (benign or malignant obstruction) at the time of randomisation. We excluded patients with concomitant infections or receiving immunosuppressive therapy.
The primary outcome was clinical cure, defined as the patient being symptom-free by day 14, without relapse or death occurring by day 30. Secondary outcomes included (all-cause) mortality, and antibiotic-related adverse events. The total follow-up period was 90 days. Key outcomes, including clinical cure and cholangitis-related mortality, were adjudicated by an independent blinded committee. Analyses followed intention-to-treat at ≥90% protocol adherence, otherwise per-protocol. In our primary analysis, we concluded non-inferiority if the one-sided 95% confidence limit for the absolute risk difference in clinical cure exceeded -7.5%. Additionally, we performed exploratory subgroup analyses for the stratification factors.

Results

Between 2023 and 2025, we randomized 413 patients (1-day group: n = 205; 4-7-day group: n = 208). Three patients (all in the 4-7-day group) were lost to follow-up before the primary outcome could be assessed and were excluded from all analyses. Median age was 74 years, 43.4% were women, 10.0% had malignant obstruction, 57.6% had moderate/severe cholangitis, and 35.6% had gram-negative bacteraemia at the time of randomisation. Adherence to the allocated antibiotic treatment duration was 93.0%.
In the intention-to-treat analysis, clinical cure occurred in 195/205 patients (95.1%) in the 1-day group versus 192/205 (93.7%) in the 4-7-day group, with an absolute risk difference of 1.5% (one-sided 95% confidence limit: -2.4%), demonstrating non-inferiority (table 1). All-cause 90-day mortality was 6/205 (2.9%) in the 1-day group versus 3/205 (1.5%) in the 4-7-day group; cholangitis-related mortality was 2/205 (1.0%) versus 0/205 (0%). Antibiotic-related adverse events were reported in 8.3% in the 1-day group vs. 16.6% in the 4-7-day group. Non-inferiority for clinical cure was maintained in the prespecified subgroup analyses for malignant obstruction and gram-negative bacteraemia.

Analysis population	1-day (short-course) (clinical cure / total, %)	4-7 days (longer course) (clinical cure / total, %)	Absolute risk difference (%)	One-sided 95% confidence limit (%)
Primary analysis Intention-to-treat (n = 410)	195/205 (95.1)	192 / 205 (93.7)	1.5	-2.4
Subgroup analysis - aetiology of acute cholangitis, at randomisation Malignant obstruction All other aetiologies	19/20 (95.0) 176 / 185 (95.1)	18 / 21 (85.7) 174 / 184 (94.6)	9.3 0.6	-5.6 -3.2
Subgroup analysis - blood culture results, at randomisation Gram-negative bacteraemia Other positive blood culture, negative or unknown	67 / 72 (93.1) 128 / 133 (96.2)	67 / 74 (90.5) 125 / 131 (95.4)	2.5 0.8	-4.9 -3.2

Conclusion

One day of antibiotic treatment after adequate endoscopic biliary drainage is non-inferior to 4-7 days in adults with acute cholangitis, with more antibiotic-related adverse events in the 4-7-day group. Therefore, 1 day should be the preferred duration of antibiotic treatment after adequate biliary drainage.

References

[1] Gomi H, Solomkin JS, Schlossberg D, Okamoto K, Takada T, Strasberg SM, et al. Tokyo Guidelines 2018: antimicrobial therapy for acute cholangitis and cholecystitis. J Hepatobiliary Pancreat Sci. 2018;25(1):3–16.
[2] Haal S, Ten Böhmer B, Balkema S, Depla AC, Fockens P, Jansen JM, et al. Antimicrobial therapy of 3 days or less is sufficient after successful ERCP for acute cholangitis. United Eur Gastroenterol J. 2020;8(4):481–8.

Disclosure

Nothing to dislose.

Event

UEG Week Barcelona 2026

Topics

Endoscopy Mechanisms & Personalised Medicine Digestive Oncology Hepatobiliary

Submission format

Abstract

Session

Opening plenary

Citation

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

Published

2026

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ONE DAY OF ANTIBIOTIC TREATMENT IS NON-INFERIOR TO 4-7 DAYS IN PATIENTS WITH ACUTE CHOLANGITIS AFTER ADEQUATE BILIARY DRAINAGE: A MULTI-CENTRE RANDOMISED CONTROLLED TRIAL (COBRA)

Rogier P. Voermans

UEG Week 2026: Top abstract awards

THE PEPPER TRIAL: WHAT TO EXPECT WHEN STOPPING CHRONIC PROTON PUMP INHIBITOR THERAPY IN PRIMARY CARE PATIENTS

Florencia Carbone

DEFINING THE OPTIMAL STRATEGY FOR PROTON PUMP INHIBITOR DEPRESCRIBING: RESULTS FROM THE PEPPER TRIAL

Florencia Carbone

UNDERWATER VERSUS CONVENTIONAL ENDOSCOPIC SUBMUCOSAL DISSECTION FOR COLORECTAL NEOPLASIA: A MULTICENTER, RANDOMISED CONTROLLED TRIAL

Francesco Di Matteo

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Roos E. Pouw

UEG Presentation

New

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

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UEG Week 2026: Top abstract awards

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Abstract

Event

UEG Week Barcelona 2026

Topics

Endoscopy Mechanisms & Personalised Medicine Digestive Oncology

Session

Opening plenary

Citation

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

Published

2026

More Like This:

ONE DAY OF ANTIBIOTIC TREATMENT IS NON-INFERIOR TO 4-7 DAYS IN PATIENTS WITH ACUTE CHOLANGITIS AFTER ADEQUATE BILIARY DRAINAGE: A MULTI-CENTRE RANDOMISED CONTROLLED TRIAL (COBRA)

Rogier P. Voermans

UEG Week 2026: Top abstract awards

THE PEPPER TRIAL: WHAT TO EXPECT WHEN STOPPING CHRONIC PROTON PUMP INHIBITOR THERAPY IN PRIMARY CARE PATIENTS

Florencia Carbone

DEFINING THE OPTIMAL STRATEGY FOR PROTON PUMP INHIBITOR DEPRESCRIBING: RESULTS FROM THE PEPPER TRIAL

Florencia Carbone

UNDERWATER VERSUS CONVENTIONAL ENDOSCOPIC SUBMUCOSAL DISSECTION FOR COLORECTAL NEOPLASIA: A MULTICENTER, RANDOMISED CONTROLLED TRIAL

Francesco Di Matteo

From squamous to Barrett’s: Endoscopic treatment of oesophageal neoplasia

Roos E. Pouw

UEG Presentation

New

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

THE PEPPER TRIAL: WHAT TO EXPECT WHEN STOPPING CHRONIC PROTON PUMP INHIBITOR THERAPY IN PRIMARY CARE PATIENTS

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THE PEPPER TRIAL: WHAT TO EXPECT WHEN STOPPING CHRONIC PROTON PUMP INHIBITOR THERAPY IN PRIMARY CARE PATIENTS

Janne Scheepers 1, Karen Van den Houte 1, Annouschka Laenen 1, Jan Tack 2, Florencia Carbone 1

Affiliations

1 KU Leuven, Leuven, Belgium

2 University of Leuven, University Hospital Gasthuisberg, Leuven, Belgium

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Abstract

Introduction

Inappropriate long‑term use of proton pump inhibitors (PPIs) is common, with up to 82% of chronic prescriptions lacking a valid indication. Treatment is rarely tapered or discontinued once initiated. A key barrier to deprescribing is the (re-)occurrence of gastrointestinal symptoms, which often leads to treatment resumption. Moreover, insight into the long‑term evolution of individual symptoms following PPI discontinuation is lacking.

Aims & Methods

This study aimed to characterize the expected evolution of gastrointestinal symptoms during and after PPI deprescribing in primary care. In this pragmatic clinical trial, 61 general practitioners recruited and randomised patients to one of three PPI deprescribing strategies. After following the assigned strategy for 1 month, patients were requested to stop PPI use and were followed up for 1 year. Gastrointestinal symptom severity (PAGI-SYM) and quality of life (PAGI-QOL) were assessed at all timepoints. Antacids were allowed as rescue therapy throughout the trial. Successful patients were defined as limited those with PPI use (<4 doses per month) and willingness to continue their current treatment, from follow-up onward. Linear mixed models were used. Random effects were modelled to deal with the longitudinal data structure. The fixed effect model included time, group and time by group interactions. Analyses were performed on an ITT basis. Results are presented as mean±SD or median (IQR).

Results

627 patients were randomized (60±14 years old, BMI 28±5kg/m², 60% female, median PPI use 9 (5-15) years). Following initiation of the deprescribing strategies, a transient increase in upper gastrointestinal symptoms was observed after one month of deprescribing. Compared to baseline, overall symptom severity increased significantly (p<0.0001), driven by worsening heartburn, nausea, postprandial fullness, early satiation, and upper abdominal pain (all p<0.0001). This increase was driven mainly by the increased symptom severity in unsuccessful patients, as the overall symptom severity did not increase in the successful patients. Notably, bloating severity decreased significantly from the month of deprescribing onward (p<0.0001) and continued to decline, resulting in lower bloating scores throughout the entire follow‑up period compared with baseline. During the follow-up period, overall PAGI‑SYM scores improved to below baseline levels (p<0.0001). Postprandial fullness and early satiation improved significantly from 3 months follow-up onward (p=0.0005), accompanied by improvement in lower abdominal pain (p=0.0060). Upper abdominal pain decreased significantly from 6 months follow-up onward (p=0.0047). No significant differences in symptom pattern are seen based on the initial PPI indication. Quality of life improved from the follow-up period onward (p<0.0001).

Conclusion

PPI deprescribing in long‑term users is associated with a short‑term transient increase in upper gastrointestinal symptoms, followed by progressive and sustained symptom improvement over time. Quality of life and multiple symptom domains improve beyond baseline at follow‑up. These findings confirm the feasibility of PPI deprescribing and provide relevant insights for patient counselling and expectation management during deprescribing phases.

Event

UEG Week Barcelona 2026

Topics

Stomach & H. Pylori Oesophagus

Submission format

Abstract

Session

Anti-secretory therapy: Evolving standards and future horizons

Citation

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

Published

2026

More Like This:

ONE DAY OF ANTIBIOTIC TREATMENT IS NON-INFERIOR TO 4-7 DAYS IN PATIENTS WITH ACUTE CHOLANGITIS AFTER ADEQUATE BILIARY DRAINAGE: A MULTI-CENTRE RANDOMISED CONTROLLED TRIAL (COBRA)

Rogier P. Voermans

UEG Week 2026: Top abstract awards

THE PEPPER TRIAL: WHAT TO EXPECT WHEN STOPPING CHRONIC PROTON PUMP INHIBITOR THERAPY IN PRIMARY CARE PATIENTS

Florencia Carbone

DEFINING THE OPTIMAL STRATEGY FOR PROTON PUMP INHIBITOR DEPRESCRIBING: RESULTS FROM THE PEPPER TRIAL

Florencia Carbone

UNDERWATER VERSUS CONVENTIONAL ENDOSCOPIC SUBMUCOSAL DISSECTION FOR COLORECTAL NEOPLASIA: A MULTICENTER, RANDOMISED CONTROLLED TRIAL

Francesco Di Matteo

From squamous to Barrett’s: Endoscopic treatment of oesophageal neoplasia

Roos E. Pouw

UEG Presentation

New

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

DEFINING THE OPTIMAL STRATEGY FOR PROTON PUMP INHIBITOR DEPRESCRIBING: RESULTS FROM THE PEPPER TRIAL

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DEFINING THE OPTIMAL STRATEGY FOR PROTON PUMP INHIBITOR DEPRESCRIBING: RESULTS FROM THE PEPPER TRIAL

Janne Scheepers 1, Karen Van den Houte 1, Annouschka Laenen 1, Jan Tack 2, Florencia Carbone 2

Affiliations

1 KU Leuven, Leuven, Belgium

2 University of Leuven, University Hospital Gasthuisberg, Leuven, Belgium

Summary

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Abstract

Introduction

Inappropriate proton pump inhibitor (PPI) use is a growing concern, with up to 82% of long-term PPI use lacking a valid indication. Current guidelines recommend prolonged PPI therapy for severe esophagitis, Barrett’s oesophagus, Zollinger–Ellison syndrome, or ulcer prevention in high-risk patients. However, PPIs are often not tapered or discontinued.

Aims & Methods

The PEPPER trial aims to identify the most effective strategy for discontinuing chronic PPI therapy in primary care patients without an indication for long-term use. In this pragmatic clinical trial, 61 general practitioners recruited and randomised patients to one of three PPI deprescribing strategies: (A) on-demand PPI use, (B) replacement of PPI by alginate QID, and (C) intermittent PPI use following a fixed schedule. Absence of an H2-blocker in our clinical setting excluded this PPI deprescribing option. Patients receiving high-dose PPI therapy at baseline were required to down-titrate to a maintenance dose over one month prior to randomization. After following the assigned strategy for 1 month, patients were requested to stop PPI/alginate use and were followed up for 1 year. Gastrointestinal symptom severity (PAGI-SYM) and quality of life (PAGI-QOL) were assessed at all timepoints. Antacids were allowed as rescue therapy throughout the trial. The primary endpoint was the proportion of patients achieving a successful therapeutic outcome (STO), defined as limited PPI use (<4 doses per month) and willingness to continue their current treatment. STO rates were assessed across the three strategies, and potential predictors of success were evaluated using Log-binomial regression analysis. Analyses were performed on an intention-to-treat basis. Results are presented as mean±SD or median (IQR), as appropriate.

Results

A total of 629 patients were randomized (60±14 years old, BMI 28±5kg/m², 60% female, median PPI use 9 (5-15) years). Of the 122 patients initially treated with high-dose PPIs, 91% successfully down-titrated to a maintenance dose. After one year, prolonged STO was achieved by 43.2% of patients overall (n=236/546). Success rates were comparable across deprescribing strategies: 46.8% with on-demand PPI use (strategy A), 42.8% with alginate substitution (strategy B), and 39.4% with intermittent PPI use (strategy C). Failure to achieve STO was associated with elevated baseline symptoms of heartburn (RR=0.818(0.727;0.922), p=0.0010), postprandial distress (RR=0.842(0.760;0.933), p=0.0010), epigastric pain (RR=0.887(0.881;0.970), p=0.0083); and reduced symptom-related quality of life (RR=0.769(0.667;0.886), p=0.0003).

Conclusion

This analysis shows that PPI dose-reduction is feasible in primary care, with 92% of patients able to lower their PPI dose and 43% of patients achieving successful prolonged deprescription. Deprescription via on-demand PPI use, an intermittent scheme, and replacement with an alginate all had similar success rates in stopping unnecessary PPI use. Lower baseline symptom burden and better symptom-related quality of life are key predictors of success, underscoring the importance of careful symptom assessment and patient-centered support during PPI deprescribing.

Event

UEG Week Barcelona 2026

Topics

Stomach & H. Pylori Oesophagus

Submission format

Abstract

Session

Anti-secretory therapy: Evolving standards and future horizons

Citation

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

Published

2026

More Like This:

ONE DAY OF ANTIBIOTIC TREATMENT IS NON-INFERIOR TO 4-7 DAYS IN PATIENTS WITH ACUTE CHOLANGITIS AFTER ADEQUATE BILIARY DRAINAGE: A MULTI-CENTRE RANDOMISED CONTROLLED TRIAL (COBRA)

Rogier P. Voermans

UEG Week 2026: Top abstract awards

THE PEPPER TRIAL: WHAT TO EXPECT WHEN STOPPING CHRONIC PROTON PUMP INHIBITOR THERAPY IN PRIMARY CARE PATIENTS

Florencia Carbone

DEFINING THE OPTIMAL STRATEGY FOR PROTON PUMP INHIBITOR DEPRESCRIBING: RESULTS FROM THE PEPPER TRIAL

Florencia Carbone

UNDERWATER VERSUS CONVENTIONAL ENDOSCOPIC SUBMUCOSAL DISSECTION FOR COLORECTAL NEOPLASIA: A MULTICENTER, RANDOMISED CONTROLLED TRIAL

Francesco Di Matteo

From squamous to Barrett’s: Endoscopic treatment of oesophageal neoplasia

Roos E. Pouw

UEG Presentation

New

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

UNDERWATER VERSUS CONVENTIONAL ENDOSCOPIC SUBMUCOSAL DISSECTION FOR COLORECTAL NEOPLASIA: A MULTICENTER, RANDOMISED CONTROLLED TRIAL

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UNDERWATER VERSUS CONVENTIONAL ENDOSCOPIC SUBMUCOSAL DISSECTION FOR COLORECTAL NEOPLASIA: A MULTICENTER, RANDOMISED CONTROLLED TRIAL

Gianluca Andrisani 1, Giulio Antonelli 2, Sandro Sferrazza 3, Federico Barbaro 4, Silvia Pecere 4, Francesco Pugliese 5, Mattia Corradi 6, Luigi Giovanni Papparella 7, Cesare Hassan 8, Mattia Brigida 9, Giulio Calabrese 3, Arianna Andreozzi 10, Antonio Facciorusso 11, Guido Costamagna 12, Michele Cicala 13, Francesco Di Matteo 14

Affiliations

1 Campus Biomedico Roma, Rome, Italy

2 Gastroenterology and Digestive Endoscopy Unit, Ospedale dei Castelli (N.O.C.), Roma, Italy

3 Gastroenterology and Endoscopy Unit, ARNAS Civico Hospital, Palermo, Italy

4 Digestive Endoscopy Unit, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università Cattolica del Sacro Cuore di Roma, Center for Endoscopic Research Therapeutics and Training, Roma, Italy

5 ASST NIGUARDA, Milano, Italy

6 Digestive Endoscopy Unit, ASST Niguarda, Milan, Italy

7 Digestive Endoscopy, Ospedale Isola Tiberina - Gemelli Isola, Rome, Italy

8 Endoscopy Unit, Humanitas Clinical and Research Center IRCCS, Pieve Emanuele MI, Italy

9 Department of Experimental Medicine, Università del Salento, Palermo, Italy

10 Digestive Endoscopy Unit, University Campus Bio-Medico, Rome, Italy

11 Department of Experimental Medicine, Università del Salento, Lecce, Italy

12 Digestive Endoscopy, Ospedale Isola Tiberina - Gemelli Isola, Roma, Italy

13 Università Campus Bio Medico, Roma, Italy

14 Digestive Endoscopy Unit, University Campus Bio-Medico, Roma, Italy

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Abstract

Introduction

Underwater endoscopic submucosal dissection (UESD) has been proposed as a technical modification of conventional gas-assisted ESD (GESD) to improve operative field stability and procedural efficiency during colorectal ESD. However, comparative evidence remains limited, particularly in Western practice.

Aims & Methods

We conducted a prospective, multicentre, open-label, randomised controlled trial across five Italian tertiary referral centres between December 2024 and December 2025. Adult patients referred for colorectal ESD were randomly assigned 1:1 to UESD or GESD. The trial was designed as a non-inferiority study for en bloc resection with a prespecified margin of 10%. Secondary endpoints included R0 resection, procedural time, dissection speed, smoke interference, intraprocedural bleeding, use of hemostatic forceps, and post-procedural adverse events.

Results

Overall, 295 patients were randomised and 286 completed the assigned procedure (143 per arm). En-bloc resection was achieved in 142/143 lesions (99.3%) in both groups, with an absolute risk difference of 0.0% (95% CI −3.2-3.2), supporting non-inferiority of UESD. R0 resection rates were similar (95.1% vs 95.8%). Compared with GESD, UESD was associated with shorter procedural time (median 59.0 vs 70.0 min), faster dissection speed (27.0 vs 21.4 mm²/min), less smoke interference (8.4% vs 48.3%), less intraprocedural bleeding (19.6% vs 35.0%), and lower use of hemostatic forceps (44.8% vs 61.5%). Adjusted analyses confirmed these findings.

Conclusion

In this first multicentre randomised trial of UESD, and the first European randomised comparison of underwater versus gas-assisted colorectal ESD, UESD was non-inferior to GESD for en bloc resection while improving key procedural outcomes.

References

Pimentel-Nunes P, Libânio D, Bastiaansen BAJ, Bhandari P, Bisschops R, Bourke MJ, et al. Endoscopic submucosal dissection for superficial gastrointestinal lesions: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2022. Endoscopy. 2022;54(6):591–622. doi:10.1055/a-1811-7025.
Tanaka S, Kashida H, Saito Y, Yahagi N, Yamano H, Saito S, et al. JGES guidelines for colorectal endoscopic submucosal dissection/endoscopic mucosal resection. Dig Endosc. 2015;27:417–434. doi: 10.1111/den.12456.
Fuccio L, Hassan C, Ponchon T, Mandolesi D, Farioli A, Cucchetti A, et al. Clinical outcomes after endoscopic submucosal dissection for colorectal neoplasia: a systematic review and meta-analysis. Gastrointest Endosc. 2017;86:74–86.e17. doi: 10.1016/j.gie.2017.02.024.
Singh RR , Nanavati J, Gopakumar H, Kumta NA. Colorectal endoscopic submucosal dissection in the West: A systematic review and meta-analysis. Endosc Int Open. 2023 Nov 27;11(11):E1082-E1091. doi: 10.1055/a-2181-5929.
Matsumoto A, Tanaka S, Oba S, Kanao H, Oka S, Yoshihara M, et al. Outcome of endoscopic submucosal dissection for colorectal tumors accompanied by fibrosis. Scand J Gastroenterol. 2010;45:1329–1337. doi: 10.3109/00365521.2010.495416.

Disclosure

The authors have no conflict of interest related to the manuscript.

Event

UEG Week Barcelona 2026

Topics

Digestive Oncology Endoscopy Colorectal

Submission format

Abstract

Session

Endoscopic resection: Cut, cure, prevent

Citation

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

Published

2026

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From squamous to Barrett’s: Endoscopic treatment of oesophageal neoplasia

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From squamous to Barrett’s: Endoscopic treatment of oesophageal neoplasia

Roos E. Pouw 1

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1 Amsterdam UMC, Amsterdam, Netherlands

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Abstract

Event

Postgraduate Teaching Programme Barcelona 2026

Topics

Oesophagus Endoscopy Digestive Oncology

Session

Scope it out: Endoscopic mastery in upper GI neoplasia

Citation

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

Published

2026

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