Clinical Case Summary

Closure of mucosal defects after endoscopic submucosal dissection (ESD) may reduce the risk of postprocedural perforation and bleeding. However, defect closure with traditional through-the-scope (TTS) or over-the-scope (OTS) clips and OTS suturing devices may be technically limited by defect size and location. The development of a new through-the-scope helix tack suture system (TTSS) has emerged as a promising tool for overcoming these limitations, particularly when combined with TTS clips.

We present two cases of gastric ESD defect closure with TTSS and adjunctive TTS clip application, highlighting the outcomes and main challenges to achieve complete defect closure.

CASE 1: 73-year-old woman with a 15mm Paris 0-IIb dysplastic lesion of the posterior wall of the antrum. En-bloc ESD was performed and the 25mm mucosal defect was closed with TTSS in a ‘Z’ pattern. However, suboptimal tack placement resulted in incomplete closure of the central portion of the scar, leaving two areas of exposed submucosa at the edges. Complete defect closure was accomplished with the additional placement of four TTS clips at the edges, only possible due to the previously achieved proximity.

CASE 2: 55-year-old man referred for ESD of a 13mm Paris 0-IIa dysplastic lesion in the lesser curvature of the antrum. En-bloc ESD was accomplished, and the resulting 25mm mucosal defect was closed using TTSS in a 'Z' pattern. Complete defect closure was achieved with the additional placement of one TTS clip.

Both patients were discharged the following day and presented with no complications at 1-month follow-up.

These cases highlight the potential of TTSS becoming a practical solution for the closure of complex post-ESD defects, allowing earlier patient discharge. While this novel TTSS with adjunctive TTS clip application appears to be effective in the management of sizable defects, proper suture pattern and tack placement are paramount for achieving complete defect closure.

References

1. Kobara H, Tada N, Fujihara S, Nishiyama N, Masaki T. Clinical and technical outcomes of endoscopic closure of postendoscopic submucosal dissection defects: Literature review over one decade. Dig Endosc. 2023 Jan;35(2):216-231.
2. Hernandez-Lara A, Garcia Garcia de Paredes A, Rajan E, Storm AC. Step-by-step instruction: using an endoscopic tack and suture device for gastrointestinal defect closure. VideoGIE. 2021;6(6):243-245.
3. Hernandez A, Marya NB, Sawas T, Rajan E, Gades NM, Wong Kee Song LM, et al. Gastrointestinal defect closure using a novel through-the-scope helix tack and suture device compared to endoscopic clips in a survival porcine model (with video). Endosc Int Open. 2021 Apr;9(4):E572-E577.
4. Canakis A, Dawod SM, Dawod E, Simons M, Di Cocco B, Westerveld DR, et al. Efficacy, Feasibility, and Safety of the X-Tack Endoscopic HeliX Tacking System: A Multicenter Experience. J Clin Gastroenterol. 2024 Jan 29.
5. Canakis A, Deliwala SS, Frohlinger M, Twery B, Canakis JP, Shaik MR, et al. Endoscopic outcomes using a novel through-the-scope tack and suture system for gastrointestinal defect closure: a systematic review and meta-analysis. Endoscopy. Published online March 22, 2024.

Clinical Case Summary

A 67-year-old man initially presented in 2020 with intermittent dysphagia for solid food. An endoscopy of the upper gastrointestinal tract revealed an inflammatory, presumed peptic stenosis at the level of the Z-line. No hiatus hernia was present. A balloon dilatation was performed and therapy with proton pump inhibitors was started. This maintained remission until 2023, when he represented with frequent bolus retention, retrosternal chest pain and regurgitation. A repeat endoscopy appeared normal; however, biopsies revealed lymphocytic esophagitis. A high-resolution oesophageal manometry was performed to clarify the cause of dysphagia. Water swallows showed no abnormal findings; however, the patient had repeated, symptomatic outlet-obstruction during the solid test meal. This finding is often seen in eosinophilic esophagitis.¹ The diagnosis of primary lymphocytic esophagitis, considered to be a variant of this condition,² was proposed. Treatment with oro-dispersible budesonide (1mg bid) was started.
At the same time, an abnormal AV conduction pattern was noted on ECG. Echocardiography and a cardiac stress test were normal; however, CT imaging showed bihilar lymphadenopathy with peri-lymphatic pulmonary nodules. Broncho-alveolar lavage showed lymphocytic alveolitis (29% lymphocytes) and an elevated CD4/CD8 ratio (ratio = 4). ACE (51 U/l) was normal and granulomas were not seen on fine needle aspiration of the lymph nodes; however, the diagnosis of stage 2 pulmonary sarcoidosis was confirmed on PET-CT. Oral prednisolone (30mg od) replaced locally active steroids. The patient was symptom free after one month treatment.
Sarcoidosis is a granulomatous disease that often affects the lungs, skin and lymph nodes; however, involvement of the digestive tract is rare, and secondary lymphocytic esophagitis has hardly ever been described.³ The investigation, primary or secondary aetiology, and management of dysphagia in this case of lymphocytic esophagitis will be discussed.

References

1. Sykes C, Fairlamb G, Fox M, et al. Assessment of Esophageal Motility in Patients With Eosinophilic Esophagitis: A Scoping Review. J Clin Gastroenterol 2023;57:10-30.
2. Greuter T, Straumann A, Fernandez-Marrero Y, et al. Characterization of eosinophilic esophagitis variants by clinical, histological, and molecular analyses: A cross-sectional multi-center study. Allergy 2022;77:2520-2533.
3. Brito-Zeron P, Bari K, Baughman RP, et al. Sarcoidosis Involving the Gastrointestinal Tract: Diagnostic and Therapeutic Management. Am J Gastroenterol 2019;114:1238-1247.

Disclosure

None of the authors have any conflict of interest to disclose

Introduction

Functional gastrointestinal disorders (FGIDs) are more prevalent in female than in male patients [1,2]. This triggers the question whether this is also reflected in medical care, especially also in self-medication, where often botanicals are used. A potential source of data to address this question is the PhytoVIS study, a pharmacoepidemiological study conducted in Germany in more than 20,000 patients taking herbal medicinal products.

Aims & Methods

To have a large and homogenous data base for a gender-related evaluation, records for a clinically proven herbal medicinal product (HMP) often used in FGIDs, STW 5 [3,4], were evaluated to uncover potential gender-related differences in the pharmacotherapy of FGIDs.

Results

1513 records were evaluated, 71 % of them from females and 29 % from males, i.e. a 4 % higher proportion of females compared to the overall population of the PhytoVIS study. Main criterium for the evaluation was the Clinical Global Impression Scale – Efficacy (CGI-E). No major differences between females and males were found, apart that women perceived a minimally better effect of the therapy. The reported symptoms were differentiated into symptoms associated with functional dyspepsia (FD), irritable bowel syndrome (IBS), or symptoms that can be associated with both. As far as the records allow a differentiation, no gender differences could be observed. This applies also to the perceived efficacy, the tolerability and the onset of action.

Conclusion

So, while there are differences in the prevalence of FGIDs in women and men, there are no therapeutically relevant pharmacoepidemiological differences in patients with functional gastrointestinal diseases treated with a medicinal product indicated in these diseases, so suggesting that there is no gender gap in this highly relevant therapeutic field.

References

1. Kim YS, Kim N. Sex-Gender Differences in Irritable Bowel Syndrome. J Neurogastroenterol Motil. 2018;24:544-558
2. Houghton LA, Heitkemper M, Crowell M, Emmanuel A, Halpert A, McRoberts JA, Toner B. Age, Gender and Women's Health and the Patient. Gastroenterology. 2016; S0016-5085(16)00183-9;
3. Malfertheiner P. STW 5 (Iberogast) Therapy in Gastrointestinal Functional Disorders. Dig Dis. 2017;35 Suppl 1:25-29
4. Madisch A, Vinson BR, Abdel-Aziz H, Kelber O, Nieber K, Kraft K, Storr M. Modulation of gastrointestinal motility beyond metoclopramide and domperidone : Pharmacological and clinical evidence for phytotherapy in functional gastrointestinal disorders. Wien Med Wochenschr. 2017;167:160-168

Disclosure

JW and EC were interns, OK, is employee of Steigerwald Arzneimittelwerk GmbH, Darmstadt, Germany, KN und KK have received fees from the same company.

Introduction

Dietary and lifestyle recommendations are the cornerstones of the treatment of GERD. However, the evidence of the efficacy of those recommendations is lacking. We performed a retrospective analysis of the GISTAR study¹ participants evaluating the symptoms of GERD and dietary and lifestyle parameters developing a tool for predicting GERD symptoms based on the aforementioned criteria.

Aims & Methods

The aim of the study was to analyse the factors pointing to GERD symptoms through the use of data mining and decision tree classifier.
Methods: GERD diagnosis was evaluated using a self-assessment questionnaire ². Dietary, demographic and lifestyle data were collected within the GISTAR study protocol¹. 3340 40-64 year old participants from the GISTAR study were included in the analysis. 1670 of them did not have GERD symptoms. 41 attributes describing demographic, lifestyle, and dietary habits were used for these respondents to induce a decision tree classification model using Orange Data Mining software³.

Results

Fried potatoes including French fries were the most predictive factor of GERD symptoms (65.3% with symptoms; 1516 from 2321), especially for females (82.6%; 1048/1228). This was more pronounced in the group who consumed sweets once per week (87.2%, 950/1090). In males, who consumed fried potatoes, the next most important factor was the consumption of sweets (46.3%, 431/930).
For participants who didn’t consume fried potatoes (14.6%; 147/1008), 1-3 cups of green tea (37.9%; 66/174) and male gender (71.4 % 20/28) were predictors of GERD symptoms.
The accuracy of the decision tree model was: sensitivity (74.8%), precision (75.6%), specificity (75.9%) and AUC (0.841%).

Conclusion

Fried potatoes, female gender and consumption of sweets are the risk factors predicting the diagnosis of GERD. None of the lifestyle factors were displayed as significant.

References

1. Leja M, Park JY, Murillo R, et al. Multicentric randomised study of Helicobacter pylori eradication and pepsinogen testing for prevention of gastric cancer mortality: the GISTAR study. BMJ Open 2017;7:e016999. doi: 10.1136/bmjopen-2017-016999
2. Jones R, Junghard O, Dent J, Vakil N, Halling K, Wernersson B, Lind T. Development of the GerdQ, a tool for the diagnosis and management of gastro-oesophageal reflux disease in primary care. Aliment Pharmacol Ther. 2009 Nov 15;30(10):1030-8. doi: 10.1111/j.1365-2036.2009.04142.x. Epub 2009 Sep 8. PMID: 19737151.
3. Demsar J, Curk T, Erjavec A, Gorup C, Hocevar T, Milutinovic M, Mozina M, Polajnar M, Toplak M, Staric A, Stajdohar M, Umek L, Zagar L, Zbontar J, Zitnik M, Zupan B (2013) Orange: Data Mining Toolbox in Python, Journal of Machine Learning Research 14(Aug): 2349−2353.

Introduction

Vonoprazan (VPZ)-based regimens are an effective first-line therapy for Helicobacter pylori infection. However, their value as a rescue therapy needs to be explored.

Aims & Methods

We assessed a VPZ-based regimen as a H. pylori rescue therapy.
Patients with a history of H. pylori treatment failure were administered 20 mg VPZ twice daily, 750 mg amoxicillin 3 times daily, and 250 mg Saccharomyces boulardii twice daily for 14 days. ¹³C-urea breath tests were used to assess H. pylori status; adverse events were recorded using a questionnaire.

Results

We enrolled 68 patients with 1–3 previous eradication failures. The overall eradication rates calculated using intention-to-treat and per-protocol analyses were 92.6% (63/68) and 92.3% (60/65), respectively. The eradication rate did not differ with the number of treatment failures. The rates of clarithromycin, metronidazole, and levofloxacin resistance were 91.3% (21/23), 100% (23/23), and 60.9% (14/23), respectively. In 60.9% (14/23) patients, the H. pylori isolate was resistant to all 3 antibiotics. The eradication rate was higher among patients without anxiety (96.8%) than among patients with anxiety (60.0%, P = 0.025). No severe adverse events occurred; 95.6% (65/68) patients showed good compliance. Serological examination showed no significant changes in liver and kidney function.

Conclusion

Vonoprazan and amoxicillin dual regimen with S. boulardii supplementation is a safe and effective H. pylori rescue therapy, with an acceptable eradication rate (>90%), regardless of the number of prior treatment failures. Anxiety was associated with eradication failure, and the regimen may need to be adjusted for patients with anxiety.

Introduction

SBS-IF is a severe organ failure condition with life-long PS dependence. Glucagon-like peptide-2 (GLP-2) stimulates intestinal adaptation resulting in increased absorptive capacity of nutrients and fluids. Apraglutide (APRA) is a novel long-acting synthetic GLP-2 analog in development for SBS-IF.

Aims & Methods

We performed a pre-defined interim analysis of a phase 2 study in SBS-IF-CiC to investigate the safety and efficacy of 4W APRA treatment based on metabolic balance studies (MBS). STARS Nutrition is a 52W phase 2 study in adult patients with SBS-IF-CiC receiving once-weekly subcutaneous APRA injections. Metabolic balance studies were performed at baseline and 4w with stable PS, followed by a 48w PS adjustment period. During MBS, fluid intake was kept constant (individual predefined drinking menu). Duplicates of meals and fluids (wet weight intake), urine and feces (fecal wet weight output) were collected. Safety was the primary endpoint. Secondary endpoints included changes in fecal wet weight output, urinary output, wet weight and energy absorption. Data are presented as mean (95% CI). P-values <0.05 were considered significant (Wilcoxon matched-pairs signed rank test).

Results

Nine patients were included and comprise the full study population. APRA was well tolerated (no dose discontinuation or interruption). Fecal wet weight output decreased significantly by 253 (-437 – -68) g/day (p=0.012). Relative wet weight absorption increased by 9 (1 – 18) % (p=0.039). There was a numeric increase in urinary output (p=0.129). No significant changes in energy absorption were observed.

Conclusion

These initial short-term results of APRA in SBS-IF-CiC support safety and efficacy in increasing relative but not absolute wet weight absorption. One-year treatment outcomes are awaited to assess the full effect on wet weight, energy, and macronutrient absorption.

Disclosure

FJ has received grants/research support/honoraria or consultation fees from Baxter, Fresenius Kabi, Nestlé Health Sciences, BBraun, Theradial, Mayoli, Biocodex, mobile 3econsulting, NPS Pharmaceuticals, Shire, Takeda, Therachon, VectivBio and Zealand Pharma.
PBJ has received grants/research support/honoraria or consultation fees from Albumedix A/S, ArTara Therapeutics, Bainan Biotech, Baxter, Coloplast, Ferring, Fresenius Kabi, GLyPharma, Naia Pharma, NPS Pharmaceuticals, Shire, Takeda, The Novo Nordisk Foundation, Therachon, VectivBio and Zealand Pharma.
TV has served on the speaker bureau for Fresenius Kabi, Remedus, Takeda, and VectivBio. TV has provided clinical advice to Baxter, Shire, Takeda, VectivBio, Zealand Pharma. TV has received research grants from Takeda and VectivBio.
This research was supported by VectivBio. FB, CL and OK are employees of VectivBio.