Introduction

Malignant distal biliary obstruction is a common complication in the progression of pancreatic tumors. Endoscopic ultrasound (EUS) guided drainage can provide effective biliary drainage when not achieved by endoscopic retrograde cholangiopancreatography (ERCP) and can be performed by hepaticogastrostomy or choledocoduodenostomy (CDD). Gallbladder drainage by cholecystogastrostomy (GBD) has been described in small uncontrolled series and could be effective. The objective of this study was to compare the clinical efficacy of CGD vs CDD in distal biliary tract obstruction (DBTO).

Aims & Methods

This was a retrospective, multicenter study (four tertiary centers) including all consecutive patients with DBTO and jaundice who underwent CDD or GBD with a lumen-apposing metal stent (LAMS). The primary outcome was to compare the clinical success rate defined as a decrease of total bilirubin by 50% in 14 days and/or a decrease in total bilirubin below 51 µmol/L after 30 days. Secondary outcomes were technical success, overall survival, survival without biliary reintervention, immediate (within 24 hours) and delayed (>24 hours) morbidity.

Results

78 patients were included between July 2018 and September 2022, 41 GBD and 37 CDD. The mean age was 71 years, and 82% had pancreatic adenocarcinoma, 55% had metastatic disease at diagnosis, and 45% had duodenal stenosis. Most patients (N=59; 76%) had undergone EUS-guided drainage after ERCP failure. The mean diameter of the main bile duct was significantly smaller in the CGD group (13 mm vs. 18 mm; p=0.001). The total bilirubin mean was 196 µmol/L in the GBD group vs. 241 µmol/L in the CDD group; p=0.149. Clinical success was comparable between the two groups: 88% (36/41 - CGD) vs. 89.2% (33/37 - CDD); p=0.848. There was no difference in overall survival (log-rank p=0.727) or survival without biliary obstruction (log-rank p=0.725) between the two groups. Immediate morbidity was comparable: 7% (3/41 - GBD) vs. 13% (5/37 - CDD); p=0.368. The rate of significant immediate complications tended to be lower in the GBD group (5% (2/41 - CGD) vs. 8% (3/37 - CDD); p=0.093). Delayed morbidity (mainly LAMS obstruction) (>24 hours) was lower in the GBD group 7.3% (3/41 - CGD) vs. 27% (10/37 - CDD); p=0.022. There were no biliary complications after the 26th day in the GBD group. The LAMS dimensions did not have an impact on biliary complications in the CGD group (6x8mm vs. 10x10mm vs. 15x10mm).

Conclusion

Biliary drainage of tumoral obstruction of the distal biliary tract by GBD had comparable clinical efficacy and was associated with reduced delayed morbidity compared to CDD. This type of drainage is feasible, especially when the main bile duct is not dilated enough to consider CDD.

References

Maire F, Hammel P, Ponsot P, Aubert A, O’Toole D, Hentic O, et al. Long-term outcome of biliary and duodenal stents in palliative treatment of patients with unresectable adenocarcinoma of the head of pancreas. Am J Gastroenterol. 2006 Apr;101(4):735–42.
van der Merwe SW, van Wanrooij RLJ, Bronswijk M, Everett S, Lakhtakia S, Rimbas M, et al. Therapeutic endoscopic ultrasound: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2022 Feb;54(2):185–205.
Issa D, Irani S, Law R, Shah S, Bhalla S, Mahadev S, et al. Endoscopic ultrasound-guided gallbladder drainage as a rescue therapy for unresectable malignant biliary obstruction: a multicenter experience. Endoscopy. 2021 Aug;53(8):827–31.

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.

Introduction

Recent societal guidelines suggest there is no role for hydrogen and methane breath testing (HMBT) to exclude small intestinal bacterial overgrowth (SIBO) in patients with diarrhoea predominant irritable bowel syndrome (IBS) and to treat symptoms with rifaximin empirically^1,2. However, a positive result for SIBO with lactulose HMBT has been shown to predict more favourable outcomes to rifaximin in patients with diarrhoea predominant IBS³. We wanted to investigate if symptoms and medical history can predict lactulose HMBT outcome hence justifying treatment of SIBO without a formal diagnosis.

Aims & Methods

A large questionnaire-based study was conducted in over 1000 patients of which 731 completed lactulose HMBT. The 26-item questionnaire included questions about medical history, symptoms, and pattern of symptoms, and we used this to identify any positive predictors for SIBO on HMBT. A positive lactulose HMBT was determined by a rise of ≥20 ppm in breath hydrogen from baseline within 90 minutes³. Breath samples were analysed using gas chromatography. Associations and predictors were calculated using chi square tests and logistic regression, respectively.

Results

Bloating (93.6%), abdominal pain (87.3%), and diarrhoea (80.3%) were the most common symptoms reported by those with a positive result for SIBO, but their duration, frequency and onset were no different to patients with a negative result (P > 0.05). There were no positive predictors for SIBO on lactulose HMBT based on symptoms, medications or medical history except for chronic low ferritin (P = 0.025).

Conclusion

This large questionnaire study has demonstrated that symptoms and medical history cannot predict HMBT outcomes for SIBO. Therefore, treatment of SIBO without a diagnosis confirmed on HMBT may lead to unnecessary antibiotic use and costs.

References

1. Vasant DH, Paine PA, Black CJ, Houghton LA, Everitt HA, Corsetti M, Agrawal A, Aziz I, Farmer AD, Eugenicos MP, Moss-Morris R, Yiannakou Y, Ford AC. British Society of Gastroenterology guidelines on the management of irritable bowel syndrome. Gut. 2021 Jul;70(7):1214-1240.
2. Savarino E, Zingone F, Barberio B, Marasco G, Akyuz F, Akpinar H, Barboi O, Bodini G, Bor S, Chiarioni G, Cristian G, Corsetti M, Di Sabatino A, Dimitriu AM, Drug V, Dumitrascu DL, Ford AC, Hauser G, Nakov R, Patel N, Pohl D, Sfarti C, Serra J, Simrén M, Suciu A, Tack J, Toruner M, Walters J, Cremon C, Barbara G. Functional bowel disorders with diarrhoea: Clinical guidelines of the United European Gastroenterology and European Society for Neurogastroenterology and Motility. United European Gastroenterol J. 2022 Jul;10(6):556-584.
3. Rezaie A, Heimanson Z, McCallum R, Pimentel M. Lactulose Breath Testing as a Predictor of Response to Rifaximin in Patients With Irritable Bowel Syndrome With Diarrhea. Am J Gastroenterol. 2019 Dec;114(12):1886-1893.

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.