Daniel Schmitz

Unresectable malignant distal biliary obstruction (MDBO) may be treated with endoscopic ultrasound-guided (EUS-BD) or percutaneous transhepatic (PTBD) biliary drainage if endoscopic retrograde cholangiopancreatography fails or is not feasible. This study compared EUS-BD and PTBD using an improved ultrasound-guided method with primary metal stenting. A prospective, longitudinal (follow-up 6 months), nonrandomized, noninferiority (10% margin) trial was conducted. Patients were assigned to centers with high competence in one of the two techniques. The primary end point was technical success, with propensity score matching employed to balance differences. Differences in secondary end points were evaluated with two-sided superiority analyses. 209 patients (mean age 73 years) were enrolled between December 2018 and August 2024 from 14 European centers and were subsequently matched 1:1. Noninferiority of PTBD vs. EUS-BD could not be demonstrated with regard to technical success (91.2% vs. 97.1%; P = 0.17; 95%CI –2.3% to 15.1%). Clinical success (intention-to-treat: 73.5% vs. 55.9%; P = 0.05), procedure time, length of hospital stay, and rate of biliary reintervention within 30 days (0.03 vs. 0.31; P < 0.001) were significantly better in the EUS-BD cohort, driven mainly by EUS-guided choledochoduodenostomy (EUS-CDS). No significant differences were observed in adverse events (grades 1–4) (16.7% vs. 14.5%; P = 0.82), pain score, clinical success (per-protocol), rate of biliary reinterventions within 6 months, or overall survival. EUS-BD, particularly EU-CDS, might be preferred over PTBD in unresectable MDBO owing to better clinical success and a lower biliary reintervention rate.

Most cystic lesions of the pancreas are nowadays identified as incidental findings on cross-sectional imaging (1). Some of these cysts are mucin-producing neoplasms, such as intraductal papillary mucinous neoplasms (IPMNs) and mucinous cystic...

Background: A dilated main pancreatic duct (MPD) ≥ 5 mm can be observed in main-duct IPMNs (MD-IPMN) and chronic pancreatitis (CP); however, distinguishing between the two differently treated diseases can be difficult. Cell-free (cf) DNA in MPD fluid obtained by EUS-guided FNA might help to distinguish MD-IPMN from CP. Methods: All patients with a dilated MPD ≥ 5 mm on EUS during the period of 1 June 2017 to 30 April 2024 were prospectively analysed in this single-centre study, with EUS-guided MPD fluid aspiration performed for suspected MD-IPMN or CP in patients who were suitable for surgery. Twenty-two known gastrointestinal cancer genes, including GNAS and KRAS, were analysed by deep targeted (dt) NGS. The results were correlated with resected tissue, biopsy, and long-term follow-up. Results: A total of 164 patients with a dilated MPD were identified, of which 30 (18.3%) underwent EUS-guided FNA, with 1 patient having a minor complication (3.3%). Twenty-two patients (mean MPD diameter of 12.4 (7–31) mm) with a definitive, mostly surgically confirmed diagnosis were included in the analysis. Only a fish-mouth papilla, which was present in 3 of 12 (25%) MD-IPMNs, could reliably differentiate between the two diseases, with history, symptoms, diffuse or segmental MPD dilation, presence of calcifications on imaging, cytology, and CEA in the ductal fluid failing to achieve differentiation. However, GNAS mutations were found exclusively in 11 of the 12 (91.6%) patients with MD-IPMN (p < 0.01), whereas KRAS mutations were identified in both diseases. Conclusions: GNAS testing by dtNGS in aspirated fluid from dilated MPD obtained by EUS-guided FNA may help differentiate MD-IPMN from CP for surgical resection.

Dysphagia is a common symptom in patients presenting to the gastroenterologist. However, extraluminal causes of dysphagia may be missed by endoluminal diagnosis alone. This case report presents a 72-year-old man with slowly progressive dysphagia that occurred with the ingestion of certain solid foods and was intermittently associated with severe aspiration. Esophagogastroduodenoscopy and barium swallow study were both normal. However, a conventional x-ray and computed tomography (CT) scan of the neck revealed diffuse idiopathic skeletal hyperostosis (Forestier's disease) of the anterior cervical spine (C2–C7). Fiber endoscopic evaluation of swallowing (FEES) revealed functionally incomplete emptying of the oral cavity during swallowing, and the patient reported dysphagia score (EAT-10) was 23 (normal < 3). Surgical removal of the hyperostosis (C3–C6) resulted in immediate and sustained improvement in dysphagia at 3 months.

Background Idiopathic and secondary megacolon (MC) and megarectum (MR) in adults is associated with persistent bowel dilatation and reduced intestinal motility. Little is known about the optimal treatment of this rare disease. Therefore, we retrospectively analysed long-term data from these patients in 5 community and university hospitals, focusing on conservative versus surgical treatment. Methods Patient records from 7/2004 to 9/2021 were screened for colorectal diseases with severe constipation and persistent megacolon ≥ 9.0 cm and/or megarectum ≥ 6.5 cm. Follow up-data was collected through telephone interviews and written surveys. ClinicalTrialsgov NCT04340856. Results Sixty-seven patients with idiopathic (n=10) and secondary (n=57) MC or MR were identified with only 20 of 67 patients (29.9%) correctly diagnosed. Mean/median age was 64/69 (range 18–93) years. Thirty-two patients were treated with laxative regimens, and 35 underwent surgery (colostomy: n=12, segmental resection, or hemicolectomy: n=10, (sub)total colectomy: n= 13) after conservative treatment attempts in 32/35 (91.4%). The mean/median follow-up was 4.2/2.7 (range 0.1–17.0) years. The readmission rate for MC-associated symptoms was significantly higher after conservative treatment than after surgical therapy at 12 (0.84 vs. 0.36 per patient, p=0.036), 24 (1.00 vs. 0.52, p=0.048) and 36 (1.13 vs. 0.58, p=0.047) months, as was the number of patients with persistent laxative dependence (28/32 (87.5%) vs. 19/33 (57.6%); p = 0.007). Therapy-associated adverse events (Clavien-Dindo classification) were documented more often in surgically treated patients (11/35, 31.4%) (p=0.025). Conclusion Surgical treatment may be considered earlier if idiopathic or secondary MC or MR is correctly diagnosed, and conservative treatment has been attempted.

Background: Patients with active nonvariceal upper gastrointestinal bleeding (NVUGIB) usually require urgent endoscopic treatment. Standard therapy (ST) using haemoclip + / − epinephrine injection is not always successful. Bipolar haemostatic forceps (HemoStat/Pentax®) are an approved medical device for the treatment of gastrointestinal bleeding. However, their use as a primary endoscopic treatment for active NVUGIB has not yet been proven in a randomized prospective study. Methods: This is a prospective, randomized, multicentre superiority trial (n ≥ 5). Patients with active NVUGIB will be randomized (1:1) to ST and to experimental therapy (ET) by application of bipolar haemostatic forceps. In the case of failed initial treatment within 15 min, crossover treatment will be attempted first. Rescue treatment (e.g. via over-the-scope-clip) will then be allowed after 30 min. All patients will also receive standard therapy with proton pump inhibitors. Forty-five patients per treatment arm are required to demonstrate an absolute difference of 25.4% with a power of 80% and a significance level of 0.05. Discussion: The hypothesis of the study is that bipolar haemostatic forceps are superior to ST in terms of successful primary haemostasis and the absence of recurrent bleeding within 30 days (combined endpoint). The 1:1 randomization is also ethically justifiable for this study, as both procedures are approved for the intervention in question. To further increase the safety of the patients in the study, crossover treatment and rescue treatment are planned. The prospective design seems feasible in a reasonable time frame (recruitment period of 12 months), as nonvariceal upper gastrointestinal bleeding is common. Anticoagulants and/or antiplatelet drugs could be an important confounding factor in the statistical analysis that needs to be taken into account and calculated if necessary. In conclusion, this randomized, prospective, multicentre study could make an important contribution to answering the question of whether bipolar haemostatic forceps could be the first-line therapy in the endoscopic treatment of stage Forrest I a + b NVUGIB. Trial registration: ClinicalTrials.gov NCT05353062. Registered on April 30 2022.

Background: Endoscopic ultrasound-guided biliary drainage (EUS-BD) was associated with better clinical success and a lower rate of adverse events (AEs) than fluoroscopy-guided percutaneous transhepatic biliary drainage (PTBD) in recent single center studies with mainly retrospective design and small case numbers (< 50). The aim of this prospective European multicenter study is to compare both drainage procedures using ultrasound-guidance and primary metal stent implantation in patients with malignant distal bile duct obstruction (PUMa Trial). Methods: The study is designed as a non-randomized, controlled, parallel group, non-inferiority trial. Each of the 16 study centers performs the procedure with the best local expertise (PTBD or EUS-BD). In PTBD, bile duct access is performed by ultrasound guidance. EUS-BD is performed as an endoscopic ultrasound (EUS)-guided hepaticogastrostomy (EUS-HGS), EUS-guided choledochoduodenostomy (EUS-CDS) or EUS-guided antegrade stenting (EUS-AGS). Insertion of a metal stent is intended in both procedures in the first session. Primary end point is technical success. Secondary end points are clinical success, duration pf procedure, AEs graded by severity, length of hospital stay, re-intervention rate and survival within 6 months. The target case number is 212 patients (12 calculated dropouts included). Discussion: This study might help to clarify whether PTBD is non-inferior to EUS-BD concerning technical success, and whether one of both interventions is superior in terms of efficacy and safety in one or more secondary endpoints. Randomization is not provided as both procedures are rarely used after failed endoscopic biliary drainage and study centers usually prefer one of both procedures that they can perform best. Trial registration: ClinicalTrials.gov ID: NCT03546049 (22.05.2018).