Technical feasibility and clinical success of direct "free hand" EUS-guided gastroenterostomy in patients with gastric outlet obstruction

Background and study aims  Endoscopic ultrasound-guided gastroenterostomy (EUS-GE) with lumen-apposing metal stents (LAMS) appears to be a promising intervention in management of gastroduodenal out obstruction (GOO), particularly for patients for whom surgery is high risk or in a palliative setting. This study aimed to evaluate the technical feasibility, procedure-associated adverse events (AEs), and clinical outcome of direct "free hand" EUS-GE. Patients and methods  This retrospective two-center study included patients who underwent direct "free hand" EUS-GE (April 2017 to March 2021) investigating technical success (correctly placed LAMS), clinical outcome (successful oral nutrition), and management of procedure-associated AEs. "Free hand" was defined as the use of the electrocautery enhanced stent delivery system alone without additional guidewire-assistance for EUS-GE creation. Results  Forty-five patients (58 % women/42 % men; mean age 65 years) with malignant (n = 39), benign (n = 4) or unclear (n = 2) GOO underwent direct "free hand" EUS-GE. The technical success rate was 98 % (44/45). Of the patients, 95% (42/44) had less vomiting and increased ability to tolerate oral food intake after the intervention. In one patient, a second EUS-GE was necessary to achieve sufficient clinical improvement. Procedure-associated AEs were observed in 24 % (11/45) of cases including stent misplacement (n = 7), leakage (n = 1), development of a gastrojejunocolic fistula (n = 1), and bleeding (n = 2), which could be all managed endoscopically. Conclusions  Direct EUS-GE has a favorable risk-benefit profile for patients with GOO, showing high technical success rates, manageable AEs, and rapid symptom relief

Digital single-operator pancreatoscopy for the treatment of symptomatic pancreatic duct stones: a prospective multicenter cohort trial

BACKGROUND  Digital single-operator pancreatoscopy (DSOP)-guided lithotripsy is a novel treatment modality for pancreatic endotherapy, with demonstrated technical success in retrospective series of between 88 % and 100 %. The aim of this prospective multicenter trial was to systematically evaluate DSOP in patients with chronic pancreatitis and symptomatic pancreatic duct stones. METHODS  Patients with symptomatic chronic pancreatitis and three or fewer stones ≥ 5mm in the main pancreatic duct (MPD) of the pancreatic head or body were included. The primary end point was complete stone clearance (CSC) in three or fewer treatment sessions with DSOP. Current guidelines recommend extracorporeal shock wave lithotripsy (ESWL) for MPD stones > 5 mm. A performance goal was developed to show that the CSC rate of MPD stones using DSOP was above what has been previously reported for ESWL. Secondary end points were pain relief measured with the Izbicki pain score (IPS), number of interventions, and serious adverse events (SAEs). RESULTS  40 chronic pancreatitis patients were included. CSC was achieved in 90 % of patients (36/40) on intention-to-treat analysis, after a mean (SD) of 1.36 (0.64) interventions (53 procedures in total). The mean (SD) baseline IPS decreased from 55.3 (46.2) to 10.9 (18.3). Overall pain relief was achieved in 82.4 % (28/34) after 6 months of follow-up, with complete pain relief in 61.8 % (21/34) and partial pain relief in 20.6 % (7/34). SAEs occurred in 12.5 % of patients (5/40), with all treated conservatively. CONCLUSION  DSOP-guided endotherapy is effective and safe for the treatment of symptomatic MPD stones in highly selected patients with chronic pancreatitis. It significantly reduces pain and could be considered as an alternative to standard ERCP techniques for MPD stone treatment in these patients

Percutaneous transhepatic or endoscopic ultrasound-guided biliary drainage in malignant distal bile duct obstruction using a self-expanding metal stent: Study protocol for a prospective European multicenter trial (PUMa trial)

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

Technical success, resection status, and procedural complication rate of colonoscopic full-wall resection: a pooled analysis from 7 hospitals of different care levels

Abstract Introduction Endoscopic full-thickness resection (eFTR) using the full-thickness resection device (FTRD®) is a novel minimally invasive procedure that allows the resection of various lesions in the gastrointestinal tract including the colorectum. Real-world data outside of published studies are limited. The aim of this study was a detailed analysis of the outcomes of colonoscopic eFTR in different hospitals from different care levels in correlation with the number of endoscopists performing eFTR. Material and methods In this case series, the data of all patients who underwent eFTR between November 2014 and June 2019 (performed by a total of 22 endoscopists) in 7 hospitals were analyzed retrospectively regarding rates of technical success, R0 resection, and procedure-related complications. Results Colonoscopic eFTR was performed in 229 patients (64.6% men; average age 69.3 ± 10.3 years) mainly on the basis of the following indication: 69.9% difficult adenomas, 21.0% gastrointestinal adenocarcinomas, and 7.9% subepithelial tumors. The average size of the lesions was 16.3 mm. Technical success rate of eFTR was achieved in 83.8% (binominal confidence interval 78.4–88.4%). Overall, histologically complete resection (R0) was achieved in 77.2% (CI 69.8–83.6%) while histologically proven full-wall excidate was confirmed in 90.0% (CI 85.1–93.7%). Of the resectates obtained (n = 210), 190 were resected en bloc (90.5%). We did not observe a clear improvement of technical success and R0 resection rate over time by the performing endoscopists. Altogether, procedure-related complications were observed in 17.5% (mostly moderate) including 2 cases of acute gangrenous appendicitis requiring operation. Discussion In this pooled analysis, eFTR represents a feasible, effective, and safe minimally invasive endoscopic technique

Technical success, resection status, and procedural complication rate of colonoscopic full-wall resection: a pooled analysis from 7 hospitals of different care levels

Introduction!#!Endoscopic full-thickness resection (eFTR) using the full-thickness resection device (FTRD®) is a novel minimally invasive procedure that allows the resection of various lesions in the gastrointestinal tract including the colorectum. Real-world data outside of published studies are limited. The aim of this study was a detailed analysis of the outcomes of colonoscopic eFTR in different hospitals from different care levels in correlation with the number of endoscopists performing eFTR.!##!Material and methods!#!In this case series, the data of all patients who underwent eFTR between November 2014 and June 2019 (performed by a total of 22 endoscopists) in 7 hospitals were analyzed retrospectively regarding rates of technical success, R0 resection, and procedure-related complications.!##!Results!#!Colonoscopic eFTR was performed in 229 patients (64.6% men; average age 69.3 ± 10.3 years) mainly on the basis of the following indication: 69.9% difficult adenomas, 21.0% gastrointestinal adenocarcinomas, and 7.9% subepithelial tumors. The average size of the lesions was 16.3 mm. Technical success rate of eFTR was achieved in 83.8% (binominal confidence interval 78.4-88.4%). Overall, histologically complete resection (R0) was achieved in 77.2% (CI 69.8-83.6%) while histologically proven full-wall excidate was confirmed in 90.0% (CI 85.1-93.7%). Of the resectates obtained (n = 210), 190 were resected en bloc (90.5%). We did not observe a clear improvement of technical success and R0 resection rate over time by the performing endoscopists. Altogether, procedure-related complications were observed in 17.5% (mostly moderate) including 2 cases of acute gangrenous appendicitis requiring operation.!##!Discussion!#!In this pooled analysis, eFTR represents a feasible, effective, and safe minimally invasive endoscopic technique

Kosten endoskopischer Leistungen der Gastroenterologie im deutschen DRG-System – 5-Jahres-Kostendatenanalyse des DGVS-Projekts

Background In the German hospital reimbursement system (G-DRG) endoscopic procedures are listed in cost center 8. For reimbursement between hospital departments and external providers outdated or incomplete catalogues (e.g. DKG-NT, GOZ) have remained in use. We have assessed the cost for endoscopic procedures in the G-DRG-system. Methods To assess the cost of endoscopic procedures 74 hospitals, annual providers of cost-data to the Institute for the Hospital Remuneration System (InEK) made their data (2011-2015; 21 KHEntgG) available to the German-Society-of-Gastroenterology (DGVS) in anonymized form (4873 809 case-data-sets). Using cases with exactly one endoscopic procedure (n = 274 186) average costs over 5 years were calculated for 46 endoscopic procedure-tiers. Results Robust mean endoscopy costs ranged from 230.56 (sic) for gastroscopy (144 666 cases), 276.23 (sic) (n = 32294) for a simple colonoscopy, to 844.07 (sic) (n = 10150) for ERCP with papillotomy and plastic stent insertion and 1602.37 (sic) (n = 967) for ERCP with a self-expanding metal stent. Higher costs, specifically for complex procedures, were identified for University Hospitals. Discussion For the first time this catalogue for endoscopic procedure-tiers, based on 21 KHEntgG data-sets from 74 InEK-calculating hospitals, permits a realistic assessment of endoscopy costs in German hospitals. The higher costs in university hospitals are likely due to referral bias for complex cases and emergency interventions. For 46 endoscopic procedure-tiers an objective cost-allocation within the G-DRG system is now possible. By international comparison the costs of endoscopic procedures in Germany are low, due to either greater efficiency, lower personnel allocation or incomplete documentation of the real expenses

EUS-guided drainage of pancreatic fluid collections using a novel lumen-apposing metal stent on an electrocautery-enhanced delivery system : a large retrospective study (with video)

BACKGROUND AND AIMS: A lumen-apposing, self-expanding metal stent incorporated in an electrocautery-enhanced delivery system for EUS-guided drainage of pancreatic fluid collections (PFCs) recently has become available. The aim of this study was to analyze the safety and clinical effectiveness of this newly developed device in this clinical setting. METHODS: This was a retrospective analysis of all consecutive patients with PFCs who underwent EUS-guided drainage using the study device in 13 European centers. RESULTS: Ninety-three patients with PFCs (80% with complex collections) underwent drainage using the study device. Penetration of the PFC was accomplished directly with the study device in 74.2% of patients, and successful stent placement was accomplished in all but 1 patient, mostly without fluoroscopic assistance. Direct endoscopic necrosectomy (DEN) was carried out in 31 of 52 cases (59.6%) of walled-off necrosis and in 2 of 4 cases (50%) of acute peripancreatic fluid collection. Complete resolution of the PFC was obtained in 86 cases (92.5%), with no recurrence during follow-up. Treatment failure occurred in 6 patients because of persistent infection requiring surgery (n = 3), perforation and massive bleeding caused by the nasocystic drainage catheter (NCDC) (n = 2), and the need for a larger opening to extract large necrotic tissue pieces (n = 1). Major adverse events occurred in 5 patients (perforation and massive bleeding caused by the NCDC in 2 patients, 1 pneumoperitoneum and 1 stent dislodgement during DEN, and 1 postdrainage infection) and were mostly not related to the drainage procedure. CONCLUSIONS: EUS-guided drainage with the electrocautery-enhanced delivery system is a safe, easy to perform, and a highly effective minimally invasive treatment modality for PFCs

The safety and efficacy of a new 20-mm lumen apposing metal stent (lams) for the endoscopic treatment of pancreatic and peripancreatic fluid collections: a large international, multicenter study

BACKGROUND: Lumen apposing metal stent (LAMS) allows an easy access to peripancreatic fluid collections (PPFCs) and the possibility of performing direct endoscopic necrosectomy (DEN). The aim of our study was to evaluate the safety and efficacy of a new 20-mm LAMS in the management of PPFCs. This novel stent represents the largest diameter LAMS available on the market to date. METHODS: This is an international, multicenter retrospective study involving 20 centers. Consecutive patients who underwent EUS-guided PPFC drainage using a 20-mm LAMS were included. Primary outcomes were technical and clinical success. Secondary outcomes were rate and the severity of adverse events. RESULTS: A total 105 patients underwent PPFC drainage using the new 20-mm LAMS and 106 LAMS were placed. Technical success was 100% (106/106). 7/105 patients died due to causes not related to the stent. Clinical success was achieved in 92/98 patients (93.9%). Significant adverse events occurred in 8/98 patients (8.16%): 4 cases (4.08%) of bleeding, 3 cases (3.06%) of suprainfection, 1 case of gastric outlet obstruction. CONCLUSIONS: This multicenter study demonstrated acceptable rates of technical and clinical success using a new 20-mm LAMS for PPFC, including walled-off pancreatic necrosis (WOPN). The results of our study suggest that a new 20-mm LAMS is non-inferior in terms of safety, efficacy, and adverse events as compared to smaller diameter LAMS in the management of PPFCs, including pancreatic psuedocysts (PP) and WOPN. Randomized controlled studies will be needed to determine the ideal size of LAMS need to achieve the greatest clinical benefit with the minimized risk exposure for this high-risk patient population