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Common bile duct size in malignant distal obstruction and lumen-apposing metal stents: a multicenter prospective study

ABSTRACT: Background and study aims

SUBMITTER: Rimbas M

PROVIDER: S-EPMC8589552 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Palliation of malignant distal colonic obstruction via percutaneous endoscopic colostomy using a lumen-apposing metal stent.

Project description:Video 1Palliation of malignant distal colonic obstruction via a percutaneous endoscopic colostomy using a lumen-apposing metal stent.

| S-EPMC8646133 | biostudies-literature

Endoscopic ultrasound-guided choledochoduodenostomy using single-step lumen-apposing metal stents for primary drainage of malignant distal biliary obstruction (SCORPION-p): a prospective pilot study.

Project description:Background This study aimed to assess the safety and feasibility of endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) using a lumen-apposing metal stent (LAMS) as a primary drainage strategy in patients with distal malignant biliary obstruction (MBO).Methods A prospective, single-center, pilot study was conducted in patients with pathology-confirmed MBO without gastric outlet obstruction. The primary outcome was technical success. Secondary outcomes included clinical success, adverse events (AEs), and reinterventions. The study was registered in the Netherlands Trial Registry (registry number NL9757).Results 22 patients were enrolled (median age 69.5 years [interquartile range 64-75.3]). Technical success was achieved in 20/22 patients (91 %). AEs occurred in one patient, namely perforation following inadequate stent deployment (5 %), which was treated in the same procedure. Clinical success was achieved in 19/22 patients (86 %). Stent dysfunction was observed in 11/20 patients (55 %) after technically successful EUS-CDS: two patients were treated conservatively and nine patients underwent reintervention(s). One patient died within ≤ 30 days due to fulminant disease progression.Conclusions The results confirmed the safety and feasibility of EUS-CDS using LAMS as a primary drainage strategy. The high incidence of stent dysfunction should be improved before EUS-CDS with LAMS can be seen as a valid alternative to endoscopic retrograde cholangiopancreatography.

| S-EPMC11321721 | biostudies-literature

Aspirin for metal stent in malignant distal common bile duct obstruction (AIMS): study protocol for a multicenter randomized controlled trial.

Project description:BACKGROUND:Endoscopic retrograde biliary drainage (ERBD) is the treatment of choice for patients with malignant distal common bile duct (CBD) obstruction. Self-expandable metal stents (SEMS), which are commonly used in unresectable cases, have many clinical advantages, including longer stent patency. Although the expected patency of SEMS is around 8 months, it has recently been reported that the duration of SEMS' patency in patients using aspirin is prolonged. Our study, therefore, aims to investigate the effect of aspirin on SEMS' patency. METHODS/DESIGN:This is an investigator-initiated, prospective, multicenter, double-blind, randomized placebo-controlled trial that will be conducted from November 2017 in four tertiary centers in South Korea. We intend to include in our study 184 adult (aged ≥ 20 years) patients with malignant distal CBD obstruction for whom ERBD with SEMS was successfully performed. The patients will be randomly allocated to two groups, which will comprise patients who have either taken 100 mg aspirin or a placebo for 6 months after index ERBD. The primary outcome will be the rate of stent dysfunction, and the secondary outcomes will be the duration of patency, the rate of reintervention, and the occurrence of adverse events. DISCUSSION:The aspirin for metal stents in malignant distal common bile duct obstruction (AIMS) study should determine the efficacy of aspirin in maintaining metal-stent patency in patients with malignant distal CBD obstructive. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT03279809. Registered on 5 September 2017.

| S-EPMC6990585 | biostudies-literature

Multicenter study of lumen-apposing metal stents with or without pigtail in endoscopic ultrasound-guided biliary drainage for malignant obstruction-BAMPI TRIAL: an open-label, randomized controlled trial protocol.

Project description:BackgroundIt is unclear whether the insertion of an axis-orienting double-pigtail plastic stent (DPS) through biliary lumen-apposing meal stent (LAMS) in EUS-guided choledochoduodenostomy (CDS) improves the stent patency. The aim of this study is to determine whether this technical variant offers a clinical benefit in EUS-guided biliary drainage (BD) for the management of distal malignant biliary obstruction.Methods/designThis is a multicenter open-label, randomized controlled trial with two parallel groups. Eighty-four patients with malignant biliary obstruction will undergo EUS-BD (CDS type) using LAMS in 7 tertiary hospitals in Spain and will be randomized to the LAMS and LAMS plus DPS groups. The primary endpoint is the rate of recurrent biliary obstruction, as a stent dysfunction parameter, detected during follow-up. Secondary endpoints: technical and clinical success (reduction in bilirubin > 50% within 14 days of stent placement), safety, and others (number of reinterventions, time to biliary obstruction, prognostic factors, survival rate).DiscussionThe BAMPI trial has been designed to determine whether the addition of a coaxial axis-orienting DPS through LAMS is superior to LAMS alone to prevent stent dysfunction.Trial registrationClinicalTrials.gov NCT04595058 . Registered on October 14, 2020.

| S-EPMC8874735 | biostudies-literature

The use of double-pigtailed stents to relieve obstruction of a previous endoscopic gastrojejunal lumen-apposing metal stent.

Project description:Video 1EGD, which showed obstructed distal flange of the gastrojejunal lumen-apposing metal stent (LAMS) by the contralateral jejunal wall. Two double-pigtail stents were placed across the LAMS to relieve the obstruction.

| S-EPMC8573536 | biostudies-literature

EUS-guided biliary drainage with a novel electrocautery-enhanced lumen apposing metal stent as first approach for distal malignant biliary obstruction: a prospective study.

Project description:Background and study aims Endoscopic retrograde cholangiopancreatography (ERCP) represents the gold standard for jaundice palliation in malignant biliary obstruction (MBO) patients. Biliary drainage using electrocautery lumen apposing metal stent (EC-LAMS) is currently a well-established procedure when ERCP fails. We aimed to assess the technical and clinical success of a new EC-LAMS as the first approach to the palliation of malignant jaundice due to MBO in patients unfit for surgery. Patients and methods Twenty-five consecutive patients undergoing endoscopic-guided biliary drainage with the new EC-LAMS were prospectively enrolled. Clinical success was defined as bilirubin level decrease > 15 % 24 hours after EC-LAMS placement. Results Mean age was 76.6 ± 11.56 years, and male patients were 10 (40 %). EC-LAMS placement was technically feasible in 24 patients (96 %) and clinical success rate was 100 %. Only one patient (4 %) experienced a misplacement rescued by an immediate second EC-LAMS placement. The mean duration of hospital stay was 4.66 ± 4.22 days. The median overall survival was 7 months (95 % CI 1-7). Conclusions In this preliminary study, the new EC-LAMS seems to allow a single-step palliative endoscopic therapy in patients affected by jaundice due to MBO, with high technical and clinical success and low adverse events. Further large prospective studies are warranted to validate these results.

| S-EPMC9286767 | biostudies-literature

Drainage of gastric intramural abscesses using lumen-apposing metal stents.

Project description:Video 1Decompression of gastric intramural abscesses using LAMS.

| S-EPMC8430045 | biostudies-literature

Hepaticoduodenostomy (Right Intrahepatic Biliary Duct) Using a Lumen-Apposing Metal Stent Hepatoduodenostomia (ducto biliar intrahepatico direito) com protese lumen-apposing

Project description: Not available

| S-EPMC10305248 | biostudies-literature

A randomized trial comparing winged versus conventional plastic stents for malignant bile duct strictures.

Project description:BACKGROUND AND STUDY AIMS?:Stent insertion at endoscopic retrograde cholangiopancreatography (ERCP) is an established therapy for managing malignant biliary obstruction. Conventional plastic stents with a tubular design are most commonly used despite limited patency. Plastic stents with a winged design may theoretically increase the duration of stent patency. The aim of this study was to compare stent patency of the winged versus conventional plastic stents in patients with malignant biliary obstruction. PATIENTS AND METHODS?:A prospective, randomized subject-blinded trial was conducted. Patients with malignant biliary obstruction were randomized (1:1) to either a 10 French winged stent or 7 or 10 French conventional plastic stent. Strictures greater than 1?cm distal to the hilum were included. Patients were followed clinically to determine the frequency of stent failure until surgery, death or study closure. RESULTS?:Fifty-eight patients were enrolled. Following 9 exclusions, 49 patients were randomized to a winged (n?=?23) or conventional stent (n?=?26). Median time to stent failure was 89 (95?% CI 26-NA) vs 143 (95?% CI 33?-?266) days ( P ?=?0.963) for the winged and conventional group, respectively. Stent failure for the winged group occurred in 11 (48?%) compared to 14 (54?%) in the conventional group.?Median survival was 123 (95?% CI 81?-?189) vs 342 days (95?% CI 123?-?704) (p?=?0.084) in the winged and conventional group respectively. There were no procedure related adverse events. CONCLUSIONS?:Improvement in stent patency was not seen with the winged stent when compared to the conventional plastic stent.

| S-EPMC5500122 | biostudies-literature

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).

Project description:BackgroundEndoscopic 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).MethodsThe 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).DiscussionThis 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 registrationClinicalTrials.gov ID: NCT03546049 (22.05.2018).

| S-EPMC9612485 | biostudies-literature

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