Clinical Research Directory

Magnet System Gastric Outlet Obstruction Study

Evaluate the performance and safety of the GT Metabolic Magnet System to create side-to-side gastroenteral magnetic compression anastomosis (gastroenterostomy).

Malignant Gastric Outlet Obstruction Study With Stomach Partitioning (GO-PART)

The goal of this clinical trial is to evaluate whether stomach-partitioning gastrojejunostomy (SPGJ) more effectively reduces postoperative delayed gastric emptying (DGE) compared to conventional gastrojejunostomy (CGJ) in patients with unresectable stage IV gastric cancer accompanied by malignant gastric outlet obstruction (MGOO). This multicenter randomized trial aims to establish a new surgical standard that enhances recovery and quality of life in advanced gastric cancer. The main questions are: 1. Does SPGJ significantly decrease DGE compared with CGJ? 2. Does SPGJ enable faster food tolerance, shorter hospital stay, and earlier chemotherapy? Researchers will compare two arms - SPGJ and CGJ - to determine differences in postoperative gastric emptying, hospital course, complications, and survival outcomes. Participants Eligible participants are adults aged 20-85 years with histologically proven unresectable gastric adenocarcinoma limited to the lower third of the stomach and endoscopic or radiologic evidence of obstruction. Patients with total bowel obstruction, middle-third tumor extension, emergency conditions, or severe malnutrition (albumin \< 2.5 g/L) are excluded. Interventions * CGJ arm: Standard laparoscopic gastrojejunostomy using a 60 mm stapler without partitioning. * SPGJ arm: Laparoscopic transverse gastric partitioning 5 cm proximal to the tumor with a 2 cm bridge at the lesser curvature, followed by stapled gastrojejunostomy. All operations follow standardized training videos and pretrial workshops to ensure consistency across 32 Korean university hospitals. Study Design This is a prospective, randomized controlled multicenter trial (KLASS 16). After intraoperative diagnostic laparoscopy confirms eligibility, participants are randomized by a secure web-based block system stratified by hospital. A total of 144 patients (72 per arm) will be enrolled, ensuring 90% statistical power based on expected DGE rates (CGJ 34.6% vs SPGJ 3.8%). Endpoints * Primary endpoint: Incidence of DGE within 30 days (ISGPS criteria). * Secondary endpoints: Day of oral tolerance (GOO score ≥ 2), hospital stay, Clavien-Dindo ≥ II complications, mechanical obstruction recurrence, 6 and 12 month overall survival, and quality of life. Data Collection and Analysis Data will include postoperative nutrition recovery, complication grades, and survival follow-up. Analyses will utilize Chi square or Fisher's exact test for DGE rates and Kaplan-Meier with log rank testing for survival. Logistic regression will identify DGE risk factors. Duration Total 3 years: 6 months preparation, 1 year enrollment, 1 year follow up, and 6 months for data analysis and reporting. Expected Outcomes SPGJ is expected to reduce DGE by \> 70%, shorten hospital stay by \~3 days, and enable earlier chemotherapy, thereby improving palliative care outcomes and overall patient quality of life. The KLASS 16 trial will provide the first multicenter, Level I evidence to determine whether SPGJ should replace CGJ as the standard palliative procedure for MGOO.

AXIOS™ Gastroenterostomy for Gastric Outlet Obstruction IDE

To investigate the safety and technical success of EUS-guided gastroenterostomy (EUS-GE) using the AXIOSTM lumen-apposing Metal Stent for the management of symptoms associated with gastric outlet obstruction from malignant unresectable neoplasm.

GT Metabolic Magnet System in Adults With Gastrointestinal Disorders

Evaluate the performance and safety of the GT Metabolic Magnet System for the creation of side-to-side compression anastomosis in the stomach and/or small bowel in conditions requiring an anastomosis as part of the underlying clinical treatment.

Prospective Registry Of Therapeutic EndoscopiC ulTrasound

This registry aims to analyze long-term outcomes of therapeutic EUS (T-EUS) procedures, as well as to describe clinical and technical variables potentially predicting clinical success or adverse events, for a better selection of ideal candidates. The study also includes standard alternatives to T-EUS procedures for outcomes comparison.

Management of Malignant Gastric Outlet Obstruction Between Surgery and Endoscopy

The aim of this observational study is to compare the outcomes of three different procedures performed for the management of malignant Gastric Outlet Obstruction due to Pancreatic Cancer. Patients who undergo: * Surgical gastroenterostomy * Endoscopic placement of a self-expanding metallic stent * EUS-guided gastroenterostomy in accordance with standard clinical practice, will be enrolled to evaluate potential differences between the procedures in terms of clinical success, eating experience, chemotherapy tolerance, and nutritional status during follow-up. Participants will be asked to complete a quality of life questionnaire at baseline and during follow-up; however, no additional procedures will be conducted as a result of participation in the study.

Endoscopic Ultrasound-guided Large Diameter Lumen-apposing Metal Stent Gastro-gastrostomy for Bypass Reversal in Patients With Roux-en-y Gastric Bypass

The primary objective of this open-label pilot study is to investigate whether an endoscopically placed lumen apposing metal stent is an effective alternative to surgery in patients that have a clear indication for reversal of their gastric bypass.

Novel Balloon-Assisted vs Direct Technique in EUS-Guided Gastroenterostomy

Gastric outlet obstruction (GOO) refers to mechanical blockage at the pylorus or duodenum, most commonly caused by unresectable malignancies of the stomach, duodenum, or pancreas. At the time of diagnosis, the majority of lesions are no longer amenable to curative resection, and median survival ranges from only 11.3 to 21.3 weeks. Throughout the disease course, patients develop nausea, vomiting, and severe malnutrition, which markedly impair quality of life. Current strategies to relieve obstruction include endoscopic stent placement and surgical gastrojejunostomy; however, each is associated with distinct drawbacks, such as stent occlusion, prolonged operative times, and high complication rates. Endoscopic ultrasound-guided gastroenterostomy (EUS-GE) is a minimally invasive technique in which a gastric-jejunal anastomosis is created under real-time EUS guidance, bypassing the obstructed segment and establishing a gastrojejunal shortcut. Compared with conventional surgery or endoscopic luminal stenting, EUS-GE offers reduced procedural trauma and lower recurrence rates, providing GOO patients with an additional, less-invasive therapeutic option. Three main EUS-GE approaches have been described: the direct method, the balloon-assisted method, and the double-balloon-assisted method. The direct method requires large volumes of water instillation, posing hemodynamic risks in patients with cardiovascular or cerebrovascular disease. The double-balloon technique relies on expensive, specialized devices that have not yet been widely adopted. The conventional balloon-assisted method demands needle puncture of a partially inflated balloon, which compromises stability and can displace the target jejunum away from the gastric wall. All three techniques are technically demanding, limiting their broad clinical dissemination. The investigators therefore designed and previously reported a dedicated single-balloon-assisted device specifically for EUS-GE. This novel system aims to shorten procedure time, reduce intraprocedural water volume, and enhance procedural safety. The present prospective, multicenter, randomized controlled trial was undertaken to validate the clinical efficacy and safety of this new single-balloon-assisted technique compared with the conventional direct water-injection method.

Randomized Trial of EUS-guided Gastrojejunostomy and Surgical Gastrojejunostomy in Gastric Outlet Obstruction

Malignant gastric outlet obstruction (GOO) results from the mechanical obstruction of the duodenum or distal stomach from an underlying cancer. The aim of this study is to compare the clinical outcomes between surgical gastrojejunostomy and EUS-guided gastrojejunostomy in patients with malignant gastric outlet obstruction.