View clinical trials related to Gastric Outlet Obstruction.
Filter by: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.
The goal of this interventional study is to learn about the outcomes between two options for the management of malignant gastric outlet obstruction.
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.
This study is intended to investigate whether roux-en-y bypass surgery is superior to conventional loop gastrojejunostomy for Malignant gastric outlet obstruction in terms of tolerance to solid food intake. We hypothesize that roux-en-y bypass will be associated with improved solid food intake in the first 30 days after surgery.
A prospective, multi-center, single-arm study for unresectable malignant gastric outlet obstruction with EUS-guided double-balloon-occluded gastrojejunostomy bypass (EPASS)
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.
Gastric outlet obstruction (GOO) is a common complication of various types of malignancy arising from the pancreas, bile ducts, retroperitoneum and distal stomach. As these tumours grow they may invade or compress the distal stomach or gastric outlet causing patients to develop the classical manifestations of GOO including vomiting, weight loss, electrolyte disturbances loss of quality of life as well as a reduced life expectancy. Until recently these patients were managed using either endoscopic stenting or surgery. Laparoscopic gastrojejunostomy (L-GJ) has been regarded as the golden standard in the management of GOO. However surgery is invasive and may lead to peri-operative complications and longer hospitalization which further greatly impacts on the quality of life of these patients in which survival is already greatly impaired by their oncological problem. Recently it has been shown that a special stent can be utilized to circumvent the tumour obstruction without the need for surgery. This technique utilizes endoscopic ultrasound to connect the stomach to the jejunum at a site distal to the tumour obstruction. This techniques is minimally invasive compared to surgery. In a large retrospective propensity matched study we recently compared endoscopic ultrasound placement of an AXIOS stent to laparoscopic surgery and could show that the EUS-guided approach led to less complications (2.6 vs 26%) and shorter hospital stay compared to surgery.1 Our study and that of other groups, has led the European Society of Gastrointestinal Endoscopy (ESGE) to recommend that EUS-guided gastrojejunostomy (EUS-GJ) can be considered for patients with malignant GOO as an alternative for surgery and endoscopic stenting, acknowledging that further randomized controlled trials comparing the EUS-GJ approach to surgery, are necessary.2 Based on the above clinical need we set out to design a multicentre international trial with the main aim of comparing EUS-guided gastrojejunostomy to laparoscopic gastroenterostomy. The planned study has two components: 1. Randomized study (EATING RCT)- patients that meet the strict inclusion criteria for the (EATING-RCT) will be randomized to either EUS-GJ or L-GJ. 2. Patients in whom inclusion criteria for the RCT are not met, will be invited to participate in the observational arm of the study (EATING-C) comparing EUS-GJ, enteral stenting and surgical gastrojenostomy in a "real world scenario" setting. With this combined design we aim to include all patients with malignant gastric outlet obstruction undergoing treatment. This will be an international multicentre effort, with expert centers in Belgium and other countries in Europe, including UZ Brussel (BE), UCL (BE), Hôpital Erasme (BE), UCL Namur (BE), UZ Gent (BE), Alicante (Spain), Gemelli Rome (Italy), San-Rafaelle Milan (Italy) and G.B. Rossi University Hospital Verona (Italy) as participating centres (total n=11). This envisaged investigator driven study will be performed using an AXIOS stent produced by the company BOSTON SCIENTIFIC. This stent is registered in Europe and CE approved for the drainage of pancreatic fluid collections, the gall bladder and bile ducts. As described above we and other groups have used this product off-label to succesfully perform EUS-guided GJ. High-quality randomized controlled data are however required that will be generated in the proposed EATING RCT study. It is expected that the data, generated by the EATING RCT trial will contribute significantly to resolve the current question regarding the best management of patients with GOO. Ultimately the objective should be to provide high quality affordable care that is minimally invasive to cancer patients with GOO. Such high quality data will also be crucial when applying for registration and CE approval of this product for use in the management of GOO .
Gastric outlet obstruction (GOO), defined by a mechanical obstruction of the duodenum, pylorus, or antrum, may result from various diseases. GOO was caused by underlying malignancy in up to 85% of patients, most of which could be attributed to pancreatic cancer. Malignant GOO may increase morbidity, reducing quality of life, and significantly influencing tolerability and efficacy of oncologic treatments. Before the advent of EUS-guided gastroenterostomy (EUS-GE), placement of enteral self-expandable metallic stents (SEMS) or surgical gastroenterostomy (SGE) are the standard of care for many years. The main shortcoming of enteral SEMS placement is recurrent GOO due to tumor ingrowth/overgrowth, which occurs in the majority of patients who survive longer than 6 months. On the other hand, the main limitation of SGE is its invasive nature, especially in such patients with advanced malignancies and poor nutritional status. In addition, SGE is associated with frequent complications, such as perioperative infections and gastroparesis. EUS-guided gastroenterostomy (EUS-GE) is a novel procedure for palliation of malignant GOO. Several systematic reviews and meta-analysis demonstrated the feasibility, efficacy and safety of EUS-GE. Compared with laparoscopic GE (LGE), EUS-GE not only had almost identical technical and clinical success but also reduced time to oral intake, shorter median hospital stay, and lower rate of adverse events. However, data directly comparing EUS-GE to LGE are limited. We aimed to compare clinical outcomes between EUS-GE and LGE in the palliation of malignant GOO under a randomized setting.
Gastric outlet obstruction (GOO) occurs commonly in malignancies involving the periampullary region (cancers originating in the head of the pancreas, duodenum, bile duct, or ampulla) or the distal stomach. GOO not only causes debilitating symptoms such as nausea, vomiting, inability to tolerate oral intake, and prevents adequate nutritional intake. Therefore, providing therapy for GOO is imperative to improve the quality of life, and nutritional status of these patients, as well as allow them to continue receiving their cancer treatment
Malignant gastric outlet obstruction (GOO) results from the mechanical obstruction of the duodenum or distal stomach from an underlying cancer. The consequences of GOO are abdominal pain, nausea, vomiting, anorexia, inability to maintain an oral diet and weight loss, with associated poor quality of life and inability to continue with cancer therapy. 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.