Active clinical trials for "Gastric Outlet Obstruction"

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.

Currently, there is limited multi-center data on endoscopic surgery outcomes in western populations. Evaluation of these measurement would help the investigators compare them to conventional treatment modalities within current tertiary facilities; and consequently help the investigators identify appropriate treatment techniques and improve clinical management of patients at Rutgers RWJMS. The purpose of this retrospective registry study is to assess long term data on efficacy, safety and clinical outcome of Endoscopic Surgery within the gastrointestinal tract.

Pyloric stenosis is a current condition in pediatric surgery. The medical management prior to surgery consists of ionic correction. The nasogastric tube is commonly used to prevent gastric fluid inhalation before surgery, but there is no study on it benefits in this specific use. Other studies suggest that utilization of a gastric tube in pyloric stenosis may increase the duration of the medical treatment. The aim of the study is to evaluate the benefit of the nasogastric tube to prevent respiratory complications. This retrospective, monocentric and descriptive study include all patients hospitalized for pyloric stenosis in the university hospital in Amiens between 2014 and 2021. Patients with and without nasogastric tube prior to surgery are compared, regarding respiratory complications define as use of antibiotic, or oxygen therapy or infection in the lungs X-ray before surgery. The investigators analyze pre-operative data: vomiting, dehydration, time to ionic disorders correction and pain, and also notice the length of hospital stay. Data during hospitalization are analyzed and will be noticed the last medical contact represent by the post-operative consultation.

Surgical gastrojejunostomy is the conventional treatment for palliating patients suffering from of inoperable malignant gastric outlet obstruction (GOO). Although, the procedure is associated with a high success and low re-intervention rates, there is a risk of morbidities (10% - 16%) and mortalities (7%). The placement of a pyloro-duodenal self-expandable metallic stent (DSEMS) is an alternative to surgery for the palliating these patients. As compared to surgery, the procedure is associated with shorter hospital stay, reduced morbidities and cost. However, the clinical efficacy of DSEMS is limited by several problems. In uncovered DSEMS, the long-term patency is reduced by tumor ingrowth leading to subsequent re-stenosis. In covered DSEMS, stent migration occurs at a frequency of 14 - 25% and it is a major obstacle to stent patency. As a result, randomized trials comparing uncovered DSEMS and partially or fully covered DSEMS in patients with malignant GOO have reported comparable stent patency between the two types of stents. Recently, the creation of a gastrojejunostomy under EUS (EUS-GJ) guidance using lumen-apposing stents has been described 12-16. The procedure was associated with a technical success rate of around 90% and clinical success of 85% to 100%. The procedure holds the potential to create a gastrojejunostomy without surgery. Furthermore, there is a low risk of tumor ingrowth and stent migration, thus improving the stent patency and reducing the need of re-intervention. However, there is limited data on how EPASS compares to endoscopic stenting. The aim of the current study is thus to compare prospective data on EPASS versus a historical group that received DSEMS.

gastric outlet obstruction tailored versus standard stents for malignant gastric outlet obstruction treatments

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 aimed to evaluate the safety and symptomatic outcomes achieved with Stapled Transanal Rectal Resection (STARR) compared to biofeedback training in patients with obstructed defecation syndrome (ODS).

Malignant gastric outlet obstruction can result from gastric adenocarcinoma, leading to intractable vomiting, nausea, and poor oral food intake. Although self-expandable metallic stent (SEMS) insertion has excellent technical and clinical success rates for relieving gastric outlet obstruction symptoms, the uncovered SEMS is susceptible to re-stenosis because of tumor ingrowth through openings between the stent wire filaments. Therefore, the most common reason for stent failure in uncovered stents is tumor ingrowth. The covered SEMS has a membrane that prevents ingrowth through the mesh wall and consequently shows lower rate of re-stenosis than uncovered SEMS. However, covered SEMS has a higher risk of stent migration compared to uncovered SEMS. Recent prospective, randomized study showed that there was no significant difference between uncovered and covered SEMS in terms of stent patency rate as well as technical and clinical success rates. Recently the investigators developed new covered SEMS for gastric outlet obstruction. This new covered SEMS has features that may contribute to reducing migration rate: 1) partially covered design; 2)less radial force in central portion of stent; 3) presence of lasso which enable position of stent to be adjusted after deployment; 4)presence of protrusion in both sides of stent. This prospective, randomized study aimed to compare the effectiveness and side effects of newly developed covered SEMS with those of uncovered SEMS in patients with malignant gastric outlet obstruction from gastric cancer.

Surgical gastrojejunostomy is the conventional treatment for palliating patients suffering from of inoperable malignant gastric outlet obstruction (GOO). Although, the procedure is associated with a high success and low re-intervention rates, there is a risk of morbidities (10% - 16%) and mortalities (7%). The placement of a pyloro-duodenal self-expandable metallic stent (SEMS) is an alternative to surgery for the palliating these patients. As compared to surgery, the procedure is associated with shorter hospital stay, reduced morbidities and cost. However, the clinical efficacy of SEMS is limited by several problems. In uncovered SEMS, the long-term patency is reduced by tumor ingrowth leading to subsequent re-stenosis. In covered SEMS, stent migration occurs at a frequency of 14-25% and it is a major obstacle to stent patency. As a result, randomized trials comparing uncovered stents and partially or fully covered stents in patients with malignant GOO have reported comparable stent patency between the two types of stents. Recently, the creation of a gastrojejunostomy under EUS (EUS-GJ) guidance using lumen-apposing stents has been described. The procedure was associated with a technical success rate of around 90% and clinical success of 85% to 100%. The procedure holds the potential to create a gastrojejunostomy without surgery. Furthermore, there is a low risk of tumor ingrowth and stent migration, thus improving the stent patency and reducing the need of re-intervention. We have previously published a novel method of creating EUS-GJ with the use of a double balloon occluder (EPASS). The device provides a stable condition for performance of EUS-GJ and improves the safety of the procedure. However, there is limited data on how EPASS compares to endoscopic stenting. The aim of the current study is thus to compare EPASS and DS under a randomized setting.