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Pyloric Stenosis clinical trials

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NCT ID: NCT05142839 Recruiting - Clinical trials for Malignant Biliary Obstruction

Palliation of Gastric Outflow Obstruction in Case of Concomitant Biliary Obstruction.

B-GOOD
Start date: December 15, 2021
Phase: N/A
Study type: Interventional

EUS-guided drainages has been largely widespread during the last 10 years, even thanks to the advent of dedicated devices, such as lumen apposing metal stents (LAMSs). Above all, EUS-guided choledochoduodenostomy (EUS-CD) is to date considered a valuable option of treatment in case of distal malignant biliary obstruction in case of failure of endoscopic retrograde cholangiopancreatography (ERCP) due to the presence of a gastric or duodenal obstruction, unreachable papilla in case of altered anatomy, infiltrated papilla or failure of deep cannulation of the common bile duct. This modality of drainage demonstrated satisfying results, with high rate both of technical and clinical success with acceptable rate of adverse events. When the distal malignant biliary obstruction is associated to signs and symptoms of gastric outflow obstruction (GOO) due to the presence of a gastric or duodenal stenosis, a concomitant or subsequent palliation of the stenosis may be required. Recently, EUS-guided gastroenterostomy (EUS-GEA) has been introduced for the palliation of GOO, showing good results although technically challenging. To date, endoscopic treatment in case of GOO, enteral stenting and EUS-GEA are possible alternatives. However, available data demonstrated that EUS-GEA seems to be superior to enteral stenting in terms of rate of reinterventions during long-term follow-up, especially when life expectancy is superior to 6 months. However, data are lacking regarding which is the best strategy when GOO is associated to distal malignant biliary obstruction, especially when EUS-CD is performed. This is an hot topic, as it has been supposed that EUS-CD has higher rate of adverse events, especially food impaction, when a duodenal stenosis is present. The aim of our study, therefore, is to perform a retrospective multicenter study collecting all consecutive patients affect by distal malignant biliary obstruction drained using EUS-CD, with associated GOO treated with concomitant or subsequent duodenal stenting or EUS-GEA, in order to evaluate clinical efficacy, long term outcomes and severity of adverse events.

NCT ID: NCT05068622 Recruiting - Clinical trials for Respiratory Complication

Gastric Tube in Pyloric Stenosis

SONPYL
Start date: February 15, 2021
Phase:
Study type: Observational

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.

NCT ID: NCT05041608 Enrolling by invitation - GERD Clinical Trials

Endoscopic Surgery for Gastrointestinal Disorders: A Multicenter Registry Study

Start date: February 17, 2021
Phase:
Study type: Observational

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.

NCT ID: NCT04813055 Recruiting - Clinical trials for Chronic Pancreatitis

Prospective Registry Of Therapeutic EndoscopiC ulTrasound

PROTECT
Start date: December 1, 2020
Phase:
Study type: Observational [Patient Registry]

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.

NCT ID: NCT04810377 Recruiting - Clinical trials for Malignant Gastric Outlet Obstruction

Endoscopic Ultrasound-Guided Gastroenterostomy for Malignant Gastric Outlet Obstruction

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

Malignant gastric outlet obstruction is a very disabling complication of patients with gastric, duodenal, ampullary, pancreatic, or bile duct cancer and worsens their prognosis. Current treatments have reported a similar complication rate and higher mortality in surgically treated patients. Recently, the creation of endoscopic ultrasound-guided gastroenterostomy (EUS) has shown promising results in these patients. The aim of this research is to determine the safety and efficacy of EUS-guided gastro-enterostomy in the treatment of patients with malignant gastric outlet obstruction.

NCT ID: NCT04660695 Completed - Pancreatic Cancer Clinical Trials

Nasobiliary Drain Assisted EUS-guided Gastroenterostomies in Unresectable Malignant Gastric Outlet Obstruction

PENGUIN
Start date: August 15, 2019
Phase:
Study type: Observational [Patient Registry]

Gastric outlet obstruction in malignant disease appears when the tumor affects the gastroduodenal area, precluding the passage of food into the small bowel. This condition severely affects the quality of life. In patients with unresectable tumors, there are various available treatments:a surgical bypass connecting the stomach to the small bowel, placing a stent through the tumor to widen the passage and creating a gastrointestinal bypass with a lumen apposing metal stent. These stents are deployed with an echoendoscope, which allows to identify a small bowel loop and to deploy the stent, connecting the small bowel and the stomach. This is called a EUS-guided gastroenterostomy (EUS-GE). EUS-GE is a rather novel procedure. Various techniques to create EUS-GE have been proposed. In this study, the investigators will retrieve data from the procedure and during the thirty following days from consecutive patients undergoing an EUS-GE. The objectives of the study are: - To perform a detailed step by step description of the nasobiliary drain assisted EUS-GE - To describe the adverse events encountered - To describe the proportion of clinical and technical success - To assess its impact on the patients' quality of life. - To assess the evolution of the oral intake during the first month after the procedure

NCT ID: NCT04496050 Active, not recruiting - Clinical trials for Congenital Heart Disease

Effects of Prostaglandin E1 Treatment on Pyloric Wall in Newborns

EOPTOPWT
Start date: May 6, 2019
Phase:
Study type: Observational [Patient Registry]

Prostaglandin E1 (PGE1) has been used in the medical treatment of ductal dependent critical congenital heart disease in neonates. Apnea/ bradycardia, hypotension, hypokalemia, feeding difficulties, fever, jitteriness are the most important side effects of PGE1. Also gastric outlet has been reported. We aimed to determine effect of PGE1 treatment on pyloric wall thickness in newborn period. In this study, the side effect of increase of pylorus muscle wall thickness will be monitored with weekly ultrasonography. No intervention in the treatment, medical decisions and follow-up of these patients will be made. After reaching the sufficient number of cases (20 cases), increases in the pyloric wall thickness dimensions will be compared with statistical analysis. The number of cases was determined in accordance with the rate of hospitalization in our unit during the determined period (18 months).

NCT ID: NCT04375462 Withdrawn - Clinical trials for Malignant Gastric Outlet Obstruction

AspireAssist for Palliative Venting Gastrostomy in Malignant Bowel Obstruction Patients

Start date: February 1, 2023
Phase: N/A
Study type: Interventional

Individuals with cancer causing an intestinal or stomach obstruction often require gastric drainage to prevent symptoms of nausea, vomiting, and to prevent aspiration. This is often achieved by a nasogastric (NG) tube, although prolonged NG tube use can lead to unwanted side effects like ulcers, bleeding, and they are generally uncomfortable. Gastric drainage through the use of a percutaneously placed endoscopic gastrostomy (PEG) tube has been used in people with cancer since the 1980s. This allows relief of symptoms of malignant bowel obstruction though venting of stomach contents. Decompressive PEG tubes are routinely used in individuals with malignant obstruction, although these tubes tend to get clogged from food blocking the tube. The AspireAssist is a weight loss device that allows participants to remove a large amount of the food in their stomachs after each meal to help them to lose weight via an aspiration device attached to the abdominal portion of the tube which allows instillation of water into the stomach, followed by aspiration of the gastric contents into a receptacle or the toilet. The device is placed endoscopically in an identical fashion to a standard PEG tube. Although most commonly used for weight loss, the device is FDA cleared to be used as a venting tube as well. The purpose of this study is to determine if the AspireAssist provides an improved quality of life when compared with a standard venting gastrostomy tube for participants with malignant bowel obstructions.

NCT ID: NCT04148040 Recruiting - Pyloromyotomy Clinical Trials

Per-oral Pyloromyotomy for Treating Infantile Hypertrophic Pyloric Stenosis

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

Infantile hypertrophic pyloric stenosis (IHPS) is the most common condition for surgical treatment in infant. Traditionally, laparoscopic or open pyloromyotomy are the standard treatments. However, because of severe dehydration, electrolyte disturbance, and malnutrition, these patients have lower tolerance about surgery and recover more slowly than usual. We are going to study the per-oral pyloromyotomy (POP), also named as gastric per-oral endoscopic myotomy (G-POEM), which showed promising results for adult gastroparesis, for a novel application of treating IHPS.

NCT ID: NCT03823690 Completed - Clinical trials for Gastric Outlet Obstruction

EPASS Versus Uncovered Duodenal Stent for Unresectable Malignant Gastric Outlet Obstruction.

Start date: February 1, 2020
Phase: N/A
Study type: Interventional

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.