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Gastric Outlet Obstruction clinical trials

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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.

NCT ID: NCT03650842 Completed - Pyloric Stenosis Clinical Trials

Changes in Cerebral Oxygenation During Laparoscopic Pyloromyotomy

Start date: July 7, 2017
Phase: N/A
Study type: Interventional

A prospective study that will assess the effect of laparoscopy on tissue oxygenation in the patients undergoing a laparoscopic pyloromyotomy at Nationwide Children's Hospital. Tissue oxygenation will be assessed non-invasively using near infrared spectroscopy, a device that is commonly used in our operating rooms to assess cerebral and tissue oxygenation.

NCT ID: NCT03259763 Recruiting - Clinical trials for Gastric Outlet Obstruction

EUS-GE vs ES for Palliation of Gastric Outlet Obstruction

Start date: October 26, 2020
Phase: N/A
Study type: Interventional

Gastric outlet obstruction (GOO) is a common complication of luminal malignancies which is associated with substantial morbidity. Palliation of GOO has traditionally been through the surgical bypass of the obstructed lumen by creating an opening between the stomach and small intestine. However, In recent years, a less invasive approach, i.e. endoscopic stenting, has gained wide acceptance to treat unresectable malignant gastric outlet obstruction. In this study, the investigators are going to compare the safety and efficacy of the two different endoscopic techniques including Endoscopic ultrasonography-guided gastroenterostomy (EUS-GE) and enteral stenting (ES).

NCT ID: NCT03223831 Completed - Clinical trials for Unresectable Malignant Gastric Outlet Obstruction

Partially Covered Versus Uncovered Pyloro-duodenal Stents for Unresectable Malignant Gastric Outlet Obstruction. A Double Blinded Randomised Controlled Trial.

Start date: August 1, 2017
Phase: Phase 3
Study type: Interventional

To compare the efficacy of a novel partially covered (PC) versus uncovered (UC) pyloro-duodenal stents (DS) in unresectable malignant gastric outlet obstruction. We hypothesize that the use of PCDS could reduce the re-intervention rates when compared to UCDS.

NCT ID: NCT03223480 Completed - Clinical trials for Gastric Outlet Obstruction

EUS - Guided Balloon-occluded Gastrojejunostomy Bypass

Start date: August 24, 2018
Phase: Phase 2/Phase 3
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 (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.

NCT ID: NCT03095144 Not yet recruiting - General Anesthesia Clinical Trials

Spinal Anesthesia and General Anesthesia for Pyloromyotomy - Surgical Outcomes a Comparison Retrospective Study

Start date: May 2017
Phase: N/A
Study type: Observational

Background: The purpose of this retrospective study is to evaluate surgical outcomes of pyloromyotomy in infants performed under spinal anesthesia compares to general anesthesia. Methods: After receiving the approval of the hospital ethics committee, retrieving, reviewing files and collecting data. Primary outcomes: total operating room time, duration of surgery, pain management and postoperative apnea episodes, time of regaining full enteral feeding. Secondary outcome measures: include cardio-respiratory changes and events, and substantial vomiting postoperatively.

NCT ID: NCT02775214 Terminated - Pyloric Stenosis Clinical Trials

Conventional Direct Laryngoscopy Vs. Video Laryngoscopy With The C-MAC For Pyloromyotomy

Start date: September 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to compare two different ways of placing breathing tubes for surgery. Both ways are used currently to place breathing tubes and are safe and effective. This study seeks to determine if one way is better than the other for infants with pyloric stenosis.

NCT ID: NCT02440724 Recruiting - Clinical trials for Malignant Gastric Outlet Obstruction

The Usefulness of Self-expandable Metal Stents(SEMS) for Malignant Gastric Outlet Obstruction: a Prospective Study Using New Designed Stents

SEMS
Start date: August 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate usefulness of new designed winged stent(SEMS).

NCT ID: NCT02376907 Active, not recruiting - Jaundice Clinical Trials

Biliary Drainage in Patients With Duodenal Metal Stent

Start date: January 2010
Phase: N/A
Study type: Observational

This is a retrospective study to evaluate the outcomes of endoscopic biliary drainage according to the timing of distal malignant biliary obstruction (MBO) in relation to gastric outlet obstruction (GOO) and the location of GOO.

NCT ID: NCT02359305 Completed - Pyloric Stenosis Clinical Trials

Institutional Audit of the Use of Intravenous Acetaminophen in Infants Undergoing Pyloromyotomy

Start date: June 2014
Phase: N/A
Study type: Observational

This is a retrospective chart review. The objective of the current study is to determine the analgesic efficacy and side effect profile of intravenous acetaminophen when administered to infants undergoing pyloromyotomy. In addition, recovery characteristics of infants who were administered intravenous acetaminophen will be compared to infants who did not receive intravenous acetaminophen to determine if there were any appreciable differences with regard to postoperative discomfort, PACU time, time to oral feeds and hospital discharge.