EPASS Versus Uncovered Duodenal Stent for Unresectable Malignant Gastric Outlet Obstruction.
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|ClinicalTrials.gov Identifier: NCT03823690|
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : March 14, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Gastric Outlet Obstruction||Device: EUS-guided gastrojejunstomy Device: The pyloro-duodenal stent||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||92 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The patients would be randomized to either EUS-guided balloon-occluded gastrojejunostomy bypass (EPASS) or uncovered duodenal stent after cannulation of the obstruction site is achieved with the guide-wire.|
|Masking Description:||Recruited patients would not be informed of the type of treatment that was received.|
|Official Title:||EUS-guided Balloon-occluded Gastrojejunostomy Bypass (EPASS) Versus Uncovered Duodenal Stent for Unresectable Malignant Gastric Outlet Obstruction.|
|Actual Study Start Date :||February 1, 2020|
|Estimated Primary Completion Date :||June 30, 2023|
|Estimated Study Completion Date :||June 30, 2023|
Active Comparator: EUS-guided gastrojejunostomy
The procedures would be performed under conscious sedation or monitored anesthesia by a therapeutic gastroscope. The endoscope would be used to reach the site of obstruction. The stricture would be cannulated with a 0.025" or 0.035" guide-wire. The double balloon occluder would then be inserted on guidewire beyond the duodenal-jejunal flexure and the two balloons of the occluder would be inflated.
A segment of duodenum/jejunum would then be occluded and saline would be injected. A linear echoendoscope would then be inserted into the stomach to guide insertion of the gastrojejunostomy stent.
Device: EUS-guided gastrojejunstomy
As listed in the arms description
Other Name: EPASS
Active Comparator: Pyloro-duodenal stent
The uncovered DS used in this study is Wallflex (Boston, Natick, MA, USA), made of nitinol wire, with a diameter of 22mm and length of 6, 9, 12cm. This stent is a braided stent with high axial force, good flexibility and conformability.
Device: The pyloro-duodenal stent
As listed in the arms description
Other Name: DS
- Re-intervention rate [ Time Frame: 6 months ]The percentage of patients requiring additional endoscopic intervention due to stent dysfunction.
- Technical success rate [ Time Frame: 1 day ]The successful placement of a stent across the site of obstruction, as confirmed by endoscopy or fluoroscopy.
- Clinical success rate [ Time Frame: 3 days ]Clinical success if measured by the improvement of at least 1 point in the gastric outlet obstruction score within 3 days after stent insertion.
- Stent dysfunction rate [ Time Frame: 6 months ]Stent dysfunction is defined as the restenosis of the stent due to tumor ingrowth or overgrowth, stent migration, or fracture.
- Duration of stent patency [ Time Frame: 6 months ]Calculated from the time of stent placement to the time of stent dysfunction.
- Adverse events rate [ Time Frame: 6 months ]Graded according to the lexicon of endoscopic adverse events
- Mortality [ Time Frame: 6 months ]Death from any cause
- Gastric outlet obstruction scores (GOOS) [ Time Frame: 6 months ]Scoring system for food intake. Range of score is 0 -3 with 3 being the highest and indicating tolerating full diet
- Quality of life assessment scores [ Time Frame: 6 months ]EORTC QLQ-C30. This questionnaire is designed to measure cancer patients' physical, psychological and social functions. The questionnaire is composed of 5 multiitem scales (physical, role, social, emotional and cognitive functioning) and 9 single items (pain, fatigue, financial impact, appetite loss, nausea/vomiting, diarrhea, constipation, sleep disturbance and quality of life). All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
- Quality of life assessment scores [ Time Frame: 6 months ]EORTC STO-22 modules. This the gastric cancer module to the QLQ-C30 questionnaire. The questionnaire is composed of 5 multiitem scales (dysphagia, pain, reflux, eating, anxiety) and 4 single items. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03823690
|Contact: Anthony Y Teoh, FRCSEdfirstname.lastname@example.org|
|Contact: Man Yee Yung, BScemail@example.com|
|Department of Surgery, Prince of Wales Hospital||Recruiting|
|Hong Kong, Hong Kong|
|Contact: Anthony YB Teoh, FRCSEd(Gen) 85235052953 firstname.lastname@example.org|
|Principal Investigator: Anthony YB Teoh|