Clinical Trial: Comparison of Duodenal Stenting vs Transpyloric and Duodenal Stenting for Malignant Obstruction

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Comparison of Duodenal Stenting vs Transpyloric and Duodenal Stenting for Malignant Obstruction

Brief Summary: Malignant duodenal obstruction in patients not fit for surgery is treated by placing enteral stents during endoscopy. These patients may also have poor gastric motility. Hence bridging the pyloric opening with the stent along with the duodenal obstruction may deliver better symptomatic improvement. Both approaches are commonly clinically practiced but no formal comparative studies have been done to compare which one is better.

Detailed Summary: Enteral self-expanding metal stents are routinely used to palliate malignant gastric outlet obstruction (pancreas cancer, duodenal cancer, gastric cancer and metastasis) in patients not fit for surgical bypass. The technical success in placing these stents approaches ~100% and many of these procedures can be performed in an outpatient setting. However the functional success (patient's ability to eat) is much lower than the technical success. One of the major reasons for this discrepancy is these patients are on narcotics, which are known to be associated with poor gastric motility. At the discretion of the gastroenterologist, FDA approved enteral stents are placed either completely within the duodenum bridging the obstruction or placed across the pyloric opening besides bridging the duodenal obstruction. The significance of this study is to determine if trans-pyloric extension of an intra-duodenal stent facilitates better gastric emptying compared to an intra-duodenal stent without trans-pyloric extension.
Sponsor: Medical College of Wisconsin

Current Primary Outcome: Change in symptoms from baseline [ Time Frame: 48 hrs after stent deployment and up to 6 months after stent deployment ]

Able to eat with relief of nausea, regurgitation, bloating, or vomiting


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Technical success: Stent placed in the desired position as per randomization [ Time Frame: Day of stent deployment ]
    Successful placement of the stent across the duodenal obstruction with or without trans-pyloric extension as per randomization will determined immediately during endoscopic procedure by endoscopic visualization.
  • Complications [ Time Frame: Up to 6 months after stent deployment ]
    Stent related complications
  • Gastric emptying [ Time Frame: 48 hours after stent placement ]
    Gastric emptying study test


Original Secondary Outcome: Same as current

Information By: Medical College of Wisconsin

Dates:
Date Received: April 14, 2017
Date Started: May 10, 2017
Date Completion: March 19, 2018
Last Updated: April 26, 2017
Last Verified: April 2017