Enteral Anastomosis for the Treatment of Gastric Outlet Obstruction: A Randomized Controlled Study Comparing Endoscopic Versus Surgical Gastrojejunostomy

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Gastric outlet obstruction (GOO) occurs commonly in malignancies involving the periampullary region (cancers originating in the head of the pancreas, duodenum, bile duct, or ampulla) or the distal stomach. GOO not only causes debilitating symptoms such as nausea, vomiting, inability to tolerate oral intake, and prevents adequate nutritional intake. Therefore, providing therapy for GOO is imperative to improve the quality of life, and nutritional status of these patients, as well as allow them to continue receiving their cancer treatment

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Periampullary malignancy (pancreas, bile duct, ampulla, duodenum) extending to the distal duodenum (D3) or distal (antrum) gastric cancer

• Symptoms of gastric outlet obstruction (at least 2 of 4 required):

‣ post prandial vomiting,

⁃ abdominal pain,

⁃ inability to tolerate PO,

⁃ imaging consistent with GOO

• Gastric Outlet Obstruction Scoring System (GOOSS) Score of 0 (no oral intake) or 1 (liquids only)

• Age \>18 years old

• Life expectancy greater than 2 months or failed duodenal stenting

• Surgical Candidate/Tolerate General Anesthesia

• Unresectable or metastatic disease

Locations
United States
New York
North Shore University Hospital
RECRUITING
Manhasset
Long Island Jewish Medical Center
RECRUITING
New Hyde Park
Lenox Hill Hospital
RECRUITING
New York
Contact Information
Primary
Molly Stewart
mstewart8@northwell.edu
718-470-4667
Backup
Hye Jeong Jang
hjang3@northwell.edu
718-470-7983
Time Frame
Start Date: 2022-10-28
Estimated Completion Date: 2025-06
Participants
Target number of participants: 32
Treatments
Active_comparator: Surgical gastrojejunostomy (SGJ)
An anastomosis will be created between the stomach and the proximal loop of the jejunum during a laparoscopic surgical procedure.
Experimental: Endoscopic gastrojejunostomy (EGJ)
A stent is placed between the stomach and adjacent small intestine under endoscopic ultrasound guidance during an upper endoscopic procedure.
Related Therapeutic Areas
Sponsors
Leads: Northwell Health

This content was sourced from clinicaltrials.gov

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