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

Conditions

• Gastric Outlet Obstruction

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Surgical gastrojejunostomy (SGJ) — PROCEDURE
  Laparoscopic gastrojejunostomy
• Endoscopic gastrojejunostomy (EGJ) — PROCEDURE
  Endoscopic ultrasound (EUS) guided gastrojejunostomy

Study Details

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

Key Dates

Start date

Oct 28, 2022

Status verified

Jun 2026

Primary completion

Dec 31, 2026

Completion

Jun 30, 2027

Study Design

Enrollment

32 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Time to initiation of solid oral intake without symptoms of GOO [ Time Frame: 1 year ]

Central Contacts

• Sumbul Yousafi
  (718) 470-7983
  [email protected]

Locations (4)

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