Recruiting

Endoscopic vs. Surgical

Sponsor:

Northwell Health

Code:

NCT05561907

Conditions

Gastric Outlet Obstruction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Surgical gastrojejunostomy (SGJ)

Endoscopic gastrojejunostomy (EGJ)

Study Details

Brief 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

Conditions

Gastric Outlet Obstruction

Study ID

NCT05561907

Start date

Oct 28, 2022

Status verified date

Jun, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Periampullary malignancy (pancreas, bile duct, ampulla, duodenum) extending to the distal duodenum (D3) or distal (antrum) gastric cancer
2. Symptoms of gastric outlet obstruction (at least 2 of 4 required):

1. post prandial vomiting,
2. abdominal pain,
3. inability to tolerate PO,
4. imaging consistent with GOO
3. Gastric Outlet Obstruction Scoring System (GOOSS) Score of 0 (no oral intake) or 1 (liquids only)
4. Age >18 years old
5. Life expectancy greater than 2 months or failed duodenal stenting
6. Surgical Candidate/Tolerate General Anesthesia
7. Unresectable or metastatic disease

Exclusion Criteria:

1. Age< 18 years old
2. Pregnancy
3. Intestinal obstruction distal to the Ligament of Treitz
4. Evidence of other luminal strictures of the GI tract
5. Previous gastric or periampullary surgery
6. Inability to complete quality of life surveys (QOLS)
7. Presence of abdominal ascites

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Surgical gastrojejunostomy (SGJ)

Laparoscopic gastrojejunostomy

Endoscopic gastrojejunostomy (EGJ)

Endoscopic ultrasound (EUS) guided gastrojejunostomy

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Sumbul Yousafi

(718) 470-7983syousafi1@northwell.edu

Locations

Robert Wood Johnson University Hospital

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Molly Stewart

(732) 235-3247molly.stewart1@rutgers.edu

Principal Investigator:

Petros Benias, MD

More Information

Sponsor

Northwell Health

Last update posted

Jun 15, 2026

Last verified

Jun, 2026

Keywords

  • Gastric outlet obstruction
  • GOO
  • Periampullary malignancy
  • Periampullary cancer
  • Surgical gastrojejunostomy
  • Endoscopic gastrojejunostomy
  • Gastrojejunostomy
  • Enteral anastamosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2026-06-15.