NCT05561907 Enteral Anastomosis for the Treatment of Gastric Outlet Obstruction: A Randomized Controlled Study Comparing Endoscopic Versus Surgical Gastrojejunostomy
| NCT ID | NCT05561907 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northwell Health |
| Condition | Gastric Outlet Obstruction |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2022-10-28 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 32 participants in total. It began in 2022-10-28 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Contact & Investigator
Nichol Martinez, MD
PRINCIPAL INVESTIGATOR
Northwell Health
Frequently Asked Questions
Who can join the NCT05561907 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastric Outlet Obstruction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05561907 currently recruiting?
Yes, NCT05561907 is actively recruiting participants. Contact the research team at syousafi1@northwell.edu for enrollment information.
Where is the NCT05561907 trial being conducted?
This trial is being conducted at New Brunswick, United States, Manhasset, United States, New Hyde Park, United States, New York, United States.
Who is sponsoring the NCT05561907 clinical trial?
NCT05561907 is sponsored by Northwell Health. The principal investigator is Nichol Martinez, MD at Northwell Health. The trial plans to enroll 32 participants.