Comparing endoscopic and surgical methods for treating gastric outlet obstruction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of two different procedures, endoscopic gastrojejunostomy (EGJ) and surgical gastrojejunostomy (SGJ), for treating gastric outlet obstruction (GOO) caused by periampullary malignancies. Patients will be randomly assigned to one of the two treatment groups after providing informed consent. Quality of life will be assessed through questionnaires at various time points before and after the procedures to evaluate their impact on symptoms and overall well-being. The study aims to collect data on adverse events and patient outcomes to determine the best approach for managing GOO.

Why it matters

Who can join: the full rules

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

Where it's running

• Robert Wood Johnson University Hospital
  New Brunswick, New Jersey, United States Recruiting
• North Shore University Hospital
  Manhasset, New York, United States Completed
• Long Island Jewish Medical Center
  New Hyde Park, New York, United States Completed
• Lenox Hill Hospital
  New York, New York, United States Completed

Study contacts

• Principal investigator: Nichol Martinez, MD — Northwell Health
• Study coordinator: Sumbul Yousafi
• Email: syousafi1@northwell.edu
• Phone: (718) 470-7983

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Gastrointestinal Magnet System for Creating a Gastroenterostomy

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• Comparing treatments for malignant gastric outlet obstruction caused by pancreatic cancer

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• Registry analyzing outcomes of therapeutic endoscopic ultrasound procedures

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.