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Compares treatment options for Gastric Outlet Obstruction
Official title Enteral Anastomosis for the Treatment of Gastric Outlet Obstruction: A Randomized Controlled Study Comparing Endoscopic Versus Surgical Gastrojejunostomy
ClinicalTrials.gov ID: NCT05561907
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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,
You likely can't join if
- Age\< 18 years old
- Pregnancy
- Intestinal obstruction distal to the Ligament of Treitz
- Evidence of other luminal strictures of the GI tract
- Previous gastric or periampullary surgery
- Inability to complete quality of life surveys (QOLS)
See the full eligibility criteria
- 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
- Age\< 18 years old
- Pregnancy
- Intestinal obstruction distal to the Ligament of Treitz
- Evidence of other luminal strictures of the GI tract
- Previous gastric or periampullary surgery
- Inability to complete quality of life surveys (QOLS)
- Presence of abdominal ascites
The study team makes the final eligibility decision.
Where it's taking place
- New Brunswick, New Jersey, United States
- Manhasset, New York, United States
- New Hyde Park, New York, United States
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Brunswick, New Jersey, United States; Manhasset, New York, United States; New Hyde Park, New York, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.