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Celecoxib for Prevention of Progression in Peutz-Jeghers Syndrome

RecruitingNAAges 8 Years - anyAllAir Force Military Medical University, China
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In plain words

What the trial is, and whether it could suit you

The Peutz-Jeghers Syndrome (PJS) is a rare autosomal dominant syndrome characterized by mucocutaneous pigmentations, multiple gastrointestinal hamartomatous polyps, and an elevated risk of developing malignancies. Patients with PJS often experience recurrent gastrointestinal polyps that gradually increase in number and size, requiring repeated treatments. As the disease progresses, most patients are forced to undergo multiple surgical or endoscopic treatments. Small bowel polyps develop in 60-90% of patients with PJS, and intussusception occurs in 65% of these patients. Currently, on-demand surgery or scheduled endoscopic polypectomy is the standard of care for the management of small bowel polyps, and among patients who have undergone an initial surgery, reoperation is performed in up to 40% within 5 years. In addition, 8-40% of patients develop small bowel polyp-related complications e

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: \- Patients with PJS โ‰ฅ 8 years of age Diagnostic criteria for PJS: meeting any of the following criteria or presence of an STK11 gene variant: 1. Two or more histologically confirmed PJS hamartomatous polyps; 2. Any number of PJS polyps detected in an individual with a family history of PJS in close relative(s); 3. Characteristic mucocutaneous pigmentation in an individual with a family history of PJS in close relative(s); 4. Any number of PJS polyps in an individual with characteristic mucocutaneous pigmentation. Exclusion Criteria: 1. Allergy to NSAIDs; 2. Long-term use of any dose of NSAIDs, including aspirin or celecoxib, within 6 months prior to enrollment (willing to undergo a 3-month washout period to restore eligibility); 3. Imaging indicate small intestinal polyps โ‰ฅ 3 cm in diameter, intestinal intussusception, intestinal obstruction or intestinal tumor at the time of enrollment; 4. Surgical treatment for small intestinal polyps within 2 years prior to enrollment; 5. Anticipated small bowel resection due to severe polyps within 6 months of enrollment; 6. Receiving other medications for gastrointestinal polyps; 7. Peptic ulcer within 3 months prior to enrollment; 8. Unstable cardiorespiratory condition; 9. Serious renal, hepatic or haematological dysfunction (creatinine \>1.5 ร— ULN; ALT \>1.5 ร— ULN, AST \>1.5 ร— ULN, ALP \>1.5 ร— ULN, TBIL \>2 ร— ULN; haemoglobin \<10 g/dL, platelet count \<100,000/mL, white blood cells \<3000/mL) or other systemic diseases are unsuitable for participation in this study; 10. Pregnancy or breastfeeding; 11. Unwilling or unable to sign the informed consent form
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What it tests

  • Celecoxib 400mg
  • Placebo
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Where

1 site
Xijing Hospital of Digestive Diseases, Air Force Military Medical University
Xi'an, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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