Status:
WITHDRAWN
Retreatment and Its Efficiency of Thalidomide for Vascular Malformation Patients With Failure of First Course Treatment
Lead Sponsor:
Zhizheng Ge
Conditions:
Gastrointestinal Bleeding of Unknown Origin
Gastrointestinal Vascular Malformation
Eligibility:
All Genders
35-85 years
Phase:
PHASE2
Brief Summary
Background: Repeated episodes of bleeding from gastrointestinal vascular malformations refractory to endoscopic or surgical therapy often pose a major therapeutic challenge. Methods: The investigator...
Detailed Description
Protocol Description: This is an exploratory, randomized, double blind, placebo controlled study of thalidomide for retreatment patients with failure of first course thalidomide treatment for recurre...
Eligibility Criteria
Inclusion
- Age between 35-85 years; women are post-menopausal, post-tubal ligation, or on some form of birth control like long-term laying up contraceptive ring or using condom;
- Patients with failure of first course treatment of thalidomide, which means rebleeds decreased from baseline by\< 50% at 12 months follow up ;
- History of at least six documented gastrointestinal bleeding episodes in the year prior first course thalidomide treatment, which are refractory or inaccessible to endoscopic therapy or surgical ectomy; so, patients should have at least four episodes of gastrointestinal bleeding a year prior our study;
- Confirmed diagnosis of vascular malformation by esophagogastroduodenoscopy (EGD), capsule endoscope (CE), double-balloon endoscope (DBE), or colonoscopy, but no obvious infectious, neoplastic, or other specific diagnosis;
- Angiodysplasia at endoscopy characterized by focal or diffused venous/capillary lesions presenting as bright red ectatic vessels or pulsatile red protrusions, with surrounding venous dilatation or patchy erythema with or without oozing;
- Endoscopic appearance of GAVE (also known as watermelon stomach), indicated by longitudinal antral folds converging on the pylorus, containing visible columns of tortuous red ecstatic vessels.
Exclusion
- Patients are excluded if first course treatment of thalidomide is effective, which means rebleeds decreased from baseline by ≥ 50% at 12 months follow up;
- if they have cirrhotic or portal hypertension gastropathy; severe co-morbidities of cardiac, pulmonary, renal, liver, hematological, rheumatologic disorders, or uncontrollable diabetes mellitus or hypertension;
- if they have a history of severe bilateral peripheral neuropathy or seizure activity, thromboembolic disease, known thalidomide allergy;
- if they have a history of treatment with any dose of systemic or oral topical corticosteroids or aspirin, NSAIDs, anti-platelet drugs, anticoagulants, or Chinese medications (with salicylates), gingko, or Echinacea, or other putative immunomodulators or anti-angiogenic agents;
- Currently pregnant or lactating or currently undergoing systemic cancer chemotherapy or receiving radiation
Key Trial Info
Start Date :
December 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02301949
Start Date
December 1 2015
End Date
December 1 2018
Last Update
April 21 2016
Active Locations (1)
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1
Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200127