Role of Endoscopic RFA in Prolonging the Patency of Metal Stents in Patients With Malignant Obstr… (NCT01275768) | Clinical Trial Compass
UnknownPhase 1/2
Role of Endoscopic RFA in Prolonging the Patency of Metal Stents in Patients With Malignant Obstructive Jaundice
India100 participantsStarted 2011-01
Plain-language summary
Patients with malignant obstructive jaundice (cancer of head of pancreas and cholangiocarcinoma) generally have a very poor prognosis with less than 20% patients having resectable disease at presentation. These patients also have a very poor quality of life with a life expectancy of 6-8 months. Jaundice associated with pruritus, poor appetite, malabsorption and loss of weight and cholangitis is the most common and troublesome problem. Placement of metallic stents has been the standard of care for patients with unresectable disease. However, about 50% of these stents get blocked in 6-8 months. Use of endoscopic Radio-frequency Ablation (RFA) prior to placement of metal stents may increase the patency of these stents
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients: Clinical data and investigations suggestive of unresectable malignant bile duct obstruction. All patients will be discussed at the hepato-biliary multidisciplinary meeting which should come to a unanimous decision on tumor unresectability.
✓. Informed consent: The patient should voluntarily agree to participation and randomization. Oral and written information about the nature of the trial will be given to all patients considered for inclusion.
Exclusion criteria
✕. Informed consent not obtained or withdrawn
✕. Extremely poor general condition not amenable for conscious sedation used for ERC
✕. Candidate suitable for surgical resection
✕. Klatskin type 4 tumor
✕. Previous biliary intervention such as plastic stent insertion for more than 1 month