Bile Duct Neoplasms Malignant Clinical Trial
Official title:
Endoscopic Palliation of Malignant Biliary Tract Obstruction: Emphasis on Improvement in Quality of Life
Endoscopic stent insertion is considered the method of choice for palliation of malignant bile duct obstruction (MBDO). However, it can cause complications and requires periodic stent exchanges. While endoscopic stenting is clearly indicated for relief of cholangitis or refractory pruritus, its role in patients with jaundice alone is less clear. Endoscopic stenting for this relative indication might be justified, if there is a significant improvement in quality of life (QOL) of such patients. The aim of the investigators study was to determine whether endoscopic stenting for MBDO results in improved QOL.
Most malignant tumors causing bile duct obstruction, such as pancreatic adenocarcinoma,
gallbladder carcinoma or cholangiocarcinoma, have an extremely poor prognosis. At the time
of diagnosis the majority of these tumors will be unresectable with a median survival of 4-6
months. Palliation is the goal for those patients with unresectable tumors and limited
survival and for those at high risk for attempts at curative resection.
Endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic stent insertion is
considered the method of choice for palliative treatment of malignant bile duct obstruction
(MBDO). However, it can cause complications, such as pancreatitis, bleeding, perforation,
cholangitis and stent migration in a significant proportion of treated patients. Clogging of
plastic stents is a predictable consequence and requires periodic stent exchanges with
attendant risks and costs. While endoscopic stenting is clearly indicated for relief of
cholangitis or refractory pruritus, the role of stenting in patients with jaundice alone,
abdominal pain, or failure to thrive due to malignancy is less clear. Given the risk for
complications and costs, endoscopic therapy might be justified in these clinical scenarios
if quality of life (QOL) is significantly improved. A few available studies have
demonstrated improved QOL in stented patients. However, these studies include a small number
of patients and/or are retrospective in design. Therefore, more evidence to support routine
palliative biliary drainage in patients with MBDO is desired.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
NCT03951324 -
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