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| Name | Class |
|---|---|
| American Society for Gastrointestinal Endoscopy | OTHER |
| American College of Gastroenterology | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10 French Stent | Active Comparator | 10 French biliary plastic stent |
|
| 11.5 French stent | Active Comparator | 11.5 French biliary plastic stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ERCP with 10 French biliary plastic stent placement | Procedure | Stent placement of a 10 French biliary plastic stent |
|
| Measure | Description | Time Frame |
|---|---|---|
| Documented change in Quality Of Life | Documented change in QOL over the first month and over six months after successful biliary drainage compared with that before the procedure. The FACT-G questionnaire administered at baseline, at 1 month after stent insertion and at 180 days after stent insertion was used to assess this outcome. Change from baseline was analyzed at each of these time points separately. | 180 days after stent insertion |
| Measure | Description | Time Frame |
|---|---|---|
| Documented change in symptoms and concerns specific for patients with MBDO | An additional 10 item questionnaire was administered at baseline, at 1 month after biliary stenting and at 180 days after biliary stenting. | 180 days after stent placement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart Sherman, MD | Indiana University Medical Center | Principal Investigator |
| Glen A Lehman, MD | Indiana Univesity Medical Center | Principal Investigator |
| James Frankes, MD | Rockford GE Associates | Principal Investigator |
| John Johanson, MD | Rockford GE Associates | Principal Investigator |
| Tahir Qaseem, MD | MaineHealth | Principal Investigator |
| Douglas Howell, MD | MaineHealth | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11814064 | Background | Jemal A, Thomas A, Murray T, Thun M. Cancer statistics, 2002. CA Cancer J Clin. 2002 Jan-Feb;52(1):23-47. doi: 10.3322/canjclin.52.1.23. | |
| 14761910 | Background | Lowy AM. From bad to worse: prognostic factors in pancreatic cancer. Ann Surg Oncol. 2004 Feb;11(2):117-8. doi: 10.1245/aso.2004.12.930. No abstract available. |
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| ID | Term |
|---|---|
| D007565 | Jaundice |
| ID | Term |
|---|---|
| D006932 | Hyperbilirubinemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
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| ID | Term |
|---|---|
| D002760 | Cholangiopancreatography, Endoscopic Retrograde |
| ID | Term |
|---|---|
| D002758 | Cholangiography |
| D011860 | Radiography, Abdominal |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
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| ERCP with 11.5 French biliary plastic stent | Procedure | biliary plastic stent placement |
|
| Background | Lowenfels AB, Maisonneuve P, Boyle P (1998) Epidemiology of pancreatic cancer. In: Howard J, Idezuki Y, Ihse I, Prinz R, eds. Surgical Diseases of the Pancreas. 3rd ed. Baltimore: Williams & Wilkins, 433-439 |
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| D012816 | Signs and Symptoms |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003938 | Diagnostic Techniques, Digestive System |
| D016145 | Endoscopy, Digestive System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |