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A Randomized Controlled Trial of Endoscopic Biliary Radiofrequency Ablation of Malignant Distal Common Bile Duct Strictures.


Phase 2/Phase 3
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer, Cholangiocarcinoma

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Trial Information

A Randomized Controlled Trial of Endoscopic Biliary Radiofrequency Ablation of Malignant Distal Common Bile Duct Strictures.


Inclusion Criteria:



1. Age ≥ 18 years old with informed consent

2. Histologically (preferred) or radiologically confirmed distal malignant bile duct
tumors

3. Inoperability by staging, comorbidities or patient wishes

4. Distal tumors 2cm away from the portal hilum

5. Bilirubin > 50umol/L at diagnosis

Exclusion Criteria:

1. Periampullary tumours

2. Multiple hepatic metastases with significant blockage of one or more liver segments
(if no segment blockage, metastasis is not an exclusion criteria)

3. Presence of main portal vein thrombosis

4. Prior SEMS placement

5. Prior Billroth II or roux-en Y reconstruction

6. History of bleeding disorder or use of anticoagulation

7. Child's B/C cirrhosis

8. Pregnancy

9. Performance status ECOG ≥3 (confined to bed / chair > 50% waking hours)

10. Presence of other malignancy

11. Presence of gastric outlet obstruction

12. Life expectancy < 3months

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Stent patency rate

Outcome Time Frame:

6 months

Safety Issue:

No

Authority:

Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Study ID:

CRE 2012.153

NCT ID:

NCT01721174

Start Date:

November 2012

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • Cholangiocarcinoma
  • Pancreatic cancer
  • Cholangiocarcinoma
  • Endoscopic radiofrequency ablation
  • Pancreatic Neoplasms
  • Cholangiocarcinoma
  • Cholestasis
  • Constriction, Pathologic

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