A clinical study to assess the efficacy of a newer variety of an endoscopic device for diagnosing bile duct cancer

Not Applicable

Conditions: Health Condition 1: null- Patients presenting to the gastroenterology department with features of cholestatic jaundice and clinical diagnosis of cholangiocarcinoma or stricture in common bile duct.

Registration Number: CTRI/2015/11/006332

Lead Sponsor: Andhra Medical College

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 52

Inclusion Criteria

1.Biochemical evidence of cholestasis

a.Increase of Alkaline Phosphatase greater than three times the upper normal limit

And / or

b.Serum direct bilirubin greater than 2.0 mg per dl

2.Extra hepatic bile duct stricture without discrete mass on Computer Tomography (CT) or Magnetic Resonance Imaging (MRI)or Magnetic resonance Cholangio Pancreatography (MRCP).

AND

3.Documented extra hepatic biliary stricture during the Endoscopic Retrograde Cholangio Pancreatography (ERCP)

Exclusion Criteria

1.Patients unwilling to participate in the trial

2.Inability to undergo standard ERCP (post surgical anatomy, other contraindications for ERCP)

3.No clinical suspicion for malignancy

4.CT or MRI scan showing an associated mass

5.Pregnancy, lactation

6.Children less than 12 yrs of age and adults greater than 90 years of age (both exclusive)

7.Endoscopically visible peri- ampullary tumor

8.Strictures not permitting the passage of guide wire or biliary brush

9.Previous brushing or placement of biliary stent.

10.Co- morbid conditons like chronic pancreatitis, Ampullary neoplasm, Carcinoma pancreas, Carcinoma Gall bladder,Hepatocellular carcinoma, metastatic disease with extrabiliary or unknown primary tumour, benign hepatic masses

11.Any ERCP evidence of bile duct compression

12.Postoperative, traumatic and idiopathic biliary strictures.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To identify the sensitivity and applicability of a newer cytology brush for tissue sampling of biliary strictures. <br/ ><br> <br/ ><br>The sensitivity, specificity, positive predictive value and negative predictive value will be calculated for both the randomized groups. <br/ ><br>Analysis will be done based on percentages, chi square test and other relevant tests of significance. <br/ ><br>Timepoint: Each patient will be followed up after the procedure and at the end of six months after randomization

Secondary Outcome Measures

Name	Time	Method
To compare the percentage of patients diagnosed with malignant biliary stricture between newer and older variety of biliary btushTimepoint: The pathology report after the procedure is performed will be studied for this outcome