PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Thu, 30 Sep 2021 03:22:03 GMT) CTRI Number CTRI/2015/11/006332 [Registered on: 02/11/2015] - Trial Registered Prospectively Last Modified On 28/10/2015 Post Graduate Thesis No Type of Trial Interventional Type of Study Medical Device Diagnostic Study Design Randomized, Parallel Group, Active Controlled Trial Public Title of Study A clinical study to assess the efficacy of a newer variety of an endoscopic device for diagnosing bile duct cancer Scientific Title of A randomized controlled study to assess diagnostic yield for malignant biliary strictures with newer Study variety of biliary brush Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Palakurthy Murali Krishna Trial Coordinator (multi-center study) Designation Professor and Head, Department of Gastroenterology, Andhra Medical College Affiliation Andhra Medical College Address Department of Gastroenterology, Andhra Medical College, King George Hospital, Maharanipeta, Visakhapatnam-530002, Andhra Pradesh, India Visakhapatnam ANDHRA PRADESH 530002 India Phone 9032032000 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Palakurthy Murali Krishna Query) Designation Professor and Head, Department of Gastroenterology, Andhra Medical College Affiliation Andhra Medical College Address Department of Gastroenterology, Andhra Medical College, King George Hospital, Maharanipeta, Visakhapatnam-530002, Andhra Pradesh, India ANDHRA PRADESH 530002 India Phone 9032032000 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Palakurthy Murali Krishna Designation Professor and Head, Department of Gastroenterology, Andhra Medical College Affiliation Andhra Medical College Address Department of Gastroenterology, Andhra Medical College, King page 1 / 6 PDF of Trial CTRI Website URL - http://ctri.nic.in George Hospital, Maharanipeta, Visakhapatnam-530002, Andhra Pradesh, India ANDHRA PRADESH 530002 India Phone 9032032000 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Department of Gastroenterology, Andhra Medical College, King George Hospital, Maharanipeta, Visakhapatnam 530002, Andhra Pradesh Primary Sponsor Primary Sponsor Details Name Andhra Medical College Address Department of Gastroenterology, Andhra Medical College, King George Hospital, Maharanipeta, Visakhapatnam 530002, Andhra Pradesh Type of Sponsor Government medical college Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Palakurthy Murali Andhra Medical College Department of 9032032000 Krishna Gastroenterology, Andhra Medical muralikrishna63@yaho College, King George o.com Hospital, Maharanipeta, Visakhapatnam 530002, Andhra Pradesh, India Visakhapatnam ANDHRA PRADESH Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institutional Ethics Approved 31/08/2015 No Committee, Andhra Medical College, Visakhapatnam Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Patients presenting to the gastroenterology department with features of cholestatic jaundice and clinical diagnosis of cholangiocarcinoma or stricture in common bile duct. Intervention / Type Name Details Comparator Agent Comparator Agent The wire guided "RX Cytology It measures 2.1 mm X 2.7mm Brush by Boston Scientific". (8 Fr) Intervention 9 Fr wire-guided cytology brush It has a combination of soft and (Infinity sampling device, US stiff bristles for better tissue page 2 / 6 PDF of Trial CTRI Website URL - http://ctri.nic.in Endoscopy). acquisition. Length of brush is 29 mm. Diameter of brush is 4.75 mm Inclusion Criteria Inclusion Criteria Age From 12.00 Year(s) Age To 90.00 Year(s) Gender Both Details 1.Biochemical evidence of cholestasis <br/> a.Increase of Alkaline Phosphatase greater than three times the upper normal limit<br/> And / or<br/> b.Serum direct bilirubin greater than 2.0 mg per dl<br/> <br/> OR<br/> <br/> 2.Extra hepatic bile duct stricture without discrete mass on Computer Tomography (CT) or Magnetic Resonance Imaging (MRI)or Magnetic resonance Cholangio Pancreatography (MRCP).<br/> <br/> AND<br/> <br/> 3.Documented extra hepatic biliary stricture during the Endoscopic Retrograde Cholangio Pancreatography (ERCP)<br/> Exclusion Criteria Exclusion Criteria Details 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. Method of Generating Computer generated randomization Random Sequence Method of An Open list of random numbers Concealment Blinding/Masking Participant and Outcome Assessor Blinded Primary Outcome Outcome Timepoints To identify the sensitivity and applicability of a Each patient will be followed up after the newer cytology brush for tissue sampling of procedure and at the end of six months after biliary strictures. randomization The sensitivity, specificity, positive predictive value and negative predictive value will be page 3 / 6 PDF of Trial CTRI Website URL - http://ctri.nic.in calculated for both the randomized groups. Analysis will be done based on percentages, chi square test and other relevant tests of significance. Secondary Outcome Outcome Timepoints To compare the percentage of patients The pathology report after the procedure is diagnosed with malignant biliary stricture performed will be studied for this outcome between newer and older variety of biliary btush Target Sample Size Total Sample Size=52 Sample Size from India=52 Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials Phase of Trial N/A Date of First 15/11/2015 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=10 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India) Publication Details Brief Summary Biliary strictures are a known association with many neoplastic and inflammatory diseases of the bile duct, pancreas and ampulla.Differentiating the benign from malignant strictures is essential for a proper treatment and follow- up of the patient.Though radiological techniques like ultrasonography, Computer Tomography, Endoscopic Ultrasound and Magnetic Resonance Cholangio Pancreatography (MRCP) can diagnose the strictures, they are not sufficient in differentiating the benign from malignant strictures.Brush cytology has a high specificity , but its drawback is the lower sensitivity rates. New biliary brush models were proposed in order to increase the sensitivity. Some models provided a better diagnostic yield while others did not.There are no published randomized prospective studies comparing the older brush with newer ones (with respect to the newer brushes in market as of 2011). Also, no studies have been proposed in India based on the newer biliary brushes available in the market. The present randomized controlled study will address these issues and will compare the older biliary brush with a newer one. This will be a randomized, participant and outcome assessor blinded, active controlled, prospective study. page 4 / 6 PDF of Trial CTRI Website URL - http://ctri.nic.in Patients with high risk for malignant biliary strictures will be studied. They include patients presenting to the gastroenterology department with features of cholestatic jaundice and clinical diagnosis of cholangiocarcinoma or stricture in common bile duct and those with elevated serum alkaline phosphatase and elevated serum total bilirubin. Biliary brushing in the intervention group will be performed with a newer variety of biliary brush (9 Fr wire-guided cytology brush (Infinity sampling device, US Endoscopy). It has a combination of soft and stiff bristles and hypothesized for better tissue acquisition). Biliary brushing in the comparator group will be performed with wire guided "RX Cytology Brush by Boston Scientific". It measures 2.1 mm X 2.7mm (8 Fr) The study will recruit 52 participants with 26 each in the intervention group and in the comparator group. After obtaining consent from the patient, he/ she will be subjected to Endoscopic Retrograde Cholangio Pancreatography (ERCP). The common bile duct will be visualized under flouroscopy. The presence of stricture in common bile duct will be confirmed.