Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03133026
Other study ID # AIG-001
Secondary ID
Status Recruiting
Phase N/A
First received April 25, 2017
Last updated April 25, 2017
Start date June 2016
Est. completion date July 2018

Study information

Verified date April 2017
Source Asian Institute of Gastroenterology, India
Contact Mohan Ramchandani, MD DM
Phone 9701335444
Email ramchandanimohan@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Primary Objective: To document state-of- the-art multi-modality management of occluded biliary SEMS aiming to minimize number of reinterventions while providing symptom relief without procedure-related serious adverse events.

NOTE: This study will be hypothesis-generating for an anticipated randomized controlled study (RCT) to compare outcomes of placement of a plastic stent inside the occluded SEMS to outcomes of the proposed multi-modality approach.


Description:

Study Design:

Prospective, multi-center, single arm, post market, observational study

Two groups:

- Sludge group: SEMS occluded due to sludge/stones in SEMS

- Ingrowth/overgrowth group: SEMS occluded due to malignant tumor ingrowth or benign hyperplastic tissue overgrowth

Primary Endpoint:

Successful restoration of bile duct drainage with biliary obstructive symptom and cholangitis relief as applicable, without procedure related SAE'S, from procedure through 30 days of follow-up.

Secondary Endpoints:

1. Occurrence and severity of procedure related serious adverse events from procedure through 30 days after procedure

2. Resolution of cholangitis where applicable

3. Technical success of procedure performed for restoration of bile duct drainage, overall and stratified by treatment group Sludge group: Ability to restore stent patency by cleaning the stent content followed by cholangiographically or cholangioscopically confirmed restored stent patency Ingrowth / overgrowth group: Ability to perform biliary radio frequency ablation (RFA) followed by cholangiographically or cholangioscopically confirmed restored stent patency

4. Improvement of biliary obstructive symptoms at 1 week and 1 month post procedure compared to Baseline

5. Improvement of Laboratory Liver Function Tests (LFT) at 1 week and 1 month post procedure compared to Baseline

6. Biliary Reintervention rate from procedure through 30 days after procedure, including reinterventions caused by plastic stent occlusion

7. Impact of cholangioscopy on current standard of care, which is to place a stent inside the occluded SEMS by

- Avoiding placement of a second stent (plastic or metal)

- Avoiding a repeat ERCP

- Reducing associated cost


Recruitment information / eligibility

Status Recruiting
Enrollment 4
Est. completion date July 2018
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- 1. Age 18 or older 2. Willing and able to comply with the study procedures and provide written informed consent to participate in the study 3. Recurrent biliary obstructive symptoms after biliary SEMS placement 4. Biliary SEMS occlusion.

Exclusion Criteria:

- 1. Contraindications for endoscopic techniques 2. Ongoing cholangitis. NOTE: In case a patient presents who meets the inclusion and exclusion criteria, but has cholangitis, then a naso-biliary drain (NBD) will be placed before the ERCP until the cholangitis resolves.

Study Design


Intervention

Device:
Single operator cholangioscopy, Endoscopic biliary RFA
Single operator cholangioscopy will be done to acess the cause of occluded SEMS, if tumour ingrowth or overgrowth seen then endoscopic biliary RFA will be done

Locations

Country Name City State
India Asian Institute of Gastroenterology Hyderabad Telangana

Sponsors (1)

Lead Sponsor Collaborator
Asian Institute of Gastroenterology, India

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Successful restoration of bile duct drainage Successful restoration of bile duct drainage with biliary obstructive symptom and cholangitis relief as applicable, without procedure related SAE'S, from procedure through 30 days followup. 1 month
Secondary Resolution of cholangitis 1. Occurrence and severity of procedure related serious adverse events from procedure through 30 days after procedure 2. Resolution of cholangitis where applicable 4. Improvement of biliary obstructive symptoms at 1 week and 1 month post procedure compared to Baseline 5. Improvement of Laboratory Liver Function Tests (LFTs) at 1 week and 1 month post procedure compared to Baseline 1 week and 1 month
See also
  Status Clinical Trial Phase
Completed NCT02917408 - Retrospective Study About Primary Biliary Cholangitis During January 2001 to July 2016 at West China Hospital
Withdrawn NCT02543957 - Factors Associated With Increased Risk of Bacteremia and Cholangitis in ERCP With Cholangioscopy
Completed NCT02461147 - Prospective Validation of "Cholecystectomy First" Strategy for Gallstone Migration
Completed NCT01824186 - Trial Comparing Pain in Single-incision Laparoscopic Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy N/A
Terminated NCT00990366 - Treatment of Biliary Obstruction Using Biliary Stent With or Without Antireflux Valve N/A
Completed NCT02594891 - Effect of 8.5 F Plastic Stent Without Proximal Flap on Prevention of Post-ERCP Cholangitis N/A
Terminated NCT01142921 - The Patency Period of the New Plastic Anti-reflux Biliary Stent N/A
Completed NCT03104582 - Best Biliary Drainage Option in Advanced Klatskin Tumor N/A
Completed NCT04604652 - Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis Phase 2
Terminated NCT02034279 - The INFECIR-2 Albumin Prevention Study Phase 4
Completed NCT04671095 - Single Use ERCP Performance -SURE Study
Recruiting NCT03087656 - Antibiotics to Decrease Post ERCP Cholangitis Phase 4
Completed NCT02098486 - Comparisons of Intravenous Ceftriaxone With Intravenous Moxifloxacin in ERCP Phase 2
Withdrawn NCT03678480 - A Study of HTD1801 in Adolescents With Primary Sclerosing Cholangitis (PSC) Phase 2
Recruiting NCT04216745 - Microbial Analysis in Patients With Cholangitis
Terminated NCT02618668 - Haemodynamic Stability of Ketamine/Propofol Admixture "Ketofol" in Patient Undergoing Endoscopic Retrograde Cholangio Pancreatography Phase 2
Recruiting NCT01438385 - Interventional Endoscopy Database for Pancreatico-biliary, Gastrointestinal and Esophageal Disorders N/A
Recruiting NCT05750966 - Short-course Antibiotics vs Standard Course Antibiotics in Patients With Cholangitis N/A
Recruiting NCT06111872 - Ketamine-midazolam as a Sedative Agent in Endoscopic Retrograde Cholangiopancreatography. Phase 2
Recruiting NCT05464303 - Definition for Biliary Atresia Associated Cholangitis After Surgery