Bile Duct NeoplasmsMBOPNCT05320328
RADIO FREQUENCY ABLATION IN UNRESECTABLE MALIGNANT BILIARY OBSTRUCTION
An observational study of Bile Duct Neoplasms and Gall Bladder Carcinoma, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial summary
Endoscopic retrograde cholangio pancreatography procedure will performed as per local standard procedure.After common bile duct cannulation,cholangiography will be performed (to confirm the stricture) followed by biliary sphincterotomy. All biliary strictures(Bismuth Type I/II/III/IV) will be enrolled for the study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bile Duct Neoplasms, Gall Bladder Carcinoma
- What is being tested?
- Radio frequency ablation
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 10 Jun 2021to 10 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: 50 Subjects
Who may be able to join
- Age 18-75 years
- Malignant biliary obstruction confirmed using computed tomography (CT) or abdominal magnetic resonance imaging(MRI), with pathological confirmation whenever possible;
- Clinical jaundice, a serum bilirubin level greater than 5 mg/dL, and/or cholangitis;
- ECOG performance status score≤2
- Un resectability or refusal to be surgically treated.
- Eligible patients were those with biliary obstruction due to cancer of the gallbladder, or bile ducts; who were considered unsuitable for surgery because of distant metastases, vascular invasion, or severe disability due to age or associated diseases.
- Non-resectability was established through the consensus opinion of a multidisciplinary tumor board.
- Written informed consent signed by the patient.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Asian Institute of Gastroenterology
Hyderabad, Telangana, 500082
Rajesh Goud, M.Pharma MBA, 23378888 ext. 040, rajeshgoud761@gmail.com
About this study
Official title: SAFETY AND EFFICACY OF INTRA DUCTAL RADIO FREQUENCY ABLATION IN UNRESECTABLE MALIGNANT BILIARY OBSTRUCTION: PROSPECTIVE OBSERVATIONAL STUDY
Endoscopic retrograde cholangio pancreatography procedure will performed as per local standard procedure.After common bile duct cannulation,cholangiography will be performed (to confirm the stricture) followed by biliary sphincterotomy. All biliary strictures(Bismuth Type I/II/III/IV) will be enrolled for the study.
Patient opting for Uncovered self expandable metallic stent / Plastic stent will undergo biliary stent placement and considered under control arm Patient opting for radio frequency ablation + Uncovered SEMS/Plastic stent will undergo radio frequency ablation and biliary stent placement and considered under Study arm The RFA probe will be inserted into the bile duct alongwith the guidewire. Keeping the electrode overlapping the stricture, RFA will be performed using a power of 10W for 120 seconds. The electrode will be kept at the ablation site for an additional 1 minute to allow the RFA probe to cool before removal to prevent thermal injury of normal tissue and/or endoscope accessory channel. If the stricture is more than 3 cm, step-by-step RFA will be performed from the superior to inferior aspect. After RFA application, an uncovered SEMS/Plastic stent will be placed.
Read the detailed description
Placement of self expandable metallic stent is the standard of care in the palliative management of patients with malignant biliary strictures . Relieves biliary obstruction and jaundice.
Self expandable metallic stent provide efficient drainage and have superior patency rates compared with the plastic stents Endoscopic radio frequency ablation combined with stent placement can significantly prolong survival and the stent patency period without increasing the incidence of adverse events in patients with extra hepatic cholangiocarcinoma patient.
Compared to plastic/ metal stent placement alone the addition of radio frequency ablation to stent placement would have better outcomes.
- Conditions
- Bile Duct Neoplasms, Gall Bladder Carcinoma
- Being tested
- Radio frequency ablation
- Medical subject headings
- Bile Duct Neoplasms, Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radio frequency ablationDevice
Also called RFA
Radiofrequency ablation (RFA) uses heat to kill cancer cells. High-frequency electrical currents are passed through a special needle or probe called a needle electrode. The electrical current from the probe heats a small area containing cancer cells to high temperatures, killing the cancer cells. The area around the tumour is also usually treated because it may contain cancer cells.
| Study group | Role | What they receive |
|---|---|---|
| 1 | The study group (A) will receive radio frequency ablation followed by uncovered Self expandable metal stent/Plastic stent placement (one or more)at same procedure. Receives: Device: Radio frequency ablation | |
| 2 | The control group (B) will receive uncovered Self expandable metal stent / Plastic stent (one or more) placement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prospectively evaluate the safety and efficacy of combining intraductal Radio frequency ablation with biliary metal/ plastic stent placement for patients with malignant biliary obstruction.
satety of radio frequency ablation assessed by complications/adverse effects post procedure and efficacy of the procedure will be assessed by stent patency at the end of one month
Measured: 12 months
Secondary outcomes (1)
Stent patency at 1 year
Stent patency will be estimated by bio chemical parameters (Total bilirubin, Alkaline phosphatase) or ultra sound abdomen scan
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start10 Jun 2021
- Primary completion10 Jun 2022 (estimated)
- Study completion10 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bile Duct NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Ramchandani, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05320328
- Sponsor's protocol ID
- RFA
- Acronym
- MBOP
- Status last verified
- Apr 2022
- First submitted
- 23 Mar 2022
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jagtap N, Kumar CS, Lakhtakia S, Ramchandani M, Memon SF, Asif S, Kalapala R, Nabi Z, Basha J, Gupta R, Tandan M, Reddy DN. Adjuvant endobiliary radio-frequency ablation combined with self-expandable biliary metal stents for unresectable malignant hilar strictures: A pragmatic comparative study. Indian J Gastroenterol. 2025 Feb;44(1):72-79. doi: 10.1007/s12664-024-01668-1. Epub 2024 Sep 6.
PubMed 39240508
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SAFETY AND EFFICACY OF INTRA DUCTAL RADIO FREQUENCY ABLATION IN UNRESECTABLE MALIGNANT BILIARY OBSTRUCTION: PROSPECTIVE OBSERVATIONAL STUDY
- ClinicalTrials.gov ID
- NCT05320328
- Acronym / sponsor ID
- MBOP / RFA
- Conditions
- Bile Duct Neoplasms, Gall Bladder Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 10 Jun 2022 (estimated)
- Study completion
- 10 Dec 2022 (estimated)
- First posted
- 11 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Endoscopic retrograde cholangio pancreatography procedure will performed as per local standard procedure.After common bile duct cannulation,cholangiography will be performed (to confirm the stricture) followed by biliary sphincterotomy. All biliary strictures(Bismuth Type I/II/III/IV) will be enrolled for the study.
Patient opting for Uncovered self expandable metallic stent / Plastic stent will undergo biliary stent placement and considered under control arm Patient opting for radio frequency ablation + Uncovered SEMS/Plastic stent will undergo radio frequency ablation and biliary stent placement and considered under Study arm The RFA probe will be inserted into the bile duct alongwith the guidewire. Keeping the electrode overlapping the stricture, RFA will be performed using a power of 10W for 120 seconds. The electrode will be kept at the ablation site for an additional 1 minute to allow the RFA probe to cool before removal to prevent thermal injury of normal tissue and/or endoscope accessory channel. If the stricture is more than 3 cm, step-by-step RFA will be performed from the superior to inferior aspect. After RFA application, an uncovered SEMS/Plastic stent will be placed.
Detailed description
Placement of self expandable metallic stent is the standard of care in the palliative management of patients with malignant biliary strictures . Relieves biliary obstruction and jaundice.
Self expandable metallic stent provide efficient drainage and have superior patency rates compared with the plastic stents Endoscopic radio frequency ablation combined with stent placement can significantly prolong survival and the stent patency period without increasing the incidence of adverse events in patients with extra hepatic cholangiocarcinoma patient.
Compared to plastic/ metal stent placement alone the addition of radio frequency ablation to stent placement would have better outcomes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: Radio frequency ablationThe study group (A) will receive radio frequency ablation followed by uncovered Self expandable metal stent/Plastic stent placement (one or more)at same procedure. |
| 2 | – | –The control group (B) will receive uncovered Self expandable metal stent / Plastic stent (one or more) placement. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 50 Subjects
Key inclusion criteria (8 listed)
- Age 18-75 years
- Malignant biliary obstruction confirmed using computed tomography (CT) or abdominal magnetic resonance imaging(MRI), with pathological confirmation whenever possible;
- Clinical jaundice, a serum bilirubin level greater than 5 mg/dL, and/or cholangitis;
- ECOG performance status score≤2
- Un resectability or refusal to be surgically treated.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radio frequency ablationAlso: RFARadiofrequency ablation (RFA) uses heat to kill cancer cells. High-frequency electrical currents are passed through a special needle or probe called a needle electrode. The electrical current from the probe heats a small area containing cancer cells to high temperatures, killing the cancer cells. The area around the tumour is also usually treated because it may contain cancer cells. | Device | 1 |
Primary outcome
Prospectively evaluate the safety and efficacy of combining intraductal Radio frequency ablation with biliary metal/ plastic stent placement for patients with malignant biliary obstruction.
Time frame: 12 months
satety of radio frequency ablation assessed by complications/adverse effects post procedure and efficacy of the procedure will be assessed by stent patency at the end of one month
1 secondary outcome
Stent patency at 1 year
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Derived from this study: PubMed 39240508Jagtap N, Kumar CS, Lakhtakia S, Ramchandani M, Memon SF, Asif S, Kalapala R, Nabi Z, Basha J, Gupta R, Tandan M, Reddy DN. Adjuvant endobiliary radio-frequency ablation combined with self-expandable biliary metal stents for unresectable malignant hilar strictures: A pragmatic comparative study. Indian J Gastroenterol. 2025 Feb;44(1):72-79. doi: 10.1007/s12664-024-01668-1. Epub 2024 Sep 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bile Duct Neoplasms and Gall Bladder Carcinoma, run by Asian Institute of Gastroenterology, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sai Dr Kumar, MBBS MD (9121792373, saiaig21@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prospectively evaluate the safety and efficacy of combining intraductal Radio frequency ablation with biliary metal/ plastic stent placement for patients with malignant biliary obstruction. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05320328, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.