Cholangiocarcinoma, HilarNCT06106750
Endoscopic Scissors Cutting Nasobiliary Duct VS Bilateral Plastic Stent
A study testing Endoscopic nasobiliary duct cutting and Bilateral plastic stent in people with Cholangiocarcinoma, Hilar and Biliary Stricture, run by First People's Hospital of Hangzhou at 1 site in China.
Trial summary
The purpose of this study is to explore the efficacy and safety of endoscopic scissors cutting nasobiliary ducts in the treatment of malignant hilar biliary tract stenosis Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cholangiocarcinoma, Hilar, Biliary Stricture, Hilar Cholangiocarcinoma
- What is being tested?
- Endoscopic nasobiliary duct cutting and Bilateral plastic stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 1 Jan 2026
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years old and under 80 years old who were planned to carry out ERCP for malignant hilar biliary duct stenosis
- Clinically and pathologically confirmed malignant hilar biliary duct stenosis
- MRCP determines Bismuth classification: II-IV type
- Comply with research procedures and sign the informed consent form
Who cannot join
- The patient has multiple organ dysfunction and cannot tolerate endoscopic treatment
- The patient has undergone biliary drainage (endoscopic, percutaneous, or surgical)
- The patient is currently suffering from cholangitis
- The patient is participating in other clinical trials
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310006
Jianfeng Yang, Doctor, (+86)13454132186, yjf-1976@163.com, yjf3303@zju.edu.cn
Wangyang Chen, (+86)18868108329, 22118301@zju.edu.cn
About this study
Official title: The Efficacy and Safety of Endoscopic Scissors Cutting Nasobiliary Ducts in the Treatment of Malignant Hilar Biliary Tract Stenosis
The purpose of this study is to explore the efficacy and safety of endoscopic scissors cutting nasobiliary ducts in the treatment of malignant hilar biliary tract stenosis
Read the detailed description
The early diagnosis of hilar bile duct stenosis is difficult, and when the patient is diagnosed, the opportunity for surgical radical resection is lost, resulting in a poor prognosis. Effective palliative treatment can significantly improve their quality of life and survival time. The method of cutting nasobiliary ducts with endoscopic scissors has many advantages. Firstly, there are multiple lateral foramen of the nasobiliary duct, which increases the drainage area. Secondly, the nasobiliary duct can be retained in the secondary bile duct, which is difficult to achieve with a conventional stent. The use of nasobiliary ducts can also reduce the difficulty of converting from external drainage to internal drainage.
- Conditions
- Cholangiocarcinoma, Hilar, Biliary Stricture, Hilar Cholangiocarcinoma, Klatskin Tumor, Biliary Disease, Bile Duct Diseases
- Being tested
- Endoscopic nasobiliary duct cutting, Bilateral plastic stent
- Keywords
- Endoscopic Retrograde Cholangiopancreatography, Nasobiliary Duct, Stent, Endoscopic Drainage
- Medical subject headings
- Klatskin Tumor, Gallbladder Diseases, Bile Duct Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic nasobiliary duct cuttingDevice
Endoscopic retrograde cholangiopancreatography and endoscopic nasobiliary duct placement and drainage are conducted first. Upon achieving a postoperative state marked by satisfactory nasobiliary duct drainage and overall patient stability, the procedure entails the employment of endoscopic scissors. The tools are applied to make an incision on the external segment of the nasobiliary duct, positioned beyond the aperture of the primary duodenal papilla. Then extracting the severed nasobiliary duct and retaining the portion inside the duct.
Bilateral plastic stentDevice
Standard protocol for the placement of bilateral biliary plastic stents in the management of malignant hilar biliary tract stenosis
| Study group | Role | What they receive |
|---|---|---|
| Nasobiliary duct cutting | Experimental | Endoscopic retrograde cholangiopancreatography and endoscopic nasobiliary duct placement and drainage are conducted first. Upon achieving a postoperative state marked by satisfactory nasobiliary duct drainage and overall patient stability, the procedure entails the employment of endoscopic scissors. The tools are applied to make an incision on the external segment of the nasobiliary duct, positioned beyond the aperture of the primary duodenal papilla. Then, extracting the severed nasobiliary duct and retaining the portion inside it. Receives: Device: Endoscopic nasobiliary duct cutting |
| Bilateral plastic stent | Active comparator | Standard protocol for the placement of bilateral biliary plastic stents in the management of malignant hilar biliary tract stenosis Receives: Device: Bilateral plastic stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of cholangitis
Cholangitis that occurred within 1 month after endoscopic retrograde cholangiopancreatography(ERCP).
Measured: 1 month
Clinical success
Clinical success was defined that the decrease in the total bilirubin level to less than 50% of the pretreatment value within 1 week or to less than 75% within 1 month.
Measured: 1 month
Secondary outcomes (2)
Re-intervention
Re-intervention was defined that endoscopic or percutaneous procedure to improve biliary drainage for jaundice or cholangitis after successful placement.
Measured: 6 month
Adverse events
ERCP-related adverse events
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start1 Jan 2022
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cholangiocarcinoma, HilarStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianfeng Yang, First People's Hospital of Hangzhou
- Investigators
- Jianfeng Yang, Doctor, Principal investigator, First People's Hospital of Hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106750
- Sponsor's protocol ID
- 2023-10
- Status last verified
- Oct 2023
- First submitted
- 24 Oct 2023
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kawashima H, Itoh A, Ohno E, Itoh Y, Ebata T, Nagino M, Goto H, Hirooka Y. Preoperative endoscopic nasobiliary drainage in 164 consecutive patients with suspected perihilar cholangiocarcinoma: a retrospective study of efficacy and risk factors related to complications. Ann Surg. 2013 Jan;257(1):121-7. doi: 10.1097/SLA.0b013e318262b2e9.
PubMed 22895398Kawakami H, Kuwatani M, Onodera M, Haba S, Eto K, Ehira N, Yamato H, Kudo T, Tanaka E, Hirano S, Kondo S, Asaka M. Endoscopic nasobiliary drainage is the most suitable preoperative biliary drainage method in the management of patients with hilar cholangiocarcinoma. J Gastroenterol. 2011 Feb;46(2):242-8. doi: 10.1007/s00535-010-0298-1. Epub 2010 Aug 11.
PubMed 20700608Hakuta R, Kogure H, Nakai Y, Kawakami H, Maguchi H, Mukai T, Iwashita T, Saito T, Togawa O, Matsubara S, Hayashi T, Maetani I, Ito Y, Hasebe O, Itoi T, Hanada K, Isayama H. Unilateral versus Bilateral Endoscopic Nasobiliary Drainage and Subsequent Metal Stent Placement for Unresectable Malignant Hilar Obstruction: A Multicenter Randomized Controlled Trial. J Clin Med. 2021 Jan 8;10(2):206. doi: 10.3390/jcm10020206.
PubMed 33430020Sugiura R, Kuwatani M, Hayashi T, Yoshida M, Ihara H, Yamato H, Onodera M, Katanuma A; Hokkaido Interventional EUS/ERCP study (HONEST) group. Endoscopic Nasobiliary Drainage Comparable with Endoscopic Biliary Stenting as a Preoperative Drainage Method for Malignant Hilar Biliary Obstruction: A Multicenter Retrospective Study. Digestion. 2022;103(3):205-216. doi: 10.1159/000521510. Epub 2022 Jan 26.
PubMed 35081535
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Endoscopic Scissors Cutting Nasobiliary Ducts in the Treatment of Malignant Hilar Biliary Tract Stenosis
- ClinicalTrials.gov ID
- NCT06106750
- Acronym / sponsor ID
- 2023-10
- Conditions
- Cholangiocarcinoma, Hilar, Biliary Stricture, Hilar Cholangiocarcinoma, Klatskin Tumor, Biliary Disease, Bile Duct Diseases
- Keywords
- Endoscopic Retrograde Cholangiopancreatography, Nasobiliary Duct, Stent, Endoscopic Drainage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 30 Oct 2023 (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.
The purpose of this study is to explore the efficacy and safety of endoscopic scissors cutting nasobiliary ducts in the treatment of malignant hilar biliary tract stenosis
Detailed description
The early diagnosis of hilar bile duct stenosis is difficult, and when the patient is diagnosed, the opportunity for surgical radical resection is lost, resulting in a poor prognosis. Effective palliative treatment can significantly improve their quality of life and survival time. The method of cutting nasobiliary ducts with endoscopic scissors has many advantages. Firstly, there are multiple lateral foramen of the nasobiliary duct, which increases the drainage area. Secondly, the nasobiliary duct can be retained in the secondary bile duct, which is difficult to achieve with a conventional stent. The use of nasobiliary ducts can also reduce the difficulty of converting from external drainage to internal drainage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasobiliary duct cutting | Experimental | Device: Endoscopic nasobiliary duct cuttingEndoscopic retrograde cholangiopancreatography and endoscopic nasobiliary duct placement and drainage are conducted first. Upon achieving a postoperative state marked by satisfactory nasobiliary duct drainage and overall patient stability, the procedure entails the employment of endoscopic scissors. The tools are applied to make an incision on the external segment of the nasobiliary duct, positioned beyond the aperture of the primary duodenal papilla. Then, extracting the severed nasobiliary duct and retaining the portion inside it. |
| Bilateral plastic stent | Active comparator | Device: Bilateral plastic stentStandard protocol for the placement of bilateral biliary plastic stents in the management of malignant hilar biliary tract stenosis |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients over 18 years old and under 80 years old who were planned to carry out ERCP for malignant hilar biliary duct stenosis
- Clinically and pathologically confirmed malignant hilar biliary duct stenosis
- MRCP determines Bismuth classification: II-IV type
- Comply with research procedures and sign the informed consent form
Key exclusion criteria (5 listed)
- The patient has multiple organ dysfunction and cannot tolerate endoscopic treatment
- The patient has undergone biliary drainage (endoscopic, percutaneous, or surgical)
- The patient is currently suffering from cholangitis
- The patient is participating in other clinical trials
- Inability to provide informed consent
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 |
|---|---|---|
| Endoscopic nasobiliary duct cuttingEndoscopic retrograde cholangiopancreatography and endoscopic nasobiliary duct placement and drainage are conducted first. Upon achieving a postoperative state marked by satisfactory nasobiliary duct drainage and overall patient stability, the procedure entails the employment of endoscopic scissors. The tools are applied to make an incision on the external segment of the nasobiliary duct, positioned beyond the aperture of the primary duodenal papilla. Then extracting the severed nasobiliary duct and retaining the portion inside the duct. | Device | Nasobiliary duct cutting |
| Bilateral plastic stentStandard protocol for the placement of bilateral biliary plastic stents in the management of malignant hilar biliary tract stenosis | Device | Bilateral plastic stent |
Primary outcome
The occurrence of cholangitis
Time frame: 1 month
Cholangitis that occurred within 1 month after endoscopic retrograde cholangiopancreatography(ERCP).
Clinical success
Time frame: 1 month
Clinical success was defined that the decrease in the total bilirubin level to less than 50% of the pretreatment value within 1 week or to less than 75% within 1 month.
2 secondary outcomes
Re-intervention
Time frame: 6 month
Adverse events
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Results publication: PubMed 22895398Kawashima H, Itoh A, Ohno E, Itoh Y, Ebata T, Nagino M, Goto H, Hirooka Y. Preoperative endoscopic nasobiliary drainage in 164 consecutive patients with suspected perihilar cholangiocarcinoma: a retrospective study of efficacy and risk factors related to complications. Ann Surg. 2013 Jan;257(1):121-7. doi: 10.1097/SLA.0b013e318262b2e9.
- Results publication: PubMed 20700608Kawakami H, Kuwatani M, Onodera M, Haba S, Eto K, Ehira N, Yamato H, Kudo T, Tanaka E, Hirano S, Kondo S, Asaka M. Endoscopic nasobiliary drainage is the most suitable preoperative biliary drainage method in the management of patients with hilar cholangiocarcinoma. J Gastroenterol. 2011 Feb;46(2):242-8. doi: 10.1007/s00535-010-0298-1. Epub 2010 Aug 11.
- Results publication: PubMed 33430020Hakuta R, Kogure H, Nakai Y, Kawakami H, Maguchi H, Mukai T, Iwashita T, Saito T, Togawa O, Matsubara S, Hayashi T, Maetani I, Ito Y, Hasebe O, Itoi T, Hanada K, Isayama H. Unilateral versus Bilateral Endoscopic Nasobiliary Drainage and Subsequent Metal Stent Placement for Unresectable Malignant Hilar Obstruction: A Multicenter Randomized Controlled Trial. J Clin Med. 2021 Jan 8;10(2):206. doi: 10.3390/jcm10020206.
- Results publication: PubMed 35081535Sugiura R, Kuwatani M, Hayashi T, Yoshida M, Ihara H, Yamato H, Onodera M, Katanuma A; Hokkaido Interventional EUS/ERCP study (HONEST) group. Endoscopic Nasobiliary Drainage Comparable with Endoscopic Biliary Stenting as a Preoperative Drainage Method for Malignant Hilar Biliary Obstruction: A Multicenter Retrospective Study. Digestion. 2022;103(3):205-216. doi: 10.1159/000521510. Epub 2022 Jan 26.
- 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.
Jianfeng Yang, Doctor principal investigator
First People's Hospital of Hangzhou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic nasobiliary duct cutting and Bilateral plastic stent in people with Cholangiocarcinoma, Hilar and Biliary Stricture, run by First People's Hospital of Hangzhou at 1 site in China.
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 4 inclusion and 5 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 30 Oct 2023. 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 China. 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 Jianfeng Yang, Doctor ((+86)13454132186, yjf-1976@163.com, yjf3303@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of cholangitis (time frame: 1 month). The study lists 2 primary outcomes in all. 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 NCT06106750, which also lists 4 linked publications.
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 30 Oct 2023.