An interventional study of Endoscopic scissors and Biliary stent in Endoscopic Retrograde Cholangiopancreatography and Klatskin Tumor, sponsored by Changhai Hospital. Withdrawn at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-25.
Sponsored by Changhai Hospital · Not applicable, Interventional, and Treatment
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Among 29 studies in Klatskin Tumor with a site in China — 9 open to participants now, 11 under way, 1 of them phase 3. Klatskin Tumor · China.
Among the 29 studies in Klatskin Tumor with a site in China, this one is the 22nd largest by enrollment of the 22 interventional ones that give a count, is one of 4 that started in 2017, is one of 10 with no phase, and was the 8th registered.
82 studies on the registry are indexed under Klatskin Tumor; 27 are open to participants now.
Browse Klatskin Tumor studies →9 of the 29 studies in Klatskin Tumor with a site in China are open now. Recruiting first, the newest first:
Shanghai Zhongshan Hospital · Sites in China
Ages 18+
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Sites in China
Ages 18–80
Jinbo Yue · Sites in China
Ages 18–75
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Sites in China
Ages 18–75
First People's Hospital of Hangzhou · Sites in China
Ages 18–80
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 19 Klatskin Tumor studies recruiting now, 11 (58%) set no upper age limit and 5 (26%) stop at 75 or younger; none take children under 18; 1 takes healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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29 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 10 · Phase 3 2
First in 2011; this study’s year is marked. 4 started in 2017.
By drug class, each counting the studies that test any of its medicines:
Median enrollment 61 across the 22 interventional studies, 200 across the 7 observational. Of the 8 that completed or were terminated, 0 (0%) have results posted.
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2 of 29 have an industry lead sponsor. The 10 most frequent:
Changhai Hospital is the lead sponsor of 355 studies on the registry; 136 are open to participants now.
Changhai Hospital has 1 study filed under Klatskin Tumor — fewer than ten, so there is no comparison to draw.
3 of the studies in Klatskin Tumor with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06717464Tianjin Medical University Cancer Institute and HospitalToripalimab Combined With Capecitabine as Postoperative Adjuvant Therapy for Patients With Resectable Advanced Extrahepatic Biliary Tract Cancer | 2026-12-31 |
| NCT05430698Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityPD-1 Antibody Plus GEMOX as Postoperative Adjuvant Therapy in Perihilar Cholangiocarcinoma | 2027-01-31 |
| NCT07030140Jinbo YuePhase II Study of Neoadjuvant Tislelizumab Plus Radiotherapy and GP Chemotherapy for Borderline/Unresectable Hilar Cholangiocarcinoma | 2027-07-01 |
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Among the 29 studies in Klatskin Tumor with a site in China, from their registry updates:
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The purpose of this study is to evaluate application value of the endoscopic cutting technique in the treatment of malignant hilar biliary strictures.
The management unresectable malignant hilar biliary strictures is still very difficult in spite of the rapid development of new endoscopic devices.The application of stent (plastic or metallic) has allowed us to achieve successful drainage. However,there are many complications related to the placement of stents,such as cholangitis,high rate of re-intervention,and so on. The application of endoscopic cutting technique is considered to reduce these complication.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Endoscopic nasobiliary drainage for malignant hilar biliary strictures at first， and application of endoscopic cutting technique followed.
Device: Endoscopic scissors
Standard placement of biliary stent for malignant hilar biliary strictures.
Device: Biliary stent
Application of endoscopic cutting technique following endoscopic nasobiliary drainage in the treatment of malignant hilar biliary strictures.
Standard placement of biliary stent
occurrence of acute cholangitis
Acute cholangitis is defined as cholangitis that occurred within 30 days after endoscopic retrograde cholangiopancreatography(ERCP).
Time frame: 30 days
Clinical success
Clinical success was defined as a decrease in the total bilirubin level to ≤50% of the pretreatment value within 1 week or to ≤75% within 4 weeks.
Time frame: 30 days
Re-intervention
Re-intervention was defined as any type of endoscopic or percutaneous procedure necessary to improve biliary drainage for jaundice or cholangitis after successful placement.
Time frame: 6 months
early adverse
Early adverse event was defined as any ERCP-related adverse event within 4 weeks and a late event was defined as one that occurred after 4 weeks.
Time frame: 30 days
Plan to share: No
Ran from Nov 2017 to primary completion in Sep 2019, 21 months.
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This study is withdrawn, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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