An interventional study of Three dimensional laparoscopic resection for pCCA and Open resection for pCCA in Cholangiocarcinoma, Perihilar and Surgery, sponsored by Tongji Hospital. Status unknown at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-10-08.
Sponsored by Tongji 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 17th largest by planned enrollment of the 22 interventional ones that give a count, is one of 3 that started in 2018, is one of 10 with no phase, and was the 9th 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 to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
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. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 30 is below the median of 55 across 56 interventional studies indexed under Klatskin Tumor.
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:
Tongji Hospital is the lead sponsor of 387 studies on the registry; 210 are open to participants now.
Tongji 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 |
Add all 3 to your calendar (.ics) → With an account.
Among the 29 studies in Klatskin Tumor with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Cholangiocarcinoma (CCA) is the most common biliary tract malignancy and the second most common primary hepatic malignancy. The prognosis of CCA is dismal. Surgery is the only potentially curative treatment, but the majority of patients present with advanced stage disease, and recurrence after resection is common. It is classified into intrahepatic (iCCA), perihilar (pCCA), and distal (dCCA) subtypes. Among all, pCCA is the most common subtype.
This is a prospective, randomized, controlled multicenter trial with two treatment arms, three dimension laparoscopic approach versus open approach. The trial hypothesis is that three dimension laparoscopic surgery has advantages in postoperative recoveries and be equivalent in operation time, oncological results and long-term follow-up compared with open counterpart. The duration of the entire trial is two years including prearrangement, follow-up and analyses.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Three dimensional laparoscopic resection for pCCA
Procedure: Three dimensional laparoscopic resection for pCCA
Open resection for pCCA
Procedure: Open resection for pCCA
Three dimensional laparoscopic resection for pCCA
Open resection for pCCA
Mortality
Mortality was defined as any death that occurred in the 30 days after surgery or during the hospital stay.
Time frame: 24 months
Length of Stay
Length of stay was defined as the postoperative time interval in days.
Time frame: 24 months
R0 Resection Rate
Negative margin rate.
Time frame: 24 months
Bile leakage
The drain bilirubin was monitored after surgery, any elevation for the bilirubin level or the diagnostic puncture proved bile fluid in abdominal cavity.
Time frame: 24 months
TNM Staging
According to AJCC guideline, each patients TNM staging were recorded.
Time frame: 24 months
Complication rate
Complication Rate Measure Description Any complication mentioned in the protocol should be carefully record and analyzed, including postoperative hemorrhage, postoperative pancreatic fistula, etc.
Time frame: 24 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Mar 2018 (actual). Primary completion is estimated for Mar 2021, 36 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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