Cholangiocarcinoma, PerihilarNCT03383796
Comparing Three Dimension Laparoscopic Versus Open Surgery for Perihiliar Cholangiocarcinoma
A study testing Three dimensional laparoscopic resection for pCCA and Open resection for pCCA in people with Cholangiocarcinoma, Perihilar and Surgery, run by Tongji Hospital at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cholangiocarcinoma, Perihilar, Surgery
- What is being tested?
- Three dimensional laparoscopic resection for pCCA and Open resection for pCCA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesChina
- Study dates
- 1 Mar 2018to 1 Mar 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven pCCA.
- Highly presumed perihlar bile duct malignancy with difficulties to obtain histological evidence.
- Preoperative staging work up performed by upper abdomen enhanced CT scan.
- The subject understands the nature of this trial and willing to comply.
- Ability to provide written informed consent.
- Patients treated with curative intent in accordance to international guidelines
Who cannot join
- Distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node metastases, involvement of other organs.
- Subjects undergoing any part for hepatectomy.
- Patients with high operative risk as defined by the American Society of Anesthesiologists (ASA) score >4.
- Synchronous malignancy in other organs.
- Palliative surgery
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Not yet recruiting
Tongji Hospital
Wuhan, Hubei, 430000
Hang Zhang, M.D., +8613407148260, okashiiyo@126.com
- Recruiting
Tongji Hospital
Wuhan, Hubei
Min Wang, Dr., +8602783665314, wangmin0013128@aliyun.com
About this study
Official title: Randomized Clinical Trial Comparing Three Dimension Laparoscopic and Open Surgery for Perihiliar Cholangiocarcinoma
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.
- Conditions
- Cholangiocarcinoma, Perihilar, Surgery
- Being tested
- Three dimensional laparoscopic resection for pCCA, Open resection for pCCA
- Keywords
- Cholangiocarcinoma perihilar, three dimension laparoscopic
- Medical subject headings
- Klatskin Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three dimensional laparoscopic resection for pCCAProcedure or surgery
Three dimensional laparoscopic resection for pCCA
Open resection for pCCAProcedure or surgery
Open resection for pCCA
| Study group | Role | What they receive |
|---|---|---|
| 3D approach | Experimental | Three dimensional laparoscopic resection for pCCA Receives: Procedure: Three dimensional laparoscopic resection for pCCA |
| open approach | Experimental | Open resection for pCCA Receives: Procedure: Open resection for pCCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality was defined as any death that occurred in the 30 days after surgery or during the hospital stay.
Measured: 24 months
Length of Stay
Length of stay was defined as the postoperative time interval in days.
Measured: 24 months
R0 Resection Rate
Negative margin rate.
Measured: 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.
Measured: 24 months
TNM Staging
According to AJCC guideline, each patients TNM staging were recorded.
Measured: 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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start1 Mar 2018
- Primary completion1 Mar 2021 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholangiocarcinoma, PerihilarStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renyi Qin, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383796
- Sponsor's protocol ID
- TJDBPS02
- Status last verified
- Oct 2020
- First submitted
- 19 Dec 2017
- Last updated
- 8 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Comparing Three Dimension Laparoscopic and Open Surgery for Perihiliar Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT03383796
- Acronym / sponsor ID
- TJDBPS02
- Conditions
- Cholangiocarcinoma, Perihilar, Surgery
- Keywords
- Cholangiocarcinoma perihilar, three dimension laparoscopic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 26 Dec 2017 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D approach | Experimental | Procedure: Three dimensional laparoscopic resection for pCCAThree dimensional laparoscopic resection for pCCA |
| open approach | Experimental | Procedure: Open resection for pCCAOpen resection for pCCA |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically proven pCCA.
- Highly presumed perihlar bile duct malignancy with difficulties to obtain histological evidence.
- Preoperative staging work up performed by upper abdomen enhanced CT scan.
- The subject understands the nature of this trial and willing to comply.
- Ability to provide written informed consent.
Key exclusion criteria (5 listed)
- Distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node metastases, involvement of other organs.
- Subjects undergoing any part for hepatectomy.
- Patients with high operative risk as defined by the American Society of Anesthesiologists (ASA) score >4.
- Synchronous malignancy in other organs.
- Palliative surgery
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 |
|---|---|---|
| Three dimensional laparoscopic resection for pCCAThree dimensional laparoscopic resection for pCCA | Procedure or surgery | 3D approach |
| Open resection for pCCAOpen resection for pCCA | Procedure or surgery | open approach |
Primary outcome
Mortality
Time frame: 24 months
Mortality was defined as any death that occurred in the 30 days after surgery or during the hospital stay.
Length of Stay
Time frame: 24 months
Length of stay was defined as the postoperative time interval in days.
R0 Resection Rate
Time frame: 24 months
Negative margin rate.
Bile leakage
Time frame: 24 months
The drain bilirubin was monitored after surgery, any elevation for the bilirubin level or the diagnostic puncture proved bile fluid in abdominal cavity.
TNM Staging
Time frame: 24 months
According to AJCC guideline, each patients TNM staging were recorded.
Complication rate
Time frame: 24 months
Complication Rate Measure Description Any complication mentioned in the protocol should be carefully record and analyzed, including postoperative hemorrhage, postoperative pancreatic fistula, etc.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Three dimensional laparoscopic resection for pCCA and Open resection for pCCA in people with Cholangiocarcinoma, Perihilar and Surgery, run by Tongji Hospital at 2 sites 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 6 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 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 24 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2020.