Comparing Three Dimension Laparoscopic Versus Open Surgery for Perihiliar Cholangiocarcinoma
NCT ID: NCT03383796
Last Updated: 2020-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2018-03-01
2022-03-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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3D approach
Three dimensional laparoscopic resection for pCCA
Three dimensional laparoscopic resection for pCCA
Three dimensional laparoscopic resection for pCCA
open approach
Open resection for pCCA
Open resection for pCCA
Open resection for pCCA
Interventions
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Three dimensional laparoscopic resection for pCCA
Three dimensional laparoscopic resection for pCCA
Open resection for pCCA
Open resection for pCCA
Eligibility Criteria
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Inclusion Criteria
2. Highly presumed perihlar bile duct malignancy with difficulties to obtain histological evidence.
3. Preoperative staging work up performed by upper abdomen enhanced CT scan.
4. The subject understands the nature of this trial and willing to comply.
5. Ability to provide written informed consent.
6. Patients treated with curative intent in accordance to international guidelines
Exclusion Criteria
2. Subjects undergoing any part for hepatectomy.
3. Patients with high operative risk as defined by the American Society of Anesthesiologists (ASA) score \>4.
4. Synchronous malignancy in other organs.
5. Palliative surgery
18 Years
75 Years
ALL
No
Sponsors
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Tongji Hospital
OTHER
Responsible Party
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Renyi Qin
Clinical professor
Locations
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Tongji Hospital
Wuhan, Hubei, China
Tongji Hospital
Wuhan, Hubei, China
Countries
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Facility Contacts
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Other Identifiers
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TJDBPS02
Identifier Type: -
Identifier Source: org_study_id
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