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Comparing Three Dimension Laparoscopic Versus Open Surgery for Perihiliar Cholangiocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03383796
Recruitment Status : Recruiting
First Posted : December 26, 2017
Last Update Posted : October 8, 2020
Information provided by (Responsible Party):
Renyi Qin, Tongji Hospital

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Cholangiocarcinoma, Perihilar Surgery Procedure: Three dimensional laparoscopic resection for pCCA Procedure: Open resection for pCCA Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial Comparing Three Dimension Laparoscopic and Open Surgery for Perihiliar Cholangiocarcinoma
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 3D approach
Three dimensional laparoscopic resection for pCCA
Procedure: Three dimensional laparoscopic resection for pCCA
Three dimensional laparoscopic resection for pCCA

Experimental: open approach
Open resection for pCCA
Procedure: Open resection for pCCA
Open resection for pCCA

Primary Outcome Measures :
  1. Mortality [ Time Frame: 24 months ]
    Mortality was defined as any death that occurred in the 30 days after surgery or during the hospital stay.

  2. Length of Stay [ Time Frame: 24 months ]
    Length of stay was defined as the postoperative time interval in days.

  3. R0 Resection Rate [ Time Frame: 24 months ]
    Negative margin rate.

  4. 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.

  5. TNM Staging [ Time Frame: 24 months ]
    According to AJCC guideline, each patients TNM staging were recorded.

  6. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically proven pCCA.
  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:

  1. Distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node metastases, involvement of other organs.
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03383796

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China, Hubei
Tongji Hospital Not yet recruiting
Wuhan, Hubei, China, 430000
Contact: Hang Zhang, M.D.    +8613407148260   
Tongji Hospital Recruiting
Wuhan, Hubei, China
Contact: Min Wang, Dr.    +8602783665314   
Sponsors and Collaborators
Tongji Hospital
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Responsible Party: Renyi Qin, Clinical professor, Tongji Hospital Identifier: NCT03383796    
Other Study ID Numbers: TJDBPS02
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Renyi Qin, Tongji Hospital:
Cholangiocarcinoma perihilar
three dimension laparoscopic
Additional relevant MeSH terms:
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Klatskin Tumor
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type