NCT03383796

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 26, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

3 years

First QC Date

December 19, 2017

Last Update Submit

October 5, 2020

Conditions

Cholangiocarcinoma, PerihilarSurgery

Keywords

Cholangiocarcinoma perihilarthree dimension laparoscopic

Outcome Measures

Primary Outcomes (6)

  • Mortality

    Mortality was defined as any death that occurred in the 30 days after surgery or during the hospital stay.

    24 months

  • Length of Stay

    Length of stay was defined as the postoperative time interval in days.

    24 months

  • R0 Resection Rate

    Negative margin rate.

    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.

    24 months

  • TNM Staging

    According to AJCC guideline, each patients TNM staging were recorded.

    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.

    24 months

Study Arms (2)

3D approach

EXPERIMENTAL

Three dimensional laparoscopic resection for pCCA

Procedure: Three dimensional laparoscopic resection for pCCA

open approach

EXPERIMENTAL

Open resection for pCCA

Procedure: Open resection for pCCA

Interventions

Three dimensional laparoscopic resection for pCCAPROCEDURE

Three dimensional laparoscopic resection for pCCA

3D approach
Open resection for pCCAPROCEDURE

Open resection for pCCA

open approach

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tongji Hospital

Wuhan, Hubei, 430000, China

NOT YET RECRUITING

Tongji Hospital

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

Klatskin Tumor

Interventions

6-propylchromone-2-carboxylic acid

Condition Hierarchy (Ancestors)

CholangiocarcinomaAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

December 19, 2017

First Posted

December 26, 2017

Study Start

March 1, 2018

Primary Completion

March 1, 2021

Study Completion

March 1, 2022

Last Updated

October 8, 2020

Record last verified: 2020-10

Locations

CN(2)