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Comparing Three Dimension Laparoscopic Versus Open Surgery for Perihiliar Cholangiocarcinoma

Primary Purpose

Cholangiocarcinoma, Perihilar, Surgery

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Three dimensional laparoscopic resection for pCCA
Open resection for pCCA
Sponsored by
Tongji Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholangiocarcinoma, Perihilar focused on measuring Cholangiocarcinoma perihilar, three dimension laparoscopic

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tongji Hospital
  • Tongji HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

3D approach

open approach

Arm Description

Three dimensional laparoscopic resection for pCCA

Open resection for pCCA

Outcomes

Primary Outcome Measures

Mortality
Mortality was defined as any death that occurred in the 30 days after surgery or during the hospital stay.
Length of Stay
Length of stay was defined as the postoperative time interval in days.
R0 Resection Rate
Negative margin rate.
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.
TNM Staging
According to AJCC guideline, each patients TNM staging were recorded.
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.

Secondary Outcome Measures

Full Information

First Posted
December 19, 2017
Last Updated
October 5, 2020
Sponsor
Tongji Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03383796
Brief Title
Comparing Three Dimension Laparoscopic Versus Open Surgery for Perihiliar Cholangiocarcinoma
Official Title
Randomized Clinical Trial Comparing Three Dimension Laparoscopic and Open Surgery for Perihiliar Cholangiocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
March 1, 2021 (Anticipated)
Study Completion Date
March 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangiocarcinoma, Perihilar, Surgery
Keywords
Cholangiocarcinoma perihilar, three dimension laparoscopic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
3D approach
Arm Type
Experimental
Arm Description
Three dimensional laparoscopic resection for pCCA
Arm Title
open approach
Arm Type
Experimental
Arm Description
Open resection for pCCA
Intervention Type
Procedure
Intervention Name(s)
Three dimensional laparoscopic resection for pCCA
Intervention Description
Three dimensional laparoscopic resection for pCCA
Intervention Type
Procedure
Intervention Name(s)
Open resection for pCCA
Intervention Description
Open resection for pCCA
Primary Outcome Measure Information:
Title
Mortality
Description
Mortality was defined as any death that occurred in the 30 days after surgery or during the hospital stay.
Time Frame
24 months
Title
Length of Stay
Description
Length of stay was defined as the postoperative time interval in days.
Time Frame
24 months
Title
R0 Resection Rate
Description
Negative margin rate.
Time Frame
24 months
Title
Bile leakage
Description
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
Title
TNM Staging
Description
According to AJCC guideline, each patients TNM staging were recorded.
Time Frame
24 months
Title
Complication rate
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hang Zhang, M.D.
Phone
+8613407148260
Email
okashiiyo@126.com
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Wang, Dr.
Phone
+8602783665314
Email
wangmin0013128@aliyun.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Comparing Three Dimension Laparoscopic Versus Open Surgery for Perihiliar Cholangiocarcinoma

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