Three Dimension Laparoscopic Versus Open Surgery for Gallbladder Carcinoma
Primary Purpose
Gallbladder Cancer, Surgery
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Three dimensional laparoscopic
Open
Sponsored by
About this trial
This is an interventional treatment trial for Gallbladder Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically proven gallbladder carcinoma.
- Highly presumed malignancy with difficulties to obtain histological evidence.
- Preoperative staging work up performed by upper abdomen enhanced CT scan and showed no vessel involvment.
- 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.
- Patients with high operative risk as defined by the American Society of Anesthesiologists (ASA) score >4.
- Synchronous malignancy in other organs.
- Palliative surgery.
Sites / Locations
- Tongji Hospital
- Tongji Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
3D approach
open approach
Arm Description
Three dimensional laparoscopic cholecystectomy including segments IVB and V
Open cholecystectomy including segments IVB and V
Outcomes
Primary Outcome Measures
Operation time
Operation time is definied as the from either skin incision or trocar placement to the entire skin closure.
Estimated blood loss
EBL is defined as the blood loss during the surgical procedure
Intraoperative blood transfusion
IBT is defined as whether the subjects receive blood transfusion during the surgical procedure
Length of stay
LOS is defined as the days between the surgery and hospital discharged
Complication rate
Complication rate is defined as the number of subjects developed complication divided the total subjects number
R0 rescetion rate
R0 rescetion rate for the carcinoma
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03491878
Brief Title
Three Dimension Laparoscopic Versus Open Surgery for Gallbladder Carcinoma
Official Title
Three Dimension Laparoscopic Versus Open Surgery for Gallbladder Carcinoma. A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2018 (Anticipated)
Primary Completion Date
May 1, 2021 (Anticipated)
Study Completion Date
May 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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Introduction: Surgery is the only potential curative approach for the highly lethal gallbladder carcinoma. The laparoscopic surgery has developed rapidly since invented. As a kind of minimally invasive surgery, laparoscopic cholecystectomy including segmentg IVB and V is preferred by most of surgeons. There have been studies comparing intraoperative blood loss, postoperative morbidity, length of hospital stay and costs of laparoscopic cholecystectomy over open surgery. However, randomized controlled trials are still lacking but clearly required to reveal whether the laparoscopic approach or the open surgery is the better option for treating gallbladder carcinoma. We hypothesize that incidence of postoperative complications is lower, and time to functional recovery is shorter after laparosopic compared with open approach, even in an enhanced recovery setting.
Methods/design: We designed this prospective, randomized, controlled trial with two treatment approaches, laparoscopic versus open surgery for gallbladder carcinoma. The trial hypothesis is that laparoscopic approach 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 four years including prearrangement, follow-up and analyses.
Discussion: Although several studies have discussed different surgical approaches for gallbladder carcinoma treatment, this trial will be a thorough RCT comparing laparoscopic and open surgery for gallbladder carcinoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gallbladder Cancer, Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
3D approach
Arm Type
Experimental
Arm Description
Three dimensional laparoscopic cholecystectomy including segments IVB and V
Arm Title
open approach
Arm Type
Active Comparator
Arm Description
Open cholecystectomy including segments IVB and V
Intervention Type
Procedure
Intervention Name(s)
Three dimensional laparoscopic
Intervention Description
Three dimensional laparoscopic cholecystectomy including segments IVB and V
Intervention Type
Procedure
Intervention Name(s)
Open
Intervention Description
Open cholecystectomy including segments IVB and V
Primary Outcome Measure Information:
Title
Operation time
Description
Operation time is definied as the from either skin incision or trocar placement to the entire skin closure.
Time Frame
24 months
Title
Estimated blood loss
Description
EBL is defined as the blood loss during the surgical procedure
Time Frame
24 months
Title
Intraoperative blood transfusion
Description
IBT is defined as whether the subjects receive blood transfusion during the surgical procedure
Time Frame
24 months
Title
Length of stay
Description
LOS is defined as the days between the surgery and hospital discharged
Time Frame
24 months
Title
Complication rate
Description
Complication rate is defined as the number of subjects developed complication divided the total subjects number
Time Frame
24 months
Title
R0 rescetion rate
Description
R0 rescetion rate for the carcinoma
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 gallbladder carcinoma.
Highly presumed malignancy with difficulties to obtain histological evidence.
Preoperative staging work up performed by upper abdomen enhanced CT scan and showed no vessel involvment.
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.
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
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Three Dimension Laparoscopic Versus Open Surgery for Gallbladder Carcinoma
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