Gallbladder CancerNCT03491878
Three Dimension Laparoscopic Versus Open Surgery for Gallbladder Carcinoma
A study testing Three dimensional laparoscopic and Open in people with Gallbladder Cancer and Surgery, run by Tongji Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gallbladder Cancer, Surgery
- What is being tested?
- Three dimensional laparoscopic and Open
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesChina
- Study dates
- 1 May 2018to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Three Dimension Laparoscopic Versus Open Surgery for Gallbladder Carcinoma. A Randomized Clinical Trial
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.
- Conditions
- Gallbladder Cancer, Surgery
- Being tested
- Three dimensional laparoscopic, Open
- Medical subject headings
- Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three dimensional laparoscopicProcedure or surgery
Three dimensional laparoscopic cholecystectomy including segments IVB and V
OpenProcedure or surgery
Open cholecystectomy including segments IVB and V
| Study group | Role | What they receive |
|---|---|---|
| 3D approach | Experimental | Three dimensional laparoscopic cholecystectomy including segments IVB and V Receives: Procedure: Three dimensional laparoscopic |
| open approach | Active comparator | Open cholecystectomy including segments IVB and V Receives: Procedure: Open |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operation time
Operation time is definied as the from either skin incision or trocar placement to the entire skin closure.
Measured: 24 months
Estimated blood loss
EBL is defined as the blood loss during the surgical procedure
Measured: 24 months
Intraoperative blood transfusion
IBT is defined as whether the subjects receive blood transfusion during the surgical procedure
Measured: 24 months
Length of stay
LOS is defined as the days between the surgery and hospital discharged
Measured: 24 months
Complication rate
Complication rate is defined as the number of subjects developed complication divided the total subjects number
Measured: 24 months
R0 rescetion rate
R0 rescetion rate for the carcinoma
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start1 May 2018 (estimated)
- Primary completion1 May 2021 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallbladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renyi Qin, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491878
- Sponsor's protocol ID
- TJDBPS05
- Status last verified
- Apr 2018
- First submitted
- 1 Apr 2018
- Last updated
- 9 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Dimension Laparoscopic Versus Open Surgery for Gallbladder Carcinoma. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03491878
- Acronym / sponsor ID
- TJDBPS05
- Conditions
- Gallbladder Cancer, Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 May 2018 (estimated)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 9 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D approach | Experimental | Procedure: Three dimensional laparoscopicThree dimensional laparoscopic cholecystectomy including segments IVB and V |
| open approach | Active comparator | Procedure: OpenOpen cholecystectomy including segments IVB and V |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Three dimensional laparoscopicThree dimensional laparoscopic cholecystectomy including segments IVB and V | Procedure or surgery | 3D approach |
| OpenOpen cholecystectomy including segments IVB and V | Procedure or surgery | open approach |
Primary outcome
Operation time
Time frame: 24 months
Operation time is definied as the from either skin incision or trocar placement to the entire skin closure.
Estimated blood loss
Time frame: 24 months
EBL is defined as the blood loss during the surgical procedure
Intraoperative blood transfusion
Time frame: 24 months
IBT is defined as whether the subjects receive blood transfusion during the surgical procedure
Length of stay
Time frame: 24 months
LOS is defined as the days between the surgery and hospital discharged
Complication rate
Time frame: 24 months
Complication rate is defined as the number of subjects developed complication divided the total subjects number
R0 rescetion rate
Time frame: 24 months
R0 rescetion rate for the carcinoma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Three dimensional laparoscopic and Open in people with Gallbladder Cancer and Surgery, run by Tongji Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operation time (time frame: 24 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2018.