Three Dimension Laparoscopic Versus Open Surgery for Gallbladder Carcinoma

Study Overview
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Brief Summary
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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.

Official Title
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Three Dimension Laparoscopic Versus Open Surgery for Gallbladder Carcinoma. A Randomized Clinical Trial

Conditions
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Gallbladder Cancer, Surgery

Intervention / Treatment
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* Procedure: Three dimensional laparoscopic
* Procedure: Open


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D approach<br>Three dimensional laparoscopic cholecystectomy including segments IVB and V | Procedure: Three dimensional laparoscopic<br>* Three dimensional laparoscopic cholecystectomy including segments IVB and V<br>|
| Active Comparator: open approach<br>Open cholecystectomy including segments IVB and V | Procedure: Open<br>* Open cholecystectomy including segments IVB and V<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time | Operation time is definied as the from either skin incision or trocar placement to the entire skin closure. | 24 months | 
| Estimated blood loss | EBL is defined as the blood loss during the surgical procedure | 24 months | 
| Intraoperative blood transfusion | IBT is defined as whether the subjects receive blood transfusion during the surgical procedure | 24 months | 
| Length of stay | LOS is defined as the days between the surgery and hospital discharged | 24 months | 
| Complication rate | Complication rate is defined as the number of subjects developed complication divided the total subjects number | 24 months | 
| R0 rescetion rate | R0 rescetion rate for the carcinoma | 24 months |