Gallbladder Cancer, Surgery
Conditions
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.
Interventions
PROCEDUREThree dimensional laparoscopic
Three dimensional laparoscopic cholecystectomy including segments IVB and V
PROCEDUREOpen
Open cholecystectomy including segments IVB and V
Sponsors
Tongji Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Histologically proven gallbladder carcinoma. 2. Highly presumed malignancy with difficulties to obtain histological evidence. 3. Preoperative staging work up performed by upper abdomen enhanced CT scan and showed no vessel involvment. 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. Patients with high operative risk as defined by the American Society of Anesthesiologists (ASA) score \>4. 3. Synchronous malignancy in other organs. 4. Palliative surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operation time | 24 months | Operation time is definied as the from either skin incision or trocar placement to the entire skin closure. |
| Estimated blood loss | 24 months | EBL is defined as the blood loss during the surgical procedure |
| Intraoperative blood transfusion | 24 months | IBT is defined as whether the subjects receive blood transfusion during the surgical procedure |
| Length of stay | 24 months | LOS is defined as the days between the surgery and hospital discharged |
| Complication rate | 24 months | Complication rate is defined as the number of subjects developed complication divided the total subjects number |
| R0 rescetion rate | 24 months | R0 rescetion rate for the carcinoma |
Countries
China
Outcome results
None listed