Clinical trial NCT03491878: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Gallbladder Cancer
Surgery
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2018-04-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Operation time
timeFrame: 24 months
measure: Estimated blood loss
timeFrame: 24 months
measure: Intraoperative blood transfusion
timeFrame: 24 months
measure: Length of stay
timeFrame: 24 months
measure: Complication rate
timeFrame: 24 months
measure: R0 rescetion rate
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
References: