Three Dimension Laparoscopic Versus Open Surgery for Gallbladder Carcinoma

NCT ID: NCT03491878

Last Updated: 2018-04-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2022-05-01

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.

Conditions

Gallbladder Cancer; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

3D approach

Three dimensional laparoscopic cholecystectomy including segments IVB and V

Group Type: EXPERIMENTAL

Three dimensional laparoscopic

Intervention Type: PROCEDURE

Three dimensional laparoscopic cholecystectomy including segments IVB and V

open approach

Open cholecystectomy including segments IVB and V

Group Type: ACTIVE_COMPARATOR

Open

Intervention Type: PROCEDURE

Open cholecystectomy including segments IVB and V

Interventions

Three dimensional laparoscopic

Three dimensional laparoscopic cholecystectomy including segments IVB and V

Intervention Type: PROCEDURE

Open

Open cholecystectomy including segments IVB and V

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tongji Hospital

OTHER

Sponsor Role: lead

Responsible Party

Renyi Qin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tongji Hospital

Wuhan, Hubei, China

Tongji Hospital

Wuhan, Hubei, China

Countries

China

Other Identifiers

TJDBPS05

Identifier Type: -

Identifier Source: org_study_id