Three Dimension Laparoscopic Versus Open Surgery for Gallbladder Carcinoma

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03491878
• Other study ID #: TJDBPS05
• Status: Not yet recruiting
• Phase: N/A
• First received: April 1, 2018
• Last updated: April 1, 2018
• Start date: May 1, 2018
• Est. completion date: May 1, 2022

Study information

• Verified date: April 2018
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gallbladder Cancer
• Gallbladder Neoplasms
• Surgery

Intervention

Procedure:
• Three dimensional laparoscopic
Three dimensional laparoscopic cholecystectomy including segments IVB and V
• Open
Open cholecystectomy including segments IVB and V

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei
China	Tongji Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

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