Three Dimension Laparoscopic Versus Open Surgery for Gallbladder Carcinoma

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

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.

Study Overview

• Status: Unknown
• Conditions: Surgery; Gallbladder Cancer
• Intervention / Treatment: Procedure: Three dimensional laparoscopic; Procedure: Open

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Tongji Hospital
    • Wuhan, Hubei, China, 430000
      • Tongji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3D approach; Three dimensional laparoscopic cholecystectomy including segments IVB and V	Procedure: Three dimensional laparoscopic; Three dimensional laparoscopic cholecystectomy including segments IVB and V
Active Comparator: open approach; Open cholecystectomy including segments IVB and V	Procedure: Open; Open cholecystectomy including segments IVB and V

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2018
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): May 1, 2022

Study Registration Dates

• First Submitted: April 1, 2018
• First Submitted That Met QC Criteria: April 1, 2018
• First Posted (Actual): April 9, 2018

Study Record Updates

• Last Update Posted (Actual): April 9, 2018
• Last Update Submitted That Met QC Criteria: April 1, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gallbladder Diseases; Biliary Tract Diseases; Biliary Tract Neoplasms; Gallbladder Neoplasms
• Other Study ID Numbers: TJDBPS05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No