Three Dimension Laparoscopic Versus Open Surgery for Gallbladder Carcinoma

NCT03491878 | Unknown DMC

• 1 other identifier: TJDBPS05
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

3D approach

EXPERIMENTAL

Three dimensional laparoscopic cholecystectomy including segments IVB and V

Procedure: Three dimensional laparoscopic

open approach

ACTIVE COMPARATOR

Open cholecystectomy including segments IVB and V

Procedure: Open

Interventions

Three dimensional laparoscopic PROCEDURE

Three dimensional laparoscopic cholecystectomy including segments IVB and V

3D approach

Open PROCEDURE

Open cholecystectomy including segments IVB and V

open approach

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven gallbladder carcinoma.
• Highly presumed malignancy with difficulties to obtain histological evidence.
• Preoperative staging work up performed by upper abdomen enhanced CT scan and showed no vessel involvment.
• The subject understands the nature of this trial and willing to comply.
• Ability to provide written informed consent.
• Patients treated with curative intent in accordance to international guidelines.

You may not qualify if:

• Distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node metastases, involvement of other organs.
• Patients with high operative risk as defined by the American Society of Anesthesiologists (ASA) score \>4.
• Synchronous malignancy in other organs.
• Palliative surgery.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (2)

Tongji Hospital

Wuhan, Hubei, 430000, China

Location

Tongji Hospital

Wuhan, Hubei, China

Location

MeSH Terms

Conditions

Gallbladder Neoplasms

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 1, 2018
• First Posted: April 9, 2018
• Study Start: May 1, 2018
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2022
• Last Updated: April 9, 2018

Record last verified: 2018-04

Locations

CN (2)