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Three Dimension Laparoscopic Versus Open Surgery for Gallbladder Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03491878
Recruitment Status : Not yet recruiting
First Posted : April 9, 2018
Last Update Posted : April 9, 2018
Information provided by (Responsible Party):
Renyi Qin, Tongji Hospital

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.

Condition or disease Intervention/treatment Phase
Gallbladder Cancer Surgery Procedure: Three dimensional laparoscopic Procedure: Open Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Three Dimension Laparoscopic Versus Open Surgery for Gallbladder Carcinoma. A Randomized Clinical Trial
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Operation time [ Time Frame: 24 months ]
    Operation time is definied as the from either skin incision or trocar placement to the entire skin closure.

  2. Estimated blood loss [ Time Frame: 24 months ]
    EBL is defined as the blood loss during the surgical procedure

  3. Intraoperative blood transfusion [ Time Frame: 24 months ]
    IBT is defined as whether the subjects receive blood transfusion during the surgical procedure

  4. Length of stay [ Time Frame: 24 months ]
    LOS is defined as the days between the surgery and hospital discharged

  5. Complication rate [ Time Frame: 24 months ]
    Complication rate is defined as the number of subjects developed complication divided the total subjects number

  6. R0 rescetion rate [ Time Frame: 24 months ]
    R0 rescetion rate for the carcinoma

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03491878

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China, Hubei
Tongji Hospital
Wuhan, Hubei, China, 430000
Tongji Hospital
Wuhan, Hubei, China
Sponsors and Collaborators
Tongji Hospital

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Responsible Party: Renyi Qin, Professor, Tongji Hospital Identifier: NCT03491878    
Other Study ID Numbers: TJDBPS05
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gallbladder Neoplasms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases