Ultrasonic Scalpel vs. Monopolar Electrocautery for D2 Distal Gastric Carcinoma Surgery (CGCT-01)

January 23, 2018 updated by: Jian-Kun Hu, West China Hospital

Ultrasonic Scalpel vs. Monopolar Electrocautery for D2 Distal Gastric Carcinoma Surgery: a Multicenter Randomized Controlled Trial

Gastric cancer as one of the most common gastrointestinal cancers, radical resection of primary lesions combined with dissection of regional lymph-nodes is acknowledged by surgeons all over the world. By the invented and adopted energy surgical instruments, surgical procedure is safer and easier than before. The newly surgical instruments reduce the post-operative mortality and morbidity combined easy procedures of surgery. As the most popular instruments used in the gastric surgery, ultrasonic scalpel and monopolar electrocautery were received lots of attention and concern. Some studies have shown some advantage of the two instruments, which were they can facilitate the surgical treatment and make the surgery safer and more effective. Although, some small retrospective sample reports claimed that ultrasonic scalpel brought benefit in blood loss, dissection lymph-node intraoperative complications and even postoperative complications. And Korea small sample randomized controlled trail presentation that ultrasonic scalpel can reduced blood loss and surgical duration. However, postoperative complications were with no statistical significance between the two instruments. Cost- effective analysis of the energy instruments is still controversial. Large sample randomized control trail with high quality is needed.

By the reasons above, a multicenter randomized controlled trial conducted by 9 hospitals from North to South in China aims to compare the clinical characteristics and outcomes, when using of the ultrasonic scalpel or monopolar electrocautery in traditional open gastrectomy. The aim of this study is to evaluate the outcomes of ultrasonic scalpel compared with monopolar electrocautery in D2 distal gastrectomy, include, intraoperative parameters, postoperative complications, cost data, and post-operative quality of life.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Standard Operating Procedure (SOP)

  1. Preoperative evaluation Patients satisfied with inclusion/exclusion criteria will be informed to join in the clinical study and signature the inform consent.
  2. Randomization preoperative evaluation found that R0, D2 Gastrectomy can be performed, the case will entrance into the Randomization period. Random numbers are computer-generated, with the third party applications.
  3. Surgical procedures The surgical treatments is adopted the traditional open gastrectomy approach and adjuvant D2 lymphadenectomy. The SOP of the surgical treatments are according to the Japanese Gastric Cancer treatments guidelines, 2010, Version 3.
  4. Postoperative recovery Postoperative recovery period need to collect those relevant parameters of all the patients. All the relevant parameters had definitely definition in the Case Report Form of this study.
  5. Follow-up The follow-up of this study divide into two parts, the postoperative quality of life and tumor characteristics outcomes. The information of the postoperative quality of life is collected by the EuroQol-5 Dimensions (EQ-5D) questionnaire in four postoperative time intervals. The tumor related outcomes included long-term postoperative complications, recurrence type, relapse free survival (months) and the overall survival (months).

Study Type

Interventional

Enrollment (Anticipated)

430

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 10000
        • Recruiting
        • Peking University Cancer Hospital and Institute
    • Guangdong
      • Guangzhou, Guangdong, China, 51000
        • Not yet recruiting
        • Guangdong General Hospital
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Not yet recruiting
        • The Third Affiliated Hospital, Harbin Medical University
        • Contact:
        • Principal Investigator:
          • Ying-Wei Xue, M.D., Ph.D.
    • Hubei
      • Wuhan, Hubei, China, 430000
        • Not yet recruiting
        • Union Hospital, Tongji Medical College
        • Contact:
    • Liaoning
      • Shengyang, Liaoning, China, 110001
        • Not yet recruiting
        • The First Affiliated Hospital of China Medical University
        • Contact:
        • Principal Investigator:
          • Zhen-Ning Wang, M.D., Ph.D.
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Not yet recruiting
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:
        • Principal Investigator:
          • Min Yan, M.D.,Ph.D.
      • Shanghai, Shanghai, China, 200000
        • Not yet recruiting
        • Zhongshan Hospital, Fudan University
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Not yet recruiting
        • Tianjin Medical University Cancer Institute and Hospital
        • Contact:
        • Principal Investigator:
          • Han Liang, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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. Preoperative endoscopy and biopsy confirmed gastric adenocarcinoma, and predictively feasible of traditional open D2 distal gastrectomy;
  2. Predictively resectable diseases, of preoperative staging Japanese Gastric Cancer Association (JGCA) 14th Edition cT2N0M0-T4aN3M0, IB-IIIC, except T4b;
  3. Age：≤75 years, or ≥18 years;
  4. Without serious disease;
  5. Patients without previous history of upper abdominal surgery;
  6. WHO performance score <2;
  7. No limit to sexual and race;
  8. informed consent required;

Exclusion Criteria:

  1. primary lesion cannot be resected in the pattern of transabdominal distal gastrectomy, but for total gastrectomy, Whipple's procedure, or combined organ resection (include the cholecystectomy) or with a transthoracic approach surgery;
  2. Patient undergo emergency surgery due to bleeding or perforation;
  3. Patients with other gastric malignant diseases, such as lymphoma and stromal tumors, etc;
  4. Patients suffering from malignant diseases before the study;
  5. Patients with other severe complications cannot tolerate surgery: such as severe heart and lung diseases, heart function below clinical stage 2, uncontrollable hypertension, pulmonary infection, moderate to severe Chronic Obstruction Pulmonary Disease (COPD), chronic bronchitis, severe diabetes and / or renal insufficiency, severe hepatitis and / or function below the rank of CHILD B grade, and severe malnutrition, etc.
  6. Patients treated with neoadjuvant chemotherapy or radiation therapy which might affect the efficacy observation;
  7. Severity mental diseases;
  8. After signature the Clinical trial agreement, patients and their agent will quit the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasonic scalpel surgery group
During the procedures of the abdominal approach D2 distal gastrectomy, use ultrasonic scalpel (Device) to coagulation and cut off blood vessel, separate and dissection lymph-nodes; some great vessels can ligation by nylon, silk line or Hemolock.
Device: Ultrasonic scalpel
During the procedures of the abdominal approach D2 distal gastrectomy, use ultrasonic scalpel (Device) to coagulation and cut off blood vessel, separate and dissection lymph-nodes
Experimental: Monopolar electrocautery surgery group
During the procedures of the abdominal approach D2 distal gastrectomy, use monopolar electrocautery (Device) to coagulation and cut off blood vessel, separate and dissection lymph-nodes; some great vessels can ligation by nylon, silk line or Hemolock.
Device: Monopolar electrocautery
During the procedures of the abdominal approach D2 distal gastrectomy, use the monopolar electrocautery (Device) to coagulation and cut off blood vessel, separate and dissection lymph-nodes .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical duration
Time Frame: Intraoperative
From the skin incision to finish the suture of abdominal wall
Intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood loss
Time Frame: Intraoperative
The intraoperative blood loss
Intraoperative
Number of harvested and positive lymph nodes
Time Frame: Postoperative
Number of harvested and positive lymph nodes by pathological results
Postoperative
Intraoperative Mortality and Morbidity
Time Frame: Intraoperative
Evaluation the intraoperative mortality and morbidity
Intraoperative
Survival outcome
Time Frame: 3 years
the survival outcomes include the 3-year overall survival rate and 3-year disease free survival rate
3 years
Postoperative Mortality and Morbidity
Time Frame: Postoperative (30 days)
Evaluation the postoperative (30 days) mortality and morbidity
Postoperative (30 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Investigators

  • Principal Investigator: Jian-Kun Hu, Ph.D., M.D., West China hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

April 7, 2014

First Submitted That Met QC Criteria

May 2, 2014

First Posted (Estimate)

May 5, 2014

Study Record Updates

Last Update Posted (Actual)

January 25, 2018

Last Update Submitted That Met QC Criteria

January 23, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGCT-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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