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

Primary Purpose

Gastric Cancer, Surgery, Ultrasonic Scalpel

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Monopolar electrocautery
Ultrasonic scalpel
Sponsored by
West China Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gastric Cancer focused on measuring Stomach Neoplasms, Operative Time, Gastrectomy, Surgical Hemorrhage, Mortality, Morbidity

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking University Cancer Hospital and InstituteRecruiting
  • Guangdong General Hospital
  • The Third Affiliated Hospital, Harbin Medical University
  • Union Hospital, Tongji Medical College
  • The First Affiliated Hospital of China Medical University
  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
  • Zhongshan Hospital, Fudan University
  • West China Hospital, Sichuan UniversityRecruiting
  • Tianjin Medical University Cancer Institute and Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ultrasonic scalpel surgery group

Monopolar electrocautery surgery group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Surgical duration
From the skin incision to finish the suture of abdominal wall

Secondary Outcome Measures

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

Full Information

First Posted
April 7, 2014
Last Updated
January 23, 2018
Sponsor
West China Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02130752
Brief Title
Ultrasonic Scalpel vs. Monopolar Electrocautery for D2 Distal Gastric Carcinoma Surgery
Acronym
CGCT-01
Official Title
Ultrasonic Scalpel vs. Monopolar Electrocautery for D2 Distal Gastric Carcinoma Surgery: a Multicenter Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Standard Operating Procedure (SOP) Preoperative evaluation Patients satisfied with inclusion/exclusion criteria will be informed to join in the clinical study and signature the inform consent. 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. 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. 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Surgery, Ultrasonic Scalpel, Monopolar Electrocautery, Operation Time, Blood Loss, Surgical, Quality of Life, External Causes of Morbidity and Mortality
Keywords
Stomach Neoplasms, Operative Time, Gastrectomy, Surgical Hemorrhage, Mortality, Morbidity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
430 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrasonic scalpel surgery group
Arm Type
Experimental
Arm Description
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.
Arm Title
Monopolar electrocautery surgery group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Monopolar electrocautery
Intervention Description
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 .
Intervention Type
Device
Intervention Name(s)
Ultrasonic scalpel
Intervention Description
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
Primary Outcome Measure Information:
Title
Surgical duration
Description
From the skin incision to finish the suture of abdominal wall
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Blood loss
Description
The intraoperative blood loss
Time Frame
Intraoperative
Title
Number of harvested and positive lymph nodes
Description
Number of harvested and positive lymph nodes by pathological results
Time Frame
Postoperative
Title
Intraoperative Mortality and Morbidity
Description
Evaluation the intraoperative mortality and morbidity
Time Frame
Intraoperative
Title
Survival outcome
Description
the survival outcomes include the 3-year overall survival rate and 3-year disease free survival rate
Time Frame
3 years
Title
Postoperative Mortality and Morbidity
Description
Evaluation the postoperative (30 days) mortality and morbidity
Time Frame
Postoperative (30 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Preoperative endoscopy and biopsy confirmed gastric adenocarcinoma, and predictively feasible of traditional open D2 distal gastrectomy; Predictively resectable diseases, of preoperative staging Japanese Gastric Cancer Association (JGCA) 14th Edition cT2N0M0-T4aN3M0, IB-IIIC, except T4b; Age:≤75 years, or ≥18 years; Without serious disease; Patients without previous history of upper abdominal surgery; WHO performance score <2; No limit to sexual and race; informed consent required; Exclusion Criteria: 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; Patient undergo emergency surgery due to bleeding or perforation; Patients with other gastric malignant diseases, such as lymphoma and stromal tumors, etc; Patients suffering from malignant diseases before the study; 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. Patients treated with neoadjuvant chemotherapy or radiation therapy which might affect the efficacy observation; Severity mental diseases; After signature the Clinical trial agreement, patients and their agent will quit the trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jian-Kun Hu, M.D.,Ph.D.
Phone
+8618980601504
Email
hujkwch@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wei-Han Zhang, M.D.
Phone
+8613438919160
Email
weihanwch@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian-Kun Hu, Ph.D., M.D.
Organizational Affiliation
West China Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Cancer Hospital and Institute
City
Beijing
State/Province
Beijing
ZIP/Postal Code
10000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zi-Yu Li, M.D.
Email
ligregory369@hotmail.com
First Name & Middle Initial & Last Name & Degree
Zi-Yu Li, M.D., Ph.D.
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
51000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Li, M.D., Ph.D.
Email
liyong-lucky@21cn.com
First Name & Middle Initial & Last Name & Degree
Yong Li, M.D., Ph.D.
Facility Name
The Third Affiliated Hospital, Harbin Medical University
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying-Wei Xue, M.D., Ph.D.
Email
XYW801@163.com
First Name & Middle Initial & Last Name & Degree
Ying-Wei Xue, M.D., Ph.D.
Facility Name
Union Hospital, Tongji Medical College
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kai-Xiong Tao, M.D.,Ph.D.
Email
tao_kaixiong@163.com
First Name & Middle Initial & Last Name & Degree
Kai-Xiong Tao, M.D.,Ph.D.
Facility Name
The First Affiliated Hospital of China Medical University
City
Shengyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhen-Ning Wang, M.D., Ph.D.
Email
josieon826@sina.cn
First Name & Middle Initial & Last Name & Degree
Zhen-Ning Wang, M.D., Ph.D.
Facility Name
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Yan, M.D., Ph.D.
Email
ymrjym@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Min Yan, M.D.,Ph.D.
Facility Name
Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi-Hong Sun, M.D., Ph.D.
Email
sun.yihong@zs-hospital.sh.cn
First Name & Middle Initial & Last Name & Degree
Yi-Hong Sun, M.D., Ph.D.
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian-Kun Hu, M.D.,Ph.D.
Phone
+8618980601504
Email
hujkwch@126.com
First Name & Middle Initial & Last Name & Degree
Jian-Kun Hu, M.D.
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Han Liang, M.D., Ph.D.
Email
tjlianghan@126.com
First Name & Middle Initial & Last Name & Degree
Han Liang, M.D., Ph.D.

12. IPD Sharing Statement

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Ultrasonic Scalpel vs. Monopolar Electrocautery for D2 Distal Gastric Carcinoma Surgery

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