Ultrasonic Scalpel vs. Monopolar Electrocautery for D2 Distal Gastric Carcinoma Surgery
CGCT-01
1 other identifier
interventional
430
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable gastric-cancer
Started Oct 2014
Longer than P75 for not_applicable gastric-cancer
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 7, 2014
CompletedFirst Posted
Study publicly available on registry
May 5, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedJanuary 25, 2018
January 1, 2018
5 years
April 7, 2014
January 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Surgical duration
From the skin incision to finish the suture of abdominal wall
Intraoperative
Secondary Outcomes (5)
Blood loss
Intraoperative
Number of harvested and positive lymph nodes
Postoperative
Intraoperative Mortality and Morbidity
Intraoperative
Survival outcome
3 years
Postoperative Mortality and Morbidity
Postoperative (30 days)
Study Arms (2)
Ultrasonic scalpel surgery group
EXPERIMENTALDuring 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.
Monopolar electrocautery surgery group
EXPERIMENTALDuring 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.
Interventions
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 .
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
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Peking University Cancer Hospital and Institute
Beijing, Beijing Municipality, 10000, China
Guangdong General Hospital
Guangzhou, Guangdong, 51000, China
The Third Affiliated Hospital, Harbin Medical University
Harbin, Heilongjiang, 150000, China
Union Hospital, Tongji Medical College
Wuhan, Hubei, 430000, China
The First Affiliated Hospital of China Medical University
Shengyang, Liaoning, 110001, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200000, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200000, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
Related Publications (1)
Wu J, Wang H, Yin X, Wang Y, Lu Z, Zhang J, Zhang Y, Xue Y. Normalization weighted combination scores re-evaluate TNM staging of gastric cancer: a retrospective cohort study based on a multicenter database. Int J Surg. 2024 Jan 1;110(1):11-22. doi: 10.1097/JS9.0000000000000726.
PMID: 38000074DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jian-Kun Hu, Ph.D., M.D.
West China Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Deputy director of Department of Gastrointestinal Surgery
Study Record Dates
First Submitted
April 7, 2014
First Posted
May 5, 2014
Study Start
October 1, 2014
Primary Completion
October 1, 2019
Study Completion
October 1, 2022
Last Updated
January 25, 2018
Record last verified: 2018-01