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

Quality of Life Clinical Trial

— CGCT-01  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02130752
• Other study ID #: CGCT-01
• Status: Recruiting
• Phase: N/A
• First received: April 7, 2014
• Last updated: January 23, 2018
• Start date: October 2014
• Est. completion date: October 2022

Study information

• Verified date: January 2018
• Source: West China Hospital
• Contact: Jian-Kun Hu, M.D.,Ph.D.
• Phone: +8618980601504
• Email: hujkwch[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 430
• Est. completion date: October 2022
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Loss, Surgical
• External Causes of Morbidity and Mortality
• Gastric Cancer
• Monopolar Electrocautery
• Operation Time
• Quality of Life
• Stomach Neoplasms
• Surgery
• Ultrasonic Scalpel

Intervention

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 .
• 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

Locations

Country	Name	City	State
China	Peking University Cancer Hospital and Institute	Beijing	Beijing
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	Guangdong General Hospital	Guangzhou	Guangdong
China	The Third Affiliated Hospital, Harbin Medical University	Harbin	Heilongjiang
China	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai
China	The First Affiliated Hospital of China Medical University	Shengyang	Liaoning
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin
China	Union Hospital, Tongji Medical College	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical duration	From the skin incision to finish the suture of abdominal wall	Intraoperative
Secondary	Blood loss	The intraoperative blood loss	Intraoperative
Secondary	Number of harvested and positive lymph nodes	Number of harvested and positive lymph nodes by pathological results	Postoperative
Secondary	Intraoperative Mortality and Morbidity	Evaluation the intraoperative mortality and morbidity	Intraoperative
Secondary	Survival outcome	the survival outcomes include the 3-year overall survival rate and 3-year disease free survival rate	3 years
Secondary	Postoperative Mortality and Morbidity	Evaluation the postoperative (30 days) mortality and morbidity	Postoperative (30 days)