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

Not Applicable

• Conditions: Surgery; Ultrasonic Scalpel; Quality of Life; Gastric Cancer; Monopolar Electrocautery; Operation Time; External Causes of Morbidity and Mortality; Blood Loss, Surgical
• Interventions: Device: Monopolar electrocautery; Device: Ultrasonic scalpel

• Registration Number: NCT02130752
• Lead Sponsor: West China Hospital

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)

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 Timeline

• Study First Submitted: 2014-04-07
• Study First Submitted QC: 2014-05-02
• Study First Posted: 2014-05-05
• Study Start: 2014-10
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-25
• Primary Completion: 2019-10
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 430

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monopolar electrocautery surgery group	Monopolar electrocautery	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.
Ultrasonic scalpel surgery group	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; some great vessels can ligation by nylon, silk line or Hemolock.

Primary Outcome Measures

Name	Time	Method
Surgical duration	Intraoperative	From the skin incision to finish the suture of abdominal wall

Secondary Outcome Measures

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

Trial Locations

Locations (9)

West China Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China

Guangdong General Hospital; 🇨🇳 Guangzhou, Guangdong, China

The First Affiliated Hospital of China Medical University; 🇨🇳 Shengyang, Liaoning, China

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China

Union Hospital, Tongji Medical College; 🇨🇳 Wuhan, Hubei, China

The Third Affiliated Hospital, Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin, China

Peking University Cancer Hospital and Institute; 🇨🇳 Beijing, Beijing, China