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

Sponsor

West China Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT02130752

Collaborator

(none)

430

Enrollment

Locations

Arms

Duration (Months)

47.8

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Gastric Cancer Surgery Ultrasonic Scalpel Monopolar Electrocautery Operation Time Blood Loss, Surgical Quality of Life External Causes of Morbidity and Mortality	Device: Monopolar electrocautery Device: Ultrasonic scalpel	N/A

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

430 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Oct 1, 2014

Anticipated Primary Completion Date :

Oct 1, 2019

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

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 .

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 .

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University Cancer Hospital and Institute	Beijing	Beijing	China	10000
2	Guangdong General Hospital	Guangzhou	Guangdong	China	51000
3	The Third Affiliated Hospital, Harbin Medical University	Harbin	Heilongjiang	China	150000
4	Union Hospital, Tongji Medical College	Wuhan	Hubei	China	430000
5	The First Affiliated Hospital of China Medical University	Shengyang	Liaoning	China	110001
6	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai	China	200000
7	Zhongshan Hospital, Fudan University	Shanghai	Shanghai	China	200000
8	West China Hospital, Sichuan University	Chengdu	Sichuan	China	610041
9	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin	China	300060