Gastric CancerCGCT-01NCT02130752
Ultrasonic Scalpel vs. Monopolar Electrocautery for D2 Distal Gastric Carcinoma Surgery
A study testing Monopolar electrocautery and Ultrasonic scalpel in people with Gastric Cancer and Surgery, run by West China Hospital at 9 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer, Surgery, Ultrasonic Scalpel
- What is being tested?
- Monopolar electrocautery and Ultrasonic scalpel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 9 sitesChina
- Study dates
- Oct 2014to Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
Peking University Cancer Hospital and Institute
Beijing, Beijing Municipality, 10000
Zi-Yu Li, M.D., ligregory369@hotmail.com
Zi-Yu Li, M.D., Ph.D.
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Jian-Kun Hu, M.D.,Ph.D., +8618980601504, hujkwch@126.com
Jian-Kun Hu, M.D.
- Not yet recruiting
Guangdong General Hospital
Guangzhou, Guangdong, 51000
Yong Li, M.D., Ph.D., liyong-lucky@21cn.com
Yong Li, M.D., Ph.D.
- Not yet recruiting
The Third Affiliated Hospital, Harbin Medical University
Harbin, Heilongjiang, 150000
Ying-Wei Xue, M.D., Ph.D., XYW801@163.com
Ying-Wei Xue, M.D., Ph.D.
- Not yet recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200000
Min Yan, M.D., Ph.D., ymrjym@yahoo.com.cn
Min Yan, M.D.,Ph.D.
- Not yet recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200000
Yi-Hong Sun, M.D., Ph.D., sun.yihong@zs-hospital.sh.cn
Yi-Hong Sun, M.D., Ph.D.
- Not yet recruiting
The First Affiliated Hospital of China Medical University
Shengyang, Liaoning, 110001
Zhen-Ning Wang, M.D., Ph.D., josieon826@sina.cn
Zhen-Ning Wang, M.D., Ph.D.
- Not yet recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Han Liang, M.D., Ph.D., tjlianghan@126.com
Han Liang, M.D., Ph.D.
- Not yet recruiting
Union Hospital, Tongji Medical College
Wuhan, Hubei, 430000
Kai-Xiong Tao, M.D.,Ph.D., tao_kaixiong@163.com
Kai-Xiong Tao, M.D.,Ph.D.
About this study
Official title: Ultrasonic Scalpel vs. Monopolar Electrocautery for D2 Distal Gastric Carcinoma Surgery: a Multicenter Randomized Controlled Trial
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.
Read the 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).
- Conditions
- Gastric Cancer, Surgery, Ultrasonic Scalpel, Monopolar Electrocautery, Operation Time, Blood Loss, Surgical
- Being tested
- Monopolar electrocautery, Ultrasonic scalpel
- Keywords
- Stomach Neoplasms, Operative Time, Gastrectomy, Surgical Hemorrhage, Mortality, Morbidity
- Medical subject headings
- Stomach Neoplasms, Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monopolar electrocauteryDevice
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 scalpelDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Ultrasonic scalpel surgery group | Experimental | 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. Receives: Device: Ultrasonic scalpel |
| Monopolar electrocautery surgery group | Experimental | 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. Receives: Device: Monopolar electrocautery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical duration
From the skin incision to finish the suture of abdominal wall
Measured: Intraoperative
Secondary outcomes (5)
Blood loss
The intraoperative blood loss
Measured: Intraoperative
Number of harvested and positive lymph nodes
Number of harvested and positive lymph nodes by pathological results
Measured: Postoperative
Intraoperative Mortality and Morbidity
Evaluation the intraoperative mortality and morbidity
Measured: Intraoperative
Survival outcome
the survival outcomes include the 3-year overall survival rate and 3-year disease free survival rate
Measured: 3 years
Postoperative Mortality and Morbidity
Evaluation the postoperative (30 days) mortality and morbidity
Measured: Postoperative (30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2019 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian-Kun Hu, West China Hospital
- Investigators
- Jian-Kun Hu, Ph.D., M.D., Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130752
- Sponsor's protocol ID
- CGCT-01
- Acronym
- CGCT-01
- Status last verified
- Jan 2018
- First submitted
- 7 Apr 2014
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 38000074
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonic Scalpel vs. Monopolar Electrocautery for D2 Distal Gastric Carcinoma Surgery: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02130752
- Acronym / sponsor ID
- CGCT-01 / CGCT-01
- Conditions
- Gastric Cancer, Surgery, Ultrasonic Scalpel, Monopolar Electrocautery, Operation Time, Blood Loss, Surgical
- Keywords
- Stomach Neoplasms, Operative Time, Gastrectomy, Surgical Hemorrhage, Mortality, Morbidity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 5 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasonic scalpel surgery group | Experimental | Device: Ultrasonic scalpelDuring 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 | Experimental | Device: Monopolar electrocauteryDuring 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monopolar electrocauteryDuring 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 . | Device | Monopolar electrocautery surgery group |
| Ultrasonic scalpelDuring 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 | Device | Ultrasonic scalpel surgery group |
Primary outcome
Surgical duration
Time frame: Intraoperative
From the skin incision to finish the suture of abdominal wall
5 secondary outcomes
Blood loss
Time frame: Intraoperative
Number of harvested and positive lymph nodes
Time frame: Postoperative
Intraoperative Mortality and Morbidity
Time frame: Intraoperative
Survival outcome
Time frame: 3 years
Postoperative Mortality and Morbidity
Time frame: Postoperative (30 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Derived from this study: PubMed 38000074Wu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian-Kun Hu, Ph.D., M.D. principal investigator
West China Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monopolar electrocautery and Ultrasonic scalpel in people with Gastric Cancer and Surgery, run by West China Hospital at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian-Kun Hu, M.D.,Ph.D. (+8618980601504, hujkwch@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical duration (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02130752, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018.