Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection (ICGTinLG)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03050879 |
|
Recruitment Status :
Completed
First Posted : February 13, 2017
Last Update Posted : September 9, 2020
|
Sponsor:
Fujian Medical University
Information provided by (Responsible Party):
Chang-Ming Huang, Prof., Fujian Medical University Union Hospital
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
The purpose of this study is to explore the clinical outcomes of Indocyanine Green Tracer using in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma（cT1-4a, N-/+, M0）.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Stomach Neoplasms Indocyanine Green | Drug: Indocyanine Green Tracer | Phase 2 |
Indocyanine Green Tracer is often applied in surgery for early gastric adenocarcinoma. Its application in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma is at the stage of cases accumulation, method studying and clinical research. There is no prospective studies to identify the clinical outcomes of Indocyanine Green Tracer using in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma.
On the basis of more than 3000 cases of laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma, we want to apply the Indocyanine Green Tracer, a cheap, easy to operate and no radiation pollution way, to predict the positive lymph nodes in gastric adenocarcinoma, to guid the scope of laparoscopic lymph node dissection for gastric adenocarcinoma.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 266 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Prospective Randomized Controlled Trials on Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Gastric Cancer |
| Actual Study Start Date : | October 15, 2017 |
| Actual Primary Completion Date : | July 13, 2019 |
| Actual Study Completion Date : | July 13, 2019 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Stomach Cancer
Drug Information available for:
Indocyanine green
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Indocyanine Green Tracer
Indocyanine Green Tracer will be used in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma in this group.
|
Drug: Indocyanine Green Tracer
Laparoscopic gastrectomy with lymph node dissection for gastric cancer using Indocyanine Green Tracer
Other Name: ICG |
|
Active Comparator: No Indocyanine Green Tracer
Indocyanine Green Tracer will not be used in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma in this group.
|
Drug: Indocyanine Green Tracer
Laparoscopic gastrectomy with lymph node dissection for gastric cancer using Indocyanine Green Tracer
Other Name: ICG |
Primary Outcome Measures :
- Total Number of Retrieved Lymph Nodes [ Time Frame: 14 days ]Compare total number of retrieved lymph nodes in both group.
Secondary Outcome Measures :
- The rate of fluorescence [ Time Frame: 14 days ]The number of fluorescent lymph node in experimental group is divided by the total number of lymph nodes in active experimental group
- Positive rate [ Time Frame: 14 days ]The number of positive lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in experimental group
- False positive rate [ Time Frame: 14 days ]The number of negative lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in experimental group
- Negative rate [ Time Frame: 14 days ]The number of negative lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in experimental group
- False negative rate [ Time Frame: 14 days ]The number of positive lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in experimental group
- Number of Metastasis Lymph Nodes [ Time Frame: 14 days ]Compare number of positive lymph nodes in both group.
- Metastasis rate of lymph node [ Time Frame: 14 days ]Compare metastasis rate of lymph node in both group
- Morbidity and mortality rates [ Time Frame: 30 days ]This is for the early postoperative complication and mortality, which defined as the event observed within 30 days after surgery.
- 3-year disease free survival rate [ Time Frame: 36 months ]
- 3-year recurrence pattern [ Time Frame: 36 months ]Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.
- Postoperative recovery course [ Time Frame: 10 days ]Time to first ambulation, flatus, liquid diet and soft diet, duration of postoperative hospital stay and postoperative pain are used to assess the postoperative recovery course.Visual analog pain score method is used to evaluate the difference of postoperative pain degree.
- Operation time [ Time Frame: 1 day ]
- The variation of weight [ Time Frame: 3, 6, 9 and 12 months ]The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
- Intraoperative blood loss [ Time Frame: 1 day ]
- Conversive rate [ Time Frame: 1 day ]
- Intraoperative morbidity rates [ Time Frame: 1 day ]The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
- Incision length [ Time Frame: 1 day ]
- The variation of cholesterol [ Time Frame: 3, 6, 9 and 12 months ]The variation of cholesterol in millimole/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
- The variation of album [ Time Frame: 3, 6, 9 and 12 months ]The variation of album in gram/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
- The results of endoscopy [ Time Frame: 3, 6, 9 and 12 months ]The incidence of reflux esophagitis under the endoscopy on postoperative 3 and 12 months are used to access the postoperative quality of life.
- The variation of body temperature [ Time Frame: 8 days ]The daily highest body temperature in degree centigrade before discharge are recorded to access the inflammatory and immune response.
- The variation of white blood cell count [ Time Frame: Preoperative 3 days and postoperative 1, 3, and 5 days ]The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
- The variation of hemoglobin [ Time Frame: Preoperative 3 days and postoperative 1, 3, and 5 days ]The values of hemoglobin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
- The variation of C-reactive protein [ Time Frame: Preoperative 3 days and postoperative 1, 3, and 5 days ]The values of C-reactive protein IN milligram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
- The variation of prealbumin [ Time Frame: Preoperative 3 days and postoperative 1, 3, and 5 days ]The values of prealbumin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age from 18 to 75 years
- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
- clinical stage tumor 1-4a (cT1-4a), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
- No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations
- Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
- American Society of Anesthesiology score (ASA) class I, II, or III
- Written informed consent
Exclusion Criteria:
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
- History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
- Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
- History of other malignant disease within past five years
- History of previous neoadjuvant chemotherapy or radiotherapy
- History of unstable angina or myocardial infarction within past six months
- History of cerebrovascular accident within past six months
- History of continuous systematic administration of corticosteroids within one month
- Requirement of simultaneous surgery for other disease
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
- FEV1<50% of predicted values
- Diffuse; widespread; plastica
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050879
Locations
| China, Fujian | |
| Fujian Medical University Union Hospital | |
| Fuzhou, Fujian, China, 350000 | |
Sponsors and Collaborators
Fujian Medical University
Investigators
| Study Chair: | Changming Huang, Professor | Fujian Medical University Union Hospital |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Chang-Ming Huang, Prof., Clinical Professor, Fujian Medical University Union Hospital |
| ClinicalTrials.gov Identifier: | NCT03050879 |
| Other Study ID Numbers: |
FUGES-012 |
| First Posted: | February 13, 2017 Key Record Dates |
| Last Update Posted: | September 9, 2020 |
| Last Verified: | September 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Chang-Ming Huang, Prof., Fujian Medical University Union Hospital:
|
Stomach Neoplasms Indocyanine Green Tracer Laparoscopic Gastrectomy Lymph Node Dissection |
Additional relevant MeSH terms:
|
Stomach Neoplasms Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms |
Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |