Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Remnant Gastric Cancer

NCT ID: NCT05618821

Last Updated: 2022-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-03

Study Completion Date

2028-04-01

Brief Summary

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Patients with resectable remnant gastric cancer were selected as study subjects to investigate the safety, efficacy, and feasibility of ICG near-infrared imaging tracing in guiding laparoscopic lymph node dissection for remnant gastric cancer by comparing injection ICG group and non-injection ICG group.

Detailed Description

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Indocyanine Green Tracer is often applied in surgery for gastric cancer. Its application in laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer 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 remnant gastric cancer. On the basis of more than 300 cases of laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer, 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 remnant gastric cancer, to guid the scope of laparoscopic lymph node dissection for remnant gastric cancer.

Conditions

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Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ICG

Laparoscopic gastrectomy Group with the use of near-infrared imaging (ICG group)

Group Type EXPERIMENTAL

Indocyanine Green Tracer

Intervention Type DRUG

Laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer using Indocyanine Green Tracer

Non-ICG

Laparoscopic gastrectomy Group without the use of near-infrared imaging (Non-ICG group)

Group Type ACTIVE_COMPARATOR

Indocyanine Green Tracer

Intervention Type DRUG

Laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer using Indocyanine Green Tracer

Interventions

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Indocyanine Green Tracer

Laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer using Indocyanine Green Tracer

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age from 18 to 75 years
2. Remnant gastric cancer (cT1-4a, N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition)

(4) No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations (5) Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale (6) ASA (American Society of Anesthesiology) class I to III (7) Written informed consent

Exclusion Criteria

1. Women during pregnancy or breast-feeding
2. Severe mental disorder
3. History of previous upper abdominal surgery (except for laparoscopic cholecystectomy and gastrectomy)
4. History of previous gastric surgery (including ESD/EMR for gastric cancer)
5. Rejection of laparoscopic resection
6. History of allergy to iodine agents
7. Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
8. History of other malignant disease within past five years
9. History of previous neoadjuvant chemotherapy or radiotherapy
10. History of unstable angina or myocardial infarction within the past six months
11. History of unstable angina or myocardial infarction within past six months
12. History of continuous systematic administration of corticosteroids within one month
13. Requirement of simultaneous surgery for another disease
14. Emergency surgery due to complications (bleeding, obstruction or perforation) caused by gastric cancer
15. FEV1\<50% of the predicted values
16. Linitis plastica, Widespread
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Chang-Ming Huang, Prof.

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hualong Zheng

Role: CONTACT

+8618359190587

Facility Contacts

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Hualong Zheng

Role: primary

+8618359190587

Other Identifiers

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FUGES-027

Identifier Type: -

Identifier Source: org_study_id

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