NCT05618821

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for phase_2 gastric-cancer

Timeline
23mo left

Started Jun 2022

Longer than P75 for phase_2 gastric-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Jun 2022Apr 2028

First Submitted

Initial submission to the registry

June 3, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

June 3, 2022

Completed
6 months until next milestone

First Posted

Study publicly available on registry

November 16, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Expected
Last Updated

November 16, 2022

Status Verified

November 1, 2022

Enrollment Period

2.8 years

First QC Date

June 3, 2022

Last Update Submit

November 9, 2022

Conditions

Gastric Cancer

Keywords

Indocyanine Green TracerLaparoscopic GastrectomyRemnant Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Total Number of Retrieved Lymph Nodes

    Total Number of Retrieved Lymph Nodes

    30 days

Secondary Outcomes (14)

  • Lymph node noncompliance rate

    30 days

  • Relationship between fluorescent lymph nodes in the ICG group and total number of lymph nodes in the ICG group

    30 days

  • Relationship between fluorescent lymph nodes in the ICG group and positive lymph nodes in the ICG group (positive rate)

    30 days

  • Relationship between fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (false positive rate)

    30 days

  • Relationship between non-fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (negative rate)

    30 days

  • +9 more secondary outcomes

Study Arms (2)

ICG

EXPERIMENTAL

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

Drug: Indocyanine Green Tracer

Non-ICG

ACTIVE COMPARATOR

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

Drug: Indocyanine Green Tracer

Interventions

Indocyanine Green TracerDRUG

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

ICGNon-ICG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age from 18 to 75 years
  • 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

You may not qualify if:

  • Women during pregnancy or breast-feeding
  • Severe mental disorder
  • History of previous upper abdominal surgery (except for laparoscopic cholecystectomy and gastrectomy)
  • History of previous gastric surgery (including ESD/EMR for gastric cancer)
  • Rejection of laparoscopic resection
  • History of allergy to iodine agents
  • 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 the past six months
  • History of unstable angina or myocardial infarction within past six months
  • History of continuous systematic administration of corticosteroids within one month
  • Requirement of simultaneous surgery for another disease
  • Emergency surgery due to complications (bleeding, obstruction or perforation) caused by gastric cancer
  • FEV1\<50% of the predicted values
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350000, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Central Study Contacts

Hualong Zheng

CONTACT

+8618359190587291167038@qq.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 3, 2022

First Posted

November 16, 2022

Study Start

June 3, 2022

Primary Completion

April 1, 2025

Study Completion (Estimated)

April 1, 2028

Last Updated

November 16, 2022

Record last verified: 2022-11

Locations

CN(1)