NCT05369117Not yet recruiting
Application of Indocyanine Green Labeled Fluorescent Laparoscopy in Proximal Gastric Cancer
To Evaluate Whether the Clinical Efficacy of Laparoscopic Lymph Node Dissection With Indocyanine Green Tracer is Better Than Without Indocyanine Green Tracer
Source: ClinicalTrials.gov · Last updated 27 May 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Recently, laparoscopic gastrectomy has been gradually accepted by surgeons worldwide for gastric cancer treatment. Complete dissection of the lymph nodes and the establishment of the surgical margin are the most important considerations for curative gastric cancer surgery. Previous studies have demonstrated that indocyanine green (ICG)-traced laparoscopic gastrectomy significantly improves the completeness of lymph node dissection. However, it remains difficult to identify the tumor location intraoperatively for gastric cancers that are staged ≤T3. Here, the investigatorsinvestigated the feasibility of ICG fluorescence for lymph node mapping and tumor localization during totally laparoscopic distal gastrectomy.Preoperative and perioperative data from consecutive patients with gastric cancer who underwent a laparoscopic proximal gastrectomy were collected and analyzed. The investigators want to know if near-infrared fluorescence imaging with ICG can be successfully used in laparoscopic proximal gastrectomy, and if it contributes to both the completeness of D2 lymph node dissection and confirmation of the gastric transection line. The application of ICG labeled near infrared imaging fluorescence laparoscopic technology is still in the stage of exploration and experience accumulation, and it needs to be comprehensively evaluated through a large number of prospective randomized controlled studies.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 1016 (estimated)
- First submitted
- 25 Apr 2022
- Start date
- 31 May 2022
- Primary completion date
- 1 May 2027
- Lead sponsor
- Guangyong Zhang
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05369117
What you commit to
- Study type: Interventional
- Planned participants: 1016
- From 31 May 2022 to the primary completion date, 1 May 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Severe complications cannot tolerate surgery
- Neoadjuvant therapy has been implemented
- Refusing laparoscopic surgery
Other illness
- Suffering from severe mental illness
- Simultaneous surgical treatment of other diseases is required
- History of gastric surgery (including ESD/EMR for gastric cancer)
Other
- Tumors involving esophagus or duodenum were confirmed preoperatively
- Leather stomach
Who the study is looking for
- 18 years old \< age \< 75 years old
- The primary gastric lesion was pathologically diagnosed as proximal gastric adenocarcinoma by endoscopic biopsy (papillary adenocarcinoma PAP, tubular adenocarcinoma TUB, mucinous adenocarcinoma MUC, signed-ring cell carcinoma SIG, poorly differentiated adenocarcinoma POR)
- Preoperative clinical staging was CT1-4A, N-/+, and M0, according to AJCC-8th TNM tumor staging
- No distant metastasis was found in preoperative examination, and the tumor did not directly invade pancreas, spleen or other adjacent organs
- ECOG physical status score 0/1 before surgery Preoperative ASA score I-III
- (7) Informed consent of patients
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.