The Effect of Chemoradiotherapy on Gastric Perfusion in Patients With Gastric Cancer.

NCT05354856 | Terminated Phase 4 DMC

• 1 other identifier: H-20027060
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

A study from our group (Osterkamp et al. in preparation) used ICG to evaluate intraoperative changes in gastric perfusion when reducing the circulating blood volume by blood withdrawal in pigs. We saw a significant reduction in gastric perfusion with decreased blood volume, and this reduction of gastric perfusion was detectable with ICG. As data from a previous trial (PRESET phase 2 Protocol nr: H-15014904) has shown that chemotherapy decreases the circulating red blood cell volume in patients with gastroesophageal cancer, we wish to evaluate if standard care neoadjuvant chemotherapy also influences gastric perfusion. Gastric perfusion will be assessed during a screening laparoscopy (before chemotherapy) and then compared with a second assessment during gastric resection (after chemotherapy). The gastric perfusion will be measured using fluorescence-guided surgery with Indocyanine Green. Participants will be offered the opportunity to have their blood volume measured during the trial. This is not required in order to take part in the fluorescence angiography part of the study.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Difference in gastric perfusion

  The primary endpoint is the difference in gastric perfusion (obtained with q-ICG, using the slope of the fluorescence curve (as described by Nerup et al)) before and after neoadjuvant chemotherapy. A comparison of the gastric perfusion before and after chemotherapy will be performed using Friedman's test or a repeated measures ANOVA / linear mixed-effects depending on a non- or parametric nature of the data. A P-value \< 0.05 will be considered significant. Statistic evaluation will be performed using IBM SPSS Statistics © (v 22.0 SPSS Inc. Chicago, IL, USA).

  2 years

Secondary Outcomes (3)

• Short term outcome

  30 days after surgery

• Short term outcome

  30 days after surgery

• Short term outcome

  30 days after surgery

Study Arms (1)

ICG patient

EXPERIMENTAL

All patients included in the study will be injected with ICG (0.2 mg/kg bodyweight) to assess gastric perfusion.

Drug: Indocyanine green

Interventions

Indocyanine green DRUG

A bolus of ICG (0.2 mg/kg body weight) will be injected intravenously and flushed with 5 mL of saline. Gastric perfusion will subsequently be assessed along specific regions of interest (ROI) with q-ICG (quantitative perfusion assessments with ICG) to obtain baseline perfusion values.

ICG patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients (above 18 years) scheduled for planned open or robot-assisted resection of gastric cancer.

You may not qualify if:

• Allergy towards; iodine, indocyanine green or shellfish
• Severe liver insufficiency
• Thyrotoxicosis
• Nephropathy requiring dialysis
• Pregnancy or lactation
• Legally incompetent for any reason
• Disseminated disease or other that contraindicates curative surgery

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, KBH Ø, 2100, Denmark

Location

Related Publications (27)

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MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jens TF Osterkamp, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD-student, Principal Investigator

Model Details: Only patients with resectable gastric cancer are included in the study

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: May 2, 2022
• Study Start: March 11, 2022
• Primary Completion: December 29, 2023
• Study Completion: December 30, 2023
• Last Updated: May 2, 2024

Record last verified: 2024-04

Locations

DK (1)