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

December 11, 2023 updated by: JENS OSTERKAMP, Rigshospitalet, Denmark

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Screening Laparoscopy:

As part of the standard care for gastric cancer, all patients undergo a screening laparoscopy before entering neoadjuvant chemotherapy. The procedure is performed to detect overt metastases not detected on the CT/PET-CT scans. First, the patient is placed under a standardized general anesthesia, and the laparoscopic set-up is completed. After anesthesia a peripheral arterial catheter will be placed in order acquire reading of cardia output and stroke volume. The patient will then be fluid optimized using a standardized stroke volume (SV) optimization algorithm. The abdomen is inspected visually for signs of metastatic disease. The small bowel is then manipulated, allowing for visualization of the stomach. 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 to obtain baseline perfusion values.

As a substudy, 10 patients will have two measurements with ICG during the screening laparoscopy, one befor eand one after fluid optimization. These patients will receive an ICG dose of 0.1 mg/kg body weight per measurement, totalling 0.2 mg/kg after the two measurements.

Resection of gastric cancer:

The patient is placed under general anesthesia and after the stomach is visualized through surgical incision, a bolus of ICG (0.2 mg/kg body weight) will be injected intravenously and flushed with 5 mL of saline. The ROIs (the same ROIs as described in 3.7.1) will then be assessed with q-ICG. The anesthetic protocol will up to this point match that of the setting during the screening laparoscopy.

Fluorescence angiography:

During the screening laparoscopy, a laparoscope (telescope 30°, 5 mm, Arthrex Danmark A/S) will be connected to a camera system (Synergy, Arthrex Danmark A/S) and a light-source (Synergy Laser Light Source, Arthrex Danmark A/S) will supply the excitatory light and record the ICG angiography. The laparoscope will be fixed in a mechanical holding arm 10 cm from the tissue of interest, ensuring a stable position throughout the experiment.

Measuring of blood volume:

Hemoglobin mass (Hbmass) will be determined using a carbon monoxide (CO) rebreathing technique with a typical error of 1.0 %, as previously described (25). In brief, all individuals will rest for 20 min in the supine position before each measurement. During this time, a catheter will be inserted in an antecubital vein. Thereafter, 2 ml of blood will be sampled and analyzed immediately in triplicates for percentage carboxyhaemoglobin (% HbCO) and [Hb] (ABL800, Radiometer, Denmark). Subsequently, individuals will breathe 100 % O2 for 4 min to flush nitrogen from the airways. Then, a bolus of 1.5 ml kg-1 of 99.997 % chemically pure CO (CO N47, Air Liquide, France) will be administrated into the breathing circuit. Individuals will re-breath this gas mixture for 10 min. An additional 2 ml blood sample will be obtained and analyzed in triplicates. The change in % HbCO will be used to calculate Hbmass. Total RBCV, PV and BV will be derived from measures of Hbmass and hematocrit29.

The collected blood samples will not be stored after the measurement.

Statistics:

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).

Study Type

Interventional

Enrollment (Estimated)

11

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
    • Kbh Ø
      • Copenhagen, Kbh Ø, Denmark, 2100
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ICG patient
All patients included in the study will be injected with ICG (0.2 mg/kg bodyweight) to assess gastric perfusion.
Drug: Indocyanine green
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in gastric perfusion
Time Frame: 2 years

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short term outcome
Time Frame: 30 days after surgery
postoperative events and complications as graded by the Dindo-Clavien classification
30 days after surgery
Short term outcome
Time Frame: 30 days after surgery
Postoperative events as graded by the Comprehensive Complication Index
30 days after surgery
Short term outcome
Time Frame: 30 days after surgery
Length of hospital stay
30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Jens TF Osterkamp, MD, Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2022

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

February 15, 2022

First Submitted That Met QC Criteria

April 26, 2022

First Posted (Actual)

May 2, 2022

Study Record Updates

Last Update Posted (Estimated)

December 12, 2023

Last Update Submitted That Met QC Criteria

December 11, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-20027060

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastric Cancer

Clinical Trials on Indocyanine green

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe