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

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Recruiting
CT.gov ID
NCT05354856
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
24.7
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Indocyanine green
 Phase 4

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.

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°, 10 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.

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Only patients with resectable gastric cancer are included in the studyOnly patients with resectable gastric cancer are included in the study
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
The Effect of Chemoradiotherapy on Gastric Perfusion in Patients With Gastric Cancer.
Actual Study Start Date :
Mar 11, 2022
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Difference in gastric perfusion [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).

Secondary Outcome Measures

  1. Short term outcome [30 days after surgery]

    postoperative events and complications as graded by the Dindo-Clavien classification

  2. Short term outcome [30 days after surgery]

    Postoperative events as graded by the Comprehensive Complication Index

  3. Short term outcome [30 days after surgery]

    Length of hospital stay

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rigshospitalet Copenhagen Kbh Ø Denmark 2100

Sponsors and Collaborators

  • Rigshospitalet, Denmark

Investigators

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

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
JENS OSTERKAMP, MD, PhD-student, Principal Investigator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT05354856
Other Study ID Numbers:
  • H-20027060
First Posted:
May 2, 2022
Last Update Posted:
May 2, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Stomach Neoplasms

Study Results

No Results Posted as of May 2, 2022