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Intraoperative Angiography Using ICG in Rectal Cancer Patients to Prevent Anastamotic Leak After Laparoscopic Anterior Resection of the Rectum

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ClinicalTrials.gov Identifier: NCT05263336
Recruitment Status : Recruiting
First Posted : March 2, 2022
Last Update Posted : March 14, 2023
Sponsor:
Information provided by (Responsible Party):
Paweł Bogacki, Jagiellonian University

Study Description
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Brief Summary:
The study enrols patients with operative rectal cancer qualified for laparoscopic anterior resection. Patients are given first dose of indocyanine green iv intraoperatively (ICG) before choosing the appropriate site of the anastomosis, and the second dose after performing the anastomosis to confirm adequate blood supply to the anastomotis. The main outcome assessed is the frequency o anastomotic leak in comparison to the group of patients that do not undergo intraoperative ICG angiography.

Condition or disease Intervention/treatment Phase
Rectal Cancer Drug: Verdye Green Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: The Efficacy of Intraoperative ICG Angiography in Assuring Optimal Blood Supply to the Anastomosis in Rectal Cancer Patients Undergoing Laparoscopic Anterior Resection
Actual Study Start Date : January 3, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Intervention
Intraoperative verdye green iv administration to visualize blood supply to the anastomosis
 Drug: Verdye Green
intraoperative iv application of indocyanic green for visualisation of blood supply to the anastomosis after rectal cancer recection
Other Name: Indocyianic Green
No Intervention: Control
No administration of verdye green intraoperatively


Outcome Measures
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Primary Outcome Measures :
  1. Anastomotic leak [ Time Frame: Up to two weeks post surgery ]
    Leakage in the anastomotic line defined as peritonitis requiring relaparotomy resulting from stool leakage from the anastomosis line


Secondary Outcome Measures :
  1. Postsurgical Ileus [ Time Frame: Up to 10 days post surgery ]
    Prolonged postsurgical ileus defined as no oral diet toleration, nausea, vomiting, no gas or stool passage lasting more than 4 days post surgery


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • operative rectal cancer

Exclusion Criteria:

  • known allergy toward indocyanic green
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05263336


Locations
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Poland
St John Grande Hospital Recruiting
Kraków, Lesser Poland, Poland, 31-060
Contact: Pawel Bogacki    0048667177677    pawel.bogacki@uj.edu.pl   
Sponsors and Collaborators
Jagiellonian University
More Information
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Responsible Party: Paweł Bogacki, Principle Investigator, Jagiellonian University
ClinicalTrials.gov Identifier: NCT05263336    
Other Study ID Numbers: ICG UJ Krakow
First Posted: March 2, 2022    Key Record Dates
Last Update Posted: March 14, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Paweł Bogacki, Jagiellonian University:
rectal cancer
laparoscopic anterior resection
intraoperative angiography
ICG
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases