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

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

Tracking Information

• First Submitted Date: January 27, 2022
• First Posted Date: March 2, 2022
• Last Update Posted Date: March 14, 2023
• Actual Study Start Date: January 3, 2021
• Estimated Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 22, 2022)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 22, 2022)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Intraoperative Angiography Using ICG in Rectal Cancer Patients to Prevent Anastamotic Leak After Laparoscopic Anterior Resection of the Rectum
• Official Title: The Efficacy of Intraoperative ICG Angiography in Assuring Optimal Blood Supply to the Anastomosis in Rectal Cancer Patients Undergoing Laparoscopic Anterior Resection
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Care Provider); Primary Purpose: Treatment
• Condition: Rectal Cancer

Intervention

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

Study Arms

• Active Comparator: Intervention
  Intraoperative verdye green iv administration to visualize blood supply to the anastomosis
  Intervention: Drug: Verdye Green
• No Intervention: Control
  No administration of verdye green intraoperatively

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: February 22, 2022): 180
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2023
• Estimated Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• operative rectal cancer

Exclusion Criteria:

• known allergy toward indocyanic green

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Listed Location Countries: Poland

Administrative Information

• NCT Number: NCT05263336
• Other Study ID Numbers: ICG UJ Krakow
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Paweł Bogacki, Jagiellonian University
• Original Responsible Party: Same as current
• Current Study Sponsor: Jagiellonian University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Jagiellonian University
• Verification Date: March 2023