Indocyanine Green Lymphatic Mapping in Minimally Invasive Sigmoid and Rectal Cancer Surgery
NCT07916532, Not applicable, Completed, Jagiellonian University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Indocyanine Green Lymphatic Mapping in Minimally Invasive Sigmoid and Rectal Cancer Surgery | ClinicalTrials.gov |
| NCT number | NCT07916532 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 29 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Jagiellonian University | ClinicalTrials.gov |
| Conditions | Rectal Cancer, Sigmoid Colon Cancer | ClinicalTrials.gov |
| Interventions | Intraoperative ICG-Guided Lymphatic Mapping | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Proportion of Patients With Inadequate Lymphadenectomy | From surgery to final histopathological assessment (approximately 30 days after surgery). | The proportion of patients with inadequate lymphadenectomy, defined as retrieval of fewer than 12 lymph nodes in the surgical specimen, as determined by final histopathological examination. This outcome will be compared between patients undergoing minimally invasive colorectal cancer surgery with intraoperative indocyanine green-guided lymphatic mapping (ICG-LM) and a historical control group undergoing standard minimally invasive surgery without ICG-LM. | ClinicalTrials.gov |
| Secondary | Total Number of Retrieved Lymph Nodes | From surgery to final histopathological assessment (approximately 30 days after surgery). | The total number of lymph nodes retrieved from the surgical specimen, as determined by final histopathological examination. The number of retrieved lymph nodes will be compared between the ICG-guided lymphatic mapping group and the historical control group undergoing standard minimally invasive colorectal cancer surgery. | ClinicalTrials.gov |
| Secondary | Successful Lymphatic Mapping Rate | Intraoperatively, during the index surgical procedure. | The proportion of patients in the ICG-LM group in whom fluorescent lymphatic drainage pathways or lymph nodes were successfully visualized using near-infrared fluorescence imaging during minimally invasive colorectal cancer surgery. Mapping success will be expressed as the percentage of patients with successful visualization among all patients who received ICG. | ClinicalTrials.gov |
| Secondary | Aberrant Lymphatic Drainage Rate | Intraoperatively, during the index surgical procedure. | The proportion of patients with successfully visualized lymphatic drainage in whom ICG fluorescence imaging identified lymphatic drainage pathways outside the expected anatomical drainage territory. Aberrant drainage patterns will be assessed intraoperatively and reported as a percentage of patients with successful lymphatic mapping. | ClinicalTrials.gov |
| Secondary | Number of Additional Lymph Nodes Identified Through ICG Mapping | From surgery to final histopathological assessment (approximately 30 days after surgery). | The number of additional lymph nodes identified and retrieved based on intraoperative ICG fluorescence imaging, including lymph nodes located outside the expected lymphatic drainage territory. Retrieved lymph nodes will undergo histopathological examination to determine the presence or absence of metastatic involvement. | ClinicalTrials.gov |
| Secondary | Postoperative Complications | Within 30 days after surgery. | The incidence and severity of postoperative complications assessed using the Clavien-Dindo classification (grades I-V). Complication rates and severity will be compared between the ICG-LM group and the historical control group. | ClinicalTrials.gov |
| Secondary | Length of Postoperative Hospital Stay | From the date of surgery to hospital discharge (length of postoperative hospital stay, measured in days, on average, less than 30 days). | The number of days from the index surgical procedure to hospital discharge, compared between the ICG-LM group and the historical control group. | ClinicalTrials.gov |
| Secondary | Hospital Readmission Within 30 Days | Within 30 days after surgery. | The proportion of patients requiring unplanned hospital readmission within 30 days after the index surgical procedure. | ClinicalTrials.gov |
| Secondary | 30-Day Mortality | Within 30 days after surgery. | The proportion of patients who died from any cause within 30 days following the index surgical procedure. | ClinicalTrials.gov |
| Secondary | Reoperation Within 30 Days | Within 30 days after surgery. | The proportion of patients requiring an additional surgical intervention within 30 days after the index surgical procedure. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
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Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
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Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
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Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
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Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)