Clinical trial · Observational
Visceral Lymphatic Mapping Using Isosulfan Blue in Patients With Cancer of the Pancreas, Colon, Stomach, Small Intestine, or Gallbladder
Visceral Lymphatic Mapping Project: A Pilot Study
NCT00489515CI-TRIAL-00027864completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Diagnostic procedures, such as visceral lymphatic mapping using isosulfan blue, may help find cancer of the pancreas, colon, stomach, small intestine, or gallbladder and find out how far the disease has spread. PURPOSE: This clinical trial is studying the side effects and how well visceral lymphatic mapping using isosulfan blue works in patients with cancer of the pancreas, colon, stomach, small intestine, or gallbladder.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Gallbladder Cancer | Malignant Gallbladder Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Small Intestine Cancer | Small Intestinal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- patients with gastrointestinal cancer scheduled for surgery
Primary outcomes (2)
- measure
- Safety, as determined by the number of adverse events resulting from procedure
- timeFrame
- 1 week
- description
- Safety will be assessed by documenting the number of adverse clinical events resulting from the procedure
- measure
- Ability of surgically defined sentinel lymph nodes to predict whether other lymph nodes are involved with the tumor
- timeFrame
- 1 week
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of adenocarcinoma of 1 of the following sites: * Pancreas * Stomach * Colon * Small bowel * Gallbladder * Patients with highly suspicious pancreatic lesions without definitive tissue biopsy are eligible * No prior uncontrolled visceral malignancy PATIENT CHARACTERISTICS: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No medical comorbidities that would preclude definitive resection * No known allergies to isosulfan blue PRIOR CONCURRENT THERAPY: * Not specified
References
Publications (4)
- RESULTHundley JC, Shen P, Shiver SA, Geisinger KR, Levine EA. Lymphatic mapping for gastric adenocarcinoma. Am Surg. 2002 Nov;68(11):931-5. PMID 12455783
- RESULTLevine EA, Shen P, Shiver SA, Waters G, Brant A, Geisenger KR. Intraoperative imprint cytology for evaluation of sentinel lymph nodes from visceral malignancies. J Gastrointest Surg. 2003 Jul-Aug;7(5):687-91. doi: 10.1016/s1091-255x(03)00069-6. PMID 12850683
- RESULTWaters GS, Geisinger KR, Garske DD, Loggie BW, Levine EA. Sentinel lymph node mapping for carcinoma of the colon: a pilot study. Am Surg. 2000 Oct;66(10):943-5; discussion 945-6. PMID 11261621
- RESULTThomas KA, Lechner J, Shen P, Waters GS, Geisinger KR, Levine EA. Use of sentinel node mapping for cancer of the colon: 'to map or not to map". Am Surg. 2006 Jul;72(7):606-11; discussion 611-2. PMID 16875082