Clinical trialObsCompleted
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
- Outcome
- Finished, no results posted
- Phase
- Obs
- Status
- Completed
- Study type
- Observational
- Start
- February 1999
- Expected end
- August 2010
- Enrollment
- 115 participants
- Sites
- 1
- Primary outcomes
- Safety, as determined by the number of adverse events resulting from procedure; Ability of surgically defined sentinel lymph nodes to predict whether other lymph nodes are involved with the tumor
- Sponsor
- Other
- Results posted
- No
- Last update
- 30 May 2017
These are registry fields. A trial card, with population, design, endpoints and result direction each tied to a quote, is not in the data yet.
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Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
OBJECTIVES: Primary * Evaluate the safety and feasibility of visceral lymphatic mapping using isosulfan blue in patients with adenocarcinoma of the pancreas, colon, stomach, small bowel, or gallbladder. * Evaluate the ability of surgically defined sentinel lymph nodes to predict whether other lymph nodes in the basin are involved with the tumor in these patients. Secondary * Compare the results obtained from the sentinel lymph node (i.e., positive or negative for metastatic disease) with the results obtained from the other nodes in these patients. * Compare immunohistochemical analysis with standard analysis of the sentinel lymph nodes in these patients. * Evaluate the value of intraoperative touch prep analysis of sentinel lymph nodes in these patients. OUTLINE: This is a pilot study. During surgical resection of the primary tumor, patients receive isosulfan blue subcutaneously 5 minutes before undergoing sentinel lymph node identification/excision and radical lymphadenectomy. Tissue samples are analyzed by IHC for cytokeratins and CEA.
Papers 4
- Registry-listed results paperUse of sentinel node mapping for cancer of the colon: 'to map or not to map". DOI 10.1177/000313480607200707↗
- Registry-listed results paperIntraoperative imprint cytology for evaluation of sentinel lymph nodes from visceral malignancies. DOI 10.1016/s1091-255x(03)00069-6↗
- Registry-listed results paperLymphatic mapping for gastric adenocarcinoma. DOI 10.1177/000313480206801101↗
- Registry-listed results paperSentinel lymph node mapping for carcinoma of the colon: a pilot study. PMID 11261621↗
The registry lists these as results papers; in a hand check of 27 such links about 78% reported the trial’s results, so read the paper before treating it as the outcome.