Clinical trial · Interventional
Carnoy's Solution Versus Formalin in Rectal and Gastric Cancer Specimens Following: a Randomized Trial
Lymph Node Yield After Specimen Fixation With Carnoy's Solution and 10% Neutral Buffered Formaldehyde in Patients With Colorectal Cancer or Gastric Adenocarcinoma Specimens: a Randomized Trial
NCT02629315CI-TRIAL-00046115completedN/AClinicalTrials.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)
This study evaluates the number of lymph nodes dissected in specimens following fixation with 10% neutral buffered formaldehyde or Carnoy's solution. Specimens were randomized for fixation in each solution.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Adenocarcinoma | Gastric Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 10% neutral buffered formaldehyde | Other | — | UNRESOLVED |
| Carnoy's solution | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 10% neutral buffered formaldehyde
- description
- Specimens will be fixed for 24-48hours in 10% neutral buffered formaldehyde and then dissected for lymph nodes.
- interventionNames
- Other: 10% neutral buffered formaldehyde
- type
- EXPERIMENTAL
- label
- Carnoy's solution
- description
- Specimens will be fixed for 24-48hours in Carno'ys solution and then dissected for lymph nodes.
- interventionNames
- Other: Carnoy's solution
Primary outcomes (1)
- measure
- Lymph node yield
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria - Rectal Cancer: * Long course neoadjuvant chemoradiation * Low anterior resection with total mesorectal excision Inclusion Criteria - Colon Cancer: \- Rectosigmoidectomy Inclusion Criteria - Gastric Cancer: * Gastric adenocarcinoma * Subtotal gastrectomy * D2 lymphadenectomy Exclusion Criteria - Rectal Cancer: * Previous surgery * Incomplete neoadjuvant chemoradiation * Refuse to sign the informed consent * T4b and/or Multivisceral resection Exclusion Criteria - Colon Cancer: * Previous surgery * Neoadjuvant chemoradiation * Refuse to sign the informed consent * T4b and/or Multivisceral resection Exclusion Criteria - Gastric Cancer: * Distant metastasis * Previous upper abdomen radiotherapy * Previous surgery over stomach or omentum * Refuse to sign the informed consent
References
Publications (7)
- BACKGROUNDDias AR, Pereira MA, Mello ES, Zilberstein B, Cecconello I, Ribeiro Junior U. Carnoy's solution increases the number of examined lymph nodes following gastrectomy for adenocarcinoma: a randomized trial. Gastric Cancer. 2016 Jan;19(1):136-42. doi: 10.1007/s10120-014-0443-2. Epub 2014 Nov 20. PMID 25410474
- BACKGROUNDPereira MA, Dias AR, Faraj SF, Cirqueira Cdos S, Tomitao MT, Nahas SC, Ribeiro U Jr, de Mello ES. Carnoy's solution is an adequate tissue fixative for routine surgical pathology, preserving cell morphology and molecular integrity. Histopathology. 2015 Feb;66(3):388-97. doi: 10.1111/his.12532. Epub 2014 Nov 10. PMID 25307771
- BACKGROUNDLuz DA, Ribeiro U Jr, Chassot C, Collet E Silva Fde S, Cecconello I, Corbett CE. Carnoy's solution enhances lymph node detection: an anatomical dissection study in cadavers. Histopathology. 2008 Dec;53(6):740-2. doi: 10.1111/j.1365-2559.2008.03148.x. No abstract available. PMID 19076686
- BACKGROUNDDuldulao M, Booth C, Denham L, Choi A, Friedman G, Kazanjian K. Alcohol fat clearing increases lymph node yield after surgery for colorectal cancer. Am Surg. 2014 Oct;80(10):1054-8. PMID 25264659
- BACKGROUNDScabini S, Montecucco F, Nencioni A, Zoppoli G, Sartini M, Rimini E, Massobrio A, De Marini L, Poggi A, Boaretto R, Romairone E, Ballestrero A, Ferrando V. The effect of preoperative chemoradiotherapy on lymph nodes harvested in TME for rectal cancer. World J Surg Oncol. 2013 Nov 18;11:292. doi: 10.1186/1477-7819-11-292. PMID 24246069
- BACKGROUNDDias AR, Pereira MA, de Mello ES, Nahas SC, Cecconello I, Ribeiro U Jr. Lymph Node Yield After Neoadjuvant Chemoradiotherapy in Rectal Cancer Specimens: A Randomized Trial Comparing Two Fixatives. Dis Colon Rectum. 2018 Aug;61(8):888-896. doi: 10.1097/DCR.0000000000001097. PMID 29944580
- Dias AR, Pereira MA, Mello ES, Cecconello I, Ribeiro-Jr U, Nahas SC. CARNOY'S SOLUTION INCREASES LYMPH NODES COUNT IN COLON CANCER SPECIMENS WHEN COMPARED TO FORMALIN FIXATION: A RANDOMIZED TRIAL. Arq Bras Cir Dig. 2022 Jun 17;35:e1656. doi: 10.1590/0102-672020210002e1656. eCollection 2022.