Clinical trial · Observational
Multicentric Study About Pathological Risk Factors for Lymph Node Metastasis in Malignant Colorectal Polyps
Management of Malignant Colorectal Polyps (T1) After Endoscopic Polypectomy: Follow-up vs Surgery and Analysis of Pathological Risk Factors for Lymph Nodes Metastasis. A Retrospective and Prospective Multicentric Observational Study.
- 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)
Colorectal cancer screening showed an increased incidence of malignant colorectal polyps pT1 after endoscopic excision. Their management is not yet standardized, for the presence of histological features increasing early lymph node involvement. The literature has proposed several histopathological criteria, for which the risk of lymph node metastasis can vary (6-20%), but final data are not yet available. Aim 1.To collect data about patients undergoing an endoscopic polypectomy with histologic finding of pT1, retrospectively and prospectively, dividing both databases into two groups, endoscopic group (EG) and surgical group (SG) Aim 2. To analyze retrospectively which pathological criteria can increase the risk of lymph node metastasis and to elaborate a prognostic score for lymph node metastatic risk Aim 3. To verify prospectively the prognostic score capacity on predicting lymph node metastasis Aim 4. To calculate the disease free survival, overall survival, local recurrence rate and distal recurrence rate and verify if there is a difference between EG and SG According to literature, the most important histopathological criteria to establish the high risk of lymph node metastasis are: 1. Lateral margin of healthy tissue (high risk: \<1mm and piecemeal polypectomy) 2. Depth of submucosa invasion (high risk: \>1000 μM or sm2-sm3 for sessile polyps; Haggitt level 4 for pedunculated polyps) 3. Vascular invasion (high risk: presence) 4. Lymphatic invasion (high risk: presence) 5. Tumor budding (high risk: presence) 6. Tumor differentiation (high risk: grade G3-G4 or mucinous) A database will be used by all participating centres for collecting clinical and pathological data. All the analyses will be centralized by the PI. Uni-multivariate analyses will be conducted at the end of data collection for retrospective arm and at 2 years of follow-up for prospective arm. Impact: This study aimed to investigate pathological risk factors for lymph node metastasis in pT1 colorectal polyps after endoscopic polypectomy; their accurate identification could lead to improve their management, avoiding useless complementary surgery. Results could change clinical practice and reduce health-related costs.
Conditions
Conditions (3)
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 |
| Colorectal Polyp | — | UNRESOLVED | — |
| Lymph Node Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Number of patients with lymph nodes metastasis in pT1 colorectal cancer
- timeFrame
- Enrollment
- description
- The six pathological criteria will be tested as independent predictors of lymph node metastasis
- measure
- Disease free survival in EG and SG and in patients with and without high risk factors
- timeFrame
- 24 months
Secondary outcomes (5)
- measure
- Developing a clinical prognostic score for lymph node metastasis
- timeFrame
- Enrollment
- description
- The clinical prognostic score will be calculated from pathological criteria and clinical risk factors (i.e. sex, age, tumor localization, size)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All patients who underwent an endoscopic colorectal polypectomy for malignant polyp pT1 Exclusion Criteria: * Age \< 18 years * Gastrointestinal cancer previously diagnosticated or synchronous
References
Publications (11)
- BACKGROUNDMou S, Soetikno R, Shimoda T, Rouse R, Kaltenbach T. Pathologic predictive factors for lymph node metastasis in submucosal invasive (T1) colorectal cancer: a systematic review and meta-analysis. Surg Endosc. 2013 Aug;27(8):2692-703. doi: 10.1007/s00464-013-2835-5. Epub 2013 Feb 8. PMID 23392988
- BACKGROUNDBeaton C, Twine CP, Williams GL, Radcliffe AG. Systematic review and meta-analysis of histopathological factors influencing the risk of lymph node metastasis in early colorectal cancer. Colorectal Dis. 2013 Jul;15(7):788-97. doi: 10.1111/codi.12129. PMID 23331927
- BACKGROUNDWada H, Shiozawa M, Katayama K, Okamoto N, Miyagi Y, Rino Y, Masuda M, Akaike M. Systematic review and meta-analysis of histopathological predictive factors for lymph node metastasis in T1 colorectal cancer. J Gastroenterol. 2015 Jul;50(7):727-34. doi: 10.1007/s00535-015-1057-0. Epub 2015 Mar 1. PMID 25725617
- BACKGROUNDHaggitt RC, Glotzbach RE, Soffer EE, Wruble LD. Prognostic factors in colorectal carcinomas arising in adenomas: implications for lesions removed by endoscopic polypectomy. Gastroenterology. 1985 Aug;89(2):328-36. doi: 10.1016/0016-5085(85)90333-6. PMID 4007423
- BACKGROUNDKikuchi R, Takano M, Takagi K, Fujimoto N, Nozaki R, Fujiyoshi T, Uchida Y. Management of early invasive colorectal cancer. Risk of recurrence and clinical guidelines. Dis Colon Rectum. 1995 Dec;38(12):1286-95. doi: 10.1007/BF02049154. PMID 7497841
- BACKGROUNDUeno H, Murphy J, Jass JR, Mochizuki H, Talbot IC. Tumour 'budding' as an index to estimate the potential of aggressiveness in rectal cancer. Histopathology. 2002 Feb;40(2):127-32. doi: 10.1046/j.1365-2559.2002.01324.x. PMID 11952856
- BACKGROUNDvan de Velde CJ, Boelens PG, Borras JM, Coebergh JW, Cervantes A, Blomqvist L, Beets-Tan RG, van den Broek CB, Brown G, Van Cutsem E, Espin E, Haustermans K, Glimelius B, Iversen LH, van Krieken JH, Marijnen CA, Henning G, Gore-Booth J, Meldolesi E, Mroczkowski P, Nagtegaal I, Naredi P, Ortiz H, Pahlman L, Quirke P, Rodel C, Roth A, Rutten H, Schmoll HJ, Smith JJ, Tanis PJ, Taylor C, Wibe A, Wiggers T, Gambacorta MA, Aristei C, Valentini V. EURECCA colorectal: multidisciplinary management: European consensus conference colon & rectum. Eur J Cancer. 2014 Jan;50(1):1.e1-1.e34. doi: 10.1016/j.ejca.2013.06.048. Epub 2013 Oct 31.