Multicentric Study About Pathological Risk Factors for Lymph Node Metastasis in Malignant Colorectal Polyps

NCT03588416 | Unknown

• 1 other identifier: 1359CESC
• Study Type: observational
• Target: 615
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Lateral margin of healthy tissue (high risk: \<1mm and piecemeal polypectomy)
2. 2.Depth of submucosa invasion (high risk: \>1000 μM or sm2-sm3 for sessile polyps; Haggitt level 4 for pedunculated polyps)
3. 3.Vascular invasion (high risk: presence)
4. 4.Lymphatic invasion (high risk: presence)
5. 5.Tumor budding (high risk: presence)
6. 6.Tumor differentiation (high risk: grade G3-G4 or mucinous)

Conditions

Colorectal Cancer; Lymph Node Metastasis; Colorectal Polyp

Keywords

pT1; Polypectomy; Lymph node metastasis; Colorectal neoplasm

Outcome Measures

Primary Outcomes (2)

• Number of patients with lymph nodes metastasis in pT1 colorectal cancer

  The six pathological criteria will be tested as independent predictors of lymph node metastasis

  Enrollment

• Disease free survival in EG and SG and in patients with and without high risk factors

  24 months

Secondary Outcomes (5)

• Developing a clinical prognostic score for lymph node metastasis

  Enrollment

• Validating the clinical prognostic score as predictor of lymph node metastasis

  Enrollment

• Overall survival

  24 months

• Local and distal recurrence rate in EG and SG and in high risk patients and low risk patients

  24 months

• Sensitivity and specificity of diagnostic tests in detecting pathologic lymph nodes

  Enrollment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who underwent an endoscopic colorectal polypectomy with pathologic diagnosis of malignant polyp pT1

You may qualify if:

• All patients who underwent an endoscopic colorectal polypectomy for malignant polyp pT1

You may not qualify if:

• Age \< 18 years
• Gastrointestinal cancer previously diagnosticated or synchronous

Sponsors & Collaborators

• Dario Parini: lead

Study Sites (1)

Ospedale Santa Maria della Misericordia - ULSS 5 Polesana

Rovigo, 45100, Italy

RECRUITING

Related Publications (11)

• Mou 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 BACKGROUND

• Beaton 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 BACKGROUND

• Wada 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 BACKGROUND

• Haggitt 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 BACKGROUND

• Kikuchi 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 BACKGROUND

• Ueno 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 BACKGROUND

• van 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.

  PMID: 24183379 BACKGROUND

• Bartel MJ, Brahmbhatt BS, Wallace MB. Management of colorectal T1 carcinoma treated by endoscopic resection from the Western perspective. Dig Endosc. 2016 Apr;28(3):330-41. doi: 10.1111/den.12598. Epub 2016 Feb 16.

  PMID: 26718885 BACKGROUND

• Steele SR, Chang GJ, Hendren S, Weiser M, Irani J, Buie WD, Rafferty JF; Clinical Practice Guidelines Committee of the American Society of Colon and Rectal Surgeons. Practice Guideline for the Surveillance of Patients After Curative Treatment of Colon and Rectal Cancer. Dis Colon Rectum. 2015 Aug;58(8):713-25. doi: 10.1097/DCR.0000000000000410.

  PMID: 26163950 BACKGROUND

• von Elm E, Altman DG, Egger M, Pocock SJ, Gotzsche PC, Vandenbroucke JP; STROBE Initiative. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Epidemiology. 2007 Nov;18(6):800-4. doi: 10.1097/EDE.0b013e3181577654.

  PMID: 18049194 BACKGROUND

• Vandenbroucke JP, von Elm E, Altman DG, Gotzsche PC, Mulrow CD, Pocock SJ, Poole C, Schlesselman JJ, Egger M; STROBE Initiative. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration. Epidemiology. 2007 Nov;18(6):805-35. doi: 10.1097/EDE.0b013e3181577511.

  PMID: 18049195 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dario Parini

CONTACT

+39 0425 393559; dario.parini@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 28, 2018
• First Posted: July 17, 2018
• Study Start: March 1, 2018
• Primary Completion: February 29, 2020
• Study Completion: February 28, 2022
• Last Updated: September 28, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)