Infrapyloric and Greater Curvature Lymph Node Metastasis in Colon Cancer

• Sponsor: Shanghai Minimally Invasive Surgery Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03936530
• Collaborator: (none)
• Enrollment: 427
• Location: 1
• Anticipated Duration (Months): 77.4
• Patients Per Site Per Month: 5.5

Study Details

Study Description

Brief Summary

The infrapyloric (No.206) and greater curvature (No.204) lymph node metastasis in adenocarcinoma located at hepatic flexure and right half of transverse colon has not been well discribed and analysed. The aim of this study is to assess the rate of this lymph node metastasis and to reveal its prognostic value for colon cancer located at hepatic flexure and right half of transverse colon. Meanwhile, we can evaluate the safety and feasibility of this extented lymphadenectomy in right hemi-colectomy.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Neoplasm

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 427 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Infrapyloric (No.206) and Greater Curvature (No.204) Lymph Node Metastasis in Adenocarcinoma Located at Hepatic Flexure and Right Half of Transverse Colon
• Actual Study Start Date: Oct 20, 2019
• Anticipated Primary Completion Date: Apr 1, 2023
• Anticipated Study Completion Date: Apr 1, 2026

Outcome Measures

Primary Outcome Measures

1. metastasis rate [an average of 1 year]

   metastasis rate of infrapyloric (No.206) and greater curvature (No.204) lymph node

Secondary Outcome Measures

1. lymphadenectomy time [an average of 1 year]

   time of lymphadenectomy of infrapyloric (No.206) and greater curvature (No.204) lymph node

2. intraoperative complication [an average of 1 year]

   intraoperative complication

3. postoperative complication [an average of 1 year]

   postoperative complication

4. 3-year DFS [an average of 3 years]

   3-year disease free survival

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age between 18 and 75 years

• American Society of Anesthesiologists (ASA) score I to III

• A biopsy proven histological diagnosis of colorectal carcinoma

• tumor located at hepatic flexure and right half of transverse colon

• Undergoing right hemi-colectomy with extented lymphadenectomy of infrapyloric (No.206) and greater curvature (No.204) lymph node

• Preoperative staging cT2-4aN0M0 or cTanyN+M0

• Willing to participate and informed consent signed

Exclusion Criteria:

• Pregnant or lactating women

• Synchronous colorectal carcinoma

• History of colorectal cancer or other malignant tumors

• Clinical evidence of metastasis

• Preoperative staging cT1N0 or cT4bNany

• Emergency procedure

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ruijin hospital	Shanghai	Shanghai	China	200025

Sponsors and Collaborators

• Shanghai Minimally Invasive Surgery Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai Minimally Invasive Surgery Center
• ClinicalTrials.gov Identifier: NCT03936530
• Other Study ID Numbers: MISC- Infrapyloric LNM
• First Posted: May 3, 2019
• Last Update Posted: Apr 18, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Shanghai Minimally Invasive Surgery Center: colon adenocarcinoma; lymph node metastasis; right hemi-colectomy
• Additional relevant MeSH terms: Neoplasm Metastasis; Colorectal Neoplasms; Lymphatic Metastasis

Study Results

No Results Posted as of Apr 18, 2022