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NCT Number: NCT03936530

Infrapyloric and Greater Curvature Lymph Node Metastasis in Colon Cancer

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin hospital

Shanghai, Shanghai Municipality, 200025, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. metastasis rate

    Time frame: an average of 1 year

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

Secondary outcomes

  1. lymphadenectomy time

    Time frame: an average of 1 year

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

  2. intraoperative complication

    Time frame: an average of 1 year

    intraoperative complication

  3. postoperative complication

    Time frame: an average of 1 year

    postoperative complication

  4. 3-year DFS

    Time frame: an average of 3 years

    3-year disease free survival

Sponsors and collaborators

Lead sponsor

Shanghai Minimally Invasive Surgery Center

Other

Registry information

Official study title

Infrapyloric (No.206) and Greater Curvature (No.204) Lymph Node Metastasis in Adenocarcinoma Located at Hepatic Flexure and Right Half of Transverse Colon

Important dates

Study start
2019
Primary completion
2023
Study completion
2026
First posted
May 3, 2019
Registry last updated
Mar 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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