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Comparison of Low and High Ligation With Apical Lymph Node Dissection in the Laparoscopy Rectal Cancer (PLAND)

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ClinicalTrials.gov Identifier: NCT03498885
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
WEIDONG LIU，MD, Xiangya Hospital of Central South University

Tracking Information
First Submitted Date  ICMJE January 16, 2018
First Posted Date  ICMJE April 17, 2018
Last Update Posted Date September 9, 2020
Actual Study Start Date  ICMJE January 1, 2018
Estimated Primary Completion Date December 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2018)		 Anastomotic leakage [ Time Frame: 3 months ]
Anastomosis leakage rate after surgery, acute or chronic
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2018)
  • proximal bowel necrosis [ Time Frame: 3 months ]
    Proximal bowel necrosis rate after surgery, acute or chronic
  • proximal bowel stenosis [ Time Frame: 3 months ]
    Proximal bowel stenosis rate after surgery, acute or chronic
  • Characteristics of the division branches of the inferior mesenteric artery in Chinese people [ Time Frame: 1-2 days ]
    e.g.,The distance from the left colon artery to the root of inferior mesenteric artery(cm).
  • Apical Lymph Nodes Positive Rate [ Time Frame: 14 days ]
    Apical Lymph Nodes Positive Rate
  • Conversion rate to laparotomy [ Time Frame: 5-years ]
    Conversion rate to laparotomy
  • Complications of defunctioning stoma [ Time Frame: 3 months ]
    Complications of defunctioning stoma
  • Early postoperative complications: Anastomotic bleeding, etc. [ Time Frame: 30 days ]
    Early postoperative complications: Anastomotic bleeding, etc.
  • Anastomosis stenosis rate after surgery [ Time Frame: 30 days ]
    Anastomosis stenosis rate after surgery
  • Mortality rate in 3 months after surgery [ Time Frame: 3 months ]
    Mortality rate in 3 months after surgery
  • Life quality [ Time Frame: 5-years ]
    Life quality is measured by questionnaire(EORTC QLQ-C30 (version 3)).
  • Micturition function scoring [ Time Frame: 3 months ]
    Micturition function is measured by questionnaire(IPSS).
  • Sexual function scoring [ Time Frame: 3 months ]
    Sexual function is measured by questionnaire(The IIEF-5 questionnaire).
  • 5-years overall survival rate [ Time Frame: 5-years ]
    5-years overall survival rate
  • 5-years disease free survival rate [ Time Frame: 5-years ]
    5-years disease free survival rate
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Low and High Ligation With Apical Lymph Node Dissection in the Laparoscopy Rectal Cancer
Official Title  ICMJE Preservation of the Left Colic Artery With Apical Lymph Node Dissection in Laparoscopic Rectal Cancer Surgery
Brief Summary The purpose of this study is to explore the different impacts of high and low ligation in laparoscopic rectal interior resection on postoperative anastomotic leakage and proximal bowel necrosis and stenosis, as well as the quality of life and long-term survival. In the anterior resection of rectum, the section level of inferior mesenteric artery (IMA) is still a controversial subject between the advocates of high and low ligation. The low ligation is defined as the IMA is ligated below the origin of the left colic artery while the high ligation refers to the IMA is ligated at its origin from the aorta. Nowadays the spread of laparoscopy has encouraged more frequent execution of the high ligation, which appears easier to achieve than the low ligation and also with the advantage of lower anastomosis traction but with the disadvantage of worse vascularization of the stumps as well.
Detailed Description

It has long been debated that whether to tie off the inferior mesenteric artery (IMA) at its origin or just below the origin of the left colic artery (LCA) of the anterior resection of the rectum. Thus far, no clear consensus has been achieved, and the level of arterial ligation still varies among institutions and patients. In the previous studies, high or low ligation takes advantage on both sides. However, there are still some researches that have demonstrated no significant difference had been found in the incidence of anastomotic leakage and other complications between the high and low ligation groups. Therefore, to provide a clear and definite answer to surgeons of how they should deal with the IMA in laparoscopy rectal surgery. We plan to explore the impacts of high and low tie in laparoscopic anterior rectal resection on postoperative anastomotic leakage and proximal bowel necrosis and stenosis, as well as the quality of life and long-term survival by prospective and multi-center clinical trial.

Surgery will be described as follows:

For low ligation group:

  1. Laparoscopic surgery is performed. Tie the sigmoid artery and superior rectal artery, LCA is preserved. Lymphadenectomy to Apical lymph nodes is performed. Strip the beginning part of upper rectal artery and the first sigmoid artery. Strip the left colic artery until reaching the inferior mesenteric vein (IMV). The abdominal aorta lymph nodes need to be cleaned if it's been spotted swollen.
  2. Vascular ligation level: Left colonic artery needs to be preserved, the rectal artery and the first sigmoid artery are ligated. Ligate inferior mesenteric artery below left colonic artery come across the inferior mesenteric vein level.

For high ligation groups:

Laparoscopic surgery is performed. The IMA is ligated and divided at 2 cm. from its origin. Dissect the adipose tissue and lymph nodes around IMA. The inferior mesenteric vein (IMV) is divided and ligated below the duodenal margin. The abdominal aorta lymph nodes need to be cleaned if it's been spotted swollen. For both groups Total Mesolectal Excision (TME) is performed according to the principles of Heald.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Procedure： Low ligation with apical lymph node dissection

Procedure： High ligation with apical lymph node dissection

Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Rectal Cancer
Intervention  ICMJE
  • Procedure: Low ligation
    Left colic artery (LCA) is identified, Tie the sigmoid artery and superior rectal artery, Apical lymph node dissection with the left colic artery preservation is performed.
    Other Name: LL
  • Procedure: High ligation
    The IMA is ligated and divided at 2 cm from its origin. Apicallymph nodes dissection is performed.
    Other Name: HL
Study Arms  ICMJE
  • Experimental: Low ligation
    Left colic artery (LCA) is identified, tie the sigmoid artery and superior rectal artery,Apical lymph node dissection with the left colic artery preservation is performed.
    Intervention: Procedure: Low ligation
  • Active Comparator: High ligation
    The IMA is ligated and divided at 2 cm from its origin. Apical lymph nodes dissection is performed.
    Intervention: Procedure: High ligation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 7, 2018)		 466
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2025
Estimated Primary Completion Date December 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 Years to 75 Years (Adult, Senior).
  • Colonoscopy and pathology shows rectal or sigmoid adenocarcinoma.
  • Tumor located at 4-15 cm from the dentate line.
  • The clinical staging of tumor by MRI within T1-4a when tumor Above the peritoneum and T3N0-2 when tumor below the peritoneum.
  • Receive or not receive neoadjuvant chemotherapy based on 5-fluorouracil before surgery and radical resection is available after neoadjuvant chemotherapy.
  • Anus-saving operation is available.
  • ASA class: I-III.
  • Well tolerate to general anesthesia.
  • ECOG score: 0-1.
  • Patients - can understand and are willing to take part in the clinical trial.

Exclusion Criteria:

  • Severe cardiovascular disease, uncontrollable infection or other severe complications.
  • Severe mental illness.
  • Suffer with other carcinoma simultaneously or sequentially in 5 years.
  • Familial polyposis coli or Multiple -colorectal tumor.
  • History of abdominal surgery and with severe abdominal adhesions.
  • Combine with acute intestinal obstruction, intestinal bleeding, intestinal perforation and emergency surgery is needed.
  • Multiple organs resection surgery is needed.
  • Abdominoperineal resection need to be performed.
  • ASA class: IV to V.
  • Pregnant, suckling period or reject to birth control.
  • Patient who unable to go through the clinical trial because of familial,social or religious factors.
  • Refuse to take part in the trial.
  • Patients without an informed consent.
  • Non-compliant patient
  • The patient or their family members want to withdraw from the clinical trial.
  • Loss to follow-up
  • Researchers think the participants need to withdraw from the clinical trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ting Zou, MD 0086-15874865802 zouting218@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03498885
Other Study ID Numbers  ICMJE CCRS-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: we would like to share our data.
Supporting Materials: Study Protocol
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Around 2025
Access Criteria: Someone who has the same or similar research could contact us at davidcsu@foxmail.com
Current Responsible Party WEIDONG LIU，MD, Xiangya Hospital of Central South University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE WEIDONG LIU，MD
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wei dong Liu, MD Xiangya Hospital of Central South University
Study Director: Xi Xie, MD Xiangya Hospital of Central South University
PRS Account Xiangya Hospital of Central South University
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP