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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Rectal Cancer Procedure: Low ligation Procedure: High ligation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 466 participants
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
Official Title: Preservation of the Left Colic Artery With Apical Lymph Node Dissection in Laparoscopic Rectal Cancer Surgery
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2025
Arms and Interventions
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Arm Intervention/treatment
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.
 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
Active Comparator: High ligation
The IMA is ligated and divided at 2 cm from its origin. Apical lymph nodes dissection is performed.
 Procedure: High ligation
The IMA is ligated and divided at 2 cm from its origin. Apicallymph nodes dissection is performed.
Other Name: HL


Outcome Measures
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Primary Outcome Measures :
  1. Anastomotic leakage [ Time Frame: 3 months ]
    Anastomosis leakage rate after surgery, acute or chronic


Secondary Outcome Measures :
  1. proximal bowel necrosis [ Time Frame: 3 months ]
    Proximal bowel necrosis rate after surgery, acute or chronic

  2. proximal bowel stenosis [ Time Frame: 3 months ]
    Proximal bowel stenosis rate after surgery, acute or chronic

  3. 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).

  4. Apical Lymph Nodes Positive Rate [ Time Frame: 14 days ]
    Apical Lymph Nodes Positive Rate

  5. Conversion rate to laparotomy [ Time Frame: 5-years ]
    Conversion rate to laparotomy

  6. Complications of defunctioning stoma [ Time Frame: 3 months ]
    Complications of defunctioning stoma

  7. Early postoperative complications: Anastomotic bleeding, etc. [ Time Frame: 30 days ]
    Early postoperative complications: Anastomotic bleeding, etc.

  8. Anastomosis stenosis rate after surgery [ Time Frame: 30 days ]
    Anastomosis stenosis rate after surgery

  9. Mortality rate in 3 months after surgery [ Time Frame: 3 months ]
    Mortality rate in 3 months after surgery

  10. Life quality [ Time Frame: 5-years ]
    Life quality is measured by questionnaire(EORTC QLQ-C30 (version 3)).

  11. Micturition function scoring [ Time Frame: 3 months ]
    Micturition function is measured by questionnaire(IPSS).

  12. Sexual function scoring [ Time Frame: 3 months ]
    Sexual function is measured by questionnaire(The IIEF-5 questionnaire).

  13. 5-years overall survival rate [ Time Frame: 5-years ]
    5-years overall survival rate

  14. 5-years disease free survival rate [ Time Frame: 5-years ]
    5-years disease free survival rate


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03498885


Contacts
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Contact: Ting Zou, MD 0086-15874865802 zouting218@163.com

Locations
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China, Hunan
Xiangya Hospital of Central South University Recruiting
Changsha, Hunan, China, 410000
Contact: Liu wei dong, doctor    0086-13873124855    davidcsu@foxmail.com   
Sponsors and Collaborators
WEIDONG LIU，MD
Investigators
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Principal Investigator: Wei dong Liu, MD Xiangya Hospital of Central South University
Study Director: Xi Xie, MD Xiangya Hospital of Central South University
More Information
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Publications:

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Responsible Party: WEIDONG LIU，MD, Head of Department of General Surgery, Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT03498885    
Other Study ID Numbers: CCRS-1
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: we would like to share our data.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Around 2025
Access Criteria: Someone who has the same or similar research could contact us at davidcsu@foxmail.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by WEIDONG LIU，MD, Xiangya Hospital of Central South University:
Rectal Cancer
inferior mesenteric artery
Laparoscopic
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases