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

Primary Purpose

Rectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Low ligation
High ligation
Sponsored by
WEIDONG LIU,MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring Rectal Cancer, inferior mesenteric artery, Laparoscopic

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xiangya Hospital of Central South UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low ligation

High ligation

Arm Description

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.

The IMA is ligated and divided at 2 cm from its origin. Apical lymph nodes dissection is performed.

Outcomes

Primary Outcome Measures

Anastomotic leakage
Anastomosis leakage rate after surgery, acute or chronic

Secondary Outcome Measures

proximal bowel necrosis
Proximal bowel necrosis rate after surgery, acute or chronic
proximal bowel stenosis
Proximal bowel stenosis rate after surgery, acute or chronic
Characteristics of the division branches of the inferior mesenteric artery in Chinese people
e.g.,The distance from the left colon artery to the root of inferior mesenteric artery(cm).
Apical Lymph Nodes Positive Rate
Apical Lymph Nodes Positive Rate
Conversion rate to laparotomy
Conversion rate to laparotomy
Complications of defunctioning stoma
Complications of defunctioning stoma
Early postoperative complications: Anastomotic bleeding, etc.
Early postoperative complications: Anastomotic bleeding, etc.
Anastomosis stenosis rate after surgery
Anastomosis stenosis rate after surgery
Mortality rate in 3 months after surgery
Mortality rate in 3 months after surgery
Life quality
Life quality is measured by questionnaire(EORTC QLQ-C30 (version 3)).
Micturition function scoring
Micturition function is measured by questionnaire(IPSS).
Sexual function scoring
Sexual function is measured by questionnaire(The IIEF-5 questionnaire).
5-years overall survival rate
5-years overall survival rate
5-years disease free survival rate
5-years disease free survival rate

Full Information

First Posted
January 16, 2018
Last Updated
September 7, 2020
Sponsor
WEIDONG LIU,MD
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1. Study Identification

Unique Protocol Identification Number
NCT03498885
Brief Title
Comparison of Low and High Ligation With Apical Lymph Node Dissection in the Laparoscopy Rectal Cancer
Acronym
PLAND
Official Title
Preservation of the Left Colic Artery With Apical Lymph Node Dissection in Laparoscopic Rectal Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
WEIDONG LIU,MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
Rectal Cancer, inferior mesenteric artery, Laparoscopic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Procedure: Low ligation with apical lymph node dissection Procedure: High ligation with apical lymph node dissection
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
466 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low ligation
Arm Type
Experimental
Arm Description
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.
Arm Title
High ligation
Arm Type
Active Comparator
Arm Description
The IMA is ligated and divided at 2 cm from its origin. Apical lymph nodes dissection is performed.
Intervention Type
Procedure
Intervention Name(s)
Low ligation
Other Intervention Name(s)
LL
Intervention Description
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 Type
Procedure
Intervention Name(s)
High ligation
Other Intervention Name(s)
HL
Intervention Description
The IMA is ligated and divided at 2 cm from its origin. Apicallymph nodes dissection is performed.
Primary Outcome Measure Information:
Title
Anastomotic leakage
Description
Anastomosis leakage rate after surgery, acute or chronic
Time Frame
3 months
Secondary Outcome Measure Information:
Title
proximal bowel necrosis
Description
Proximal bowel necrosis rate after surgery, acute or chronic
Time Frame
3 months
Title
proximal bowel stenosis
Description
Proximal bowel stenosis rate after surgery, acute or chronic
Time Frame
3 months
Title
Characteristics of the division branches of the inferior mesenteric artery in Chinese people
Description
e.g.,The distance from the left colon artery to the root of inferior mesenteric artery(cm).
Time Frame
1-2 days
Title
Apical Lymph Nodes Positive Rate
Description
Apical Lymph Nodes Positive Rate
Time Frame
14 days
Title
Conversion rate to laparotomy
Description
Conversion rate to laparotomy
Time Frame
5-years
Title
Complications of defunctioning stoma
Description
Complications of defunctioning stoma
Time Frame
3 months
Title
Early postoperative complications: Anastomotic bleeding, etc.
Description
Early postoperative complications: Anastomotic bleeding, etc.
Time Frame
30 days
Title
Anastomosis stenosis rate after surgery
Description
Anastomosis stenosis rate after surgery
Time Frame
30 days
Title
Mortality rate in 3 months after surgery
Description
Mortality rate in 3 months after surgery
Time Frame
3 months
Title
Life quality
Description
Life quality is measured by questionnaire(EORTC QLQ-C30 (version 3)).
Time Frame
5-years
Title
Micturition function scoring
Description
Micturition function is measured by questionnaire(IPSS).
Time Frame
3 months
Title
Sexual function scoring
Description
Sexual function is measured by questionnaire(The IIEF-5 questionnaire).
Time Frame
3 months
Title
5-years overall survival rate
Description
5-years overall survival rate
Time Frame
5-years
Title
5-years disease free survival rate
Description
5-years disease free survival rate
Time Frame
5-years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ting Zou, MD
Phone
0086-15874865802
Email
zouting218@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei dong Liu, MD
Organizational Affiliation
Xiangya Hospital of Central South University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xi Xie, MD
Organizational Affiliation
Xiangya Hospital of Central South University
Official's Role
Study Director
Facility Information:
Facility Name
Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liu wei dong, doctor
Phone
0086-13873124855
Email
davidcsu@foxmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
we would like to share our data.
IPD Sharing Time Frame
Around 2025
IPD Sharing Access Criteria
Someone who has the same or similar research could contact us at davidcsu@foxmail.com
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Comparison of Low and High Ligation With Apical Lymph Node Dissection in the Laparoscopy Rectal Cancer

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