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Low or High Ligation of the IMA With Apical Lymph Node Dissection in Rectal Cancer Laparoscopic Surgery

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ClinicalTrials.gov Identifier: NCT03013153
Recruitment Status : Unknown
Verified December 2016 by Sixth Affiliated Hospital, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : January 6, 2017
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):
Sixth Affiliated Hospital, Sun Yat-sen University

Study Description
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Brief Summary:
Laparoscopy colon surgery is accepted worldwide in the recent years. But there is still argument on the effect of laparoscopy rectal surgery. Laparoscopy has advantages on showing the inferior mesenteric artery (IMA), protection of autonomic nerve, low rectal anastomosis, and total mesorectum excision. However, debate on the level of IMA ligation and debonding of splenic flexure never ends. This study is going to give a clear and definite answer to how and why surgeons should deal with the IMA in laparoscopy rectal surgery，base on the 3D reconstruction of IMA and identification of IMA perfusion types.

Condition or disease Intervention/treatment Phase
Rectal Cancer Procedure: Low ligation with apical lymph node dissection Procedure: High ligation Not Applicable

Detailed Description:

According to the report of World Health Organization 2015, the morbility and mortality of colorectal cancer (CRC) are rising all over the world. Although the technique gets great approval in CRC surgical treatment in the recent years, such as TME protocol, neoadjuvant and laparoscopy technique, the complication of anastomosis leakage and nerve damage are still to be solved.

Laparoscopy colon surgery is accepted worldwide in the recent years. But there is still argument on the effect of laparoscopy rectal surgery. Laparoscopy has advantages on showing the inferior mesenteric artery, protection of autonomic nerve, low rectal anastomosis, and total mesorectum excision. However, debate on where is the best level of IMA ligation and whether splenic flexure be debonded never ends. This study is going to give a clear and definite answer to how and why surgeons should deal with the IMA in laparoscopy rectal surgery.

The ligation level of IMA affects on hypogastric and pelvic nerve, leads to disorder of sexual and urination functions. What's more, it also have affection on the apical lymph node (No.253) harvesting and the blood supplement of proximal colon. Former studies have proved that the blood supplement and tension of anastomosis leads to leakage after surgery. Meanwhile, the ligation level of IMA is the key point on it.

The former study comes from the sixth affiliated hospital found that the mistake of ligation level of IMA happened because of the poor touching and explosion with laparoscopy. The distance from the root of IMA to left colic artery (DRL) vary between 19mm and 64mm. When surgeon made mistake during ligation, it led to the insufficient resection of apical lymph node. Further more, affect the long-term survival. Besides, there are 4 different types of IMA according to the relationship between the left colic artery, sigmoid artery and superior rectal artery. These branches will confuse surgeon on how to deal with them. 3D reconstruction of abdominal pelvic CT is able to show the length of DRL, IMA types and apical lymph nodes clearly. With these technique, the investigators can preserve the left colic artery and resect apical lymph nodes precisely.

In the past studies, high or low ligation takes advantage on both side. But none of them comes from retrospective clinical trail. Some author believe that high ligation do better in resection of apical lymph nodes, release the tension of anastomosis, providing precise tumor staging. On the other side, some authors consider that high ligation may cut down blood supplement, rise the incident of anastomosis leakage (AL). so they prefer low ligation to the high. Some studies show that there are no long term survival difference between high and low ligation on IMA in laparoscopy rectal resection. So whether high ligation is necessary, still to be proved.

For local advanced rectal cancer, neoadjuvant chemotherapy can lesson tumor size, reduce recurrence, preserve annual better and rise long-term survival. National Comprehensive Cancer Network command chemotherapy before surgery (Total Mesorectal Excision TME) as the standard for rectal cancer since 2005. Another randomized controlled trial (RCT) named Neoadjuvant FOLFOX6 Chemotherapy With or Without Radiation in Rectal Cancer (FOWARC) NCT01211210 has proved the recent positive result. In those cases, the positive metastasis apical lymph node appeared in less than 5% (5/116) cases. On the other side, the incident of AL was up to 7% (8/116) . This phenomenon discover that maybe low ligation with apical lymph nodes dissection can get the same treatment effect and decrease AL from happening.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 748 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Low or High Ligation of the Inferior Mesenteric Artery With Apical Lymph Node Dissection in Rectal Cancer Laparoscopic Surgery: A Prospective, Multi-Center, Randomized, Open-Label, Parallel Group, Non-Inferiority Clinical Trial (LAND)
Study Start Date : December 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: Low ligation with apical lymph node dissection
Left colic artery (LCA) is identified according to the CT 3D-reconstruction, tie the sigmoid artery and superior rectal artery, preserved LCA while low ligation of the inferior mesenteric artery is performed. Lymphadenectomy to the apical lymph nodes (No.253)is performed around the IMA until 2 cm from the aorta. The inferior mesenteric vein (IMV) is divided and ligated below the pancreatic margin.
 Procedure: Low ligation with apical lymph node dissection
Low ligation with apical lymph node dissection (LAND). Left colic artery (LCA) is identified according to the CT 3D-reconstruction, tie the sigmoid artery and superior rectal artery, preserved LCA while low ligation of the inferior mesenteric artery is performed. Lymphadenectomy to the apical lymph nodes (No.253)is performed around the IMA until 2 cm from the aorta.
Other Name: LAND
Active Comparator: High ligation
Open the peritoneum proceeds cephalad towards the duodenojejunal angle of Treitz, and the mesenteric root is incised 1 cm below the inferior margin of the pancreas. The aortomesenteric window is opened wide and the inferior mesenteric vessels are exposed. The IMA is ligated and divided at 2 cm from its origin. The inferior mesenteric vein (IMV) is divided and ligated below the pancreatic margin.
 Procedure: High ligation
High ligation (HL) Open the peritoneum proceeds cephalad towards the duodenojejunal angle of Treitz, and the mesenteric root is incised 1 cm below the inferior margin of the pancreas. The aortomesenteric window is opened wide and the inferior mesenteric vessels are exposed. The IMA is ligated and divided at 2 cm from its origin. The inferior mesenteric vein (IMV) is divided and ligated below the pancreatic margin.
Other Name: HL


Outcome Measures
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Primary Outcome Measures :
  1. 5-years overall survival rate [ Time Frame: 5 years ]
    5-years overall survival rate


Secondary Outcome Measures :
  1. 5-years disease free survival rate [ Time Frame: 5 years ]
    5-years disease free survival rate

  2. 1-year overall survival rate [ Time Frame: 1 year ]
    1-year overall survival rate

  3. 1-year disease free survival rate [ Time Frame: 1 year ]
    1-year disease free survival rate

  4. Anastomosis leakage rate [ Time Frame: 6 months ]
    anastomosis leakage rate after surgery, acute or chronic

  5. Apical Lymph Nodes (LN) Positive Rate [ Time Frame: 1 week ]
    Apical Lymph Nodes Positive Rate, No.253 LN

  6. Operation Time [ Time Frame: 1 day ]
  7. Blood loss during operation [ Time Frame: 1 day ]
  8. Complication incident rate of surgery [ Time Frame: 1 day ]
  9. conversion rate to laparotomy [ Time Frame: 1 day ]
  10. Identification of IMA perfusion type before surgery [ Time Frame: 1 day ]
  11. Identification of lymph node metastasis by CT [ Time Frame: 7 days ]
  12. Mortality rate in 30 days after surgery [ Time Frame: 30 days ]
  13. Recovery time after surgery [ Time Frame: 60 days ]
  14. White cell level [ Time Frame: 7 days ]
  15. C-reaction protein level [ Time Frame: 7 days ]
  16. Albumin level [ Time Frame: 7 days ]
  17. Anastomosis bleeding rate after surgery [ Time Frame: 30 days ]
  18. Anastomosis stenosis rate after surgery [ Time Frame: 30 days ]
  19. Intestinal dysfunction after stoma closure [ Time Frame: 1 year ]
  20. Anus function after surgery [ Time Frame: 1 year ]
  21. Life quality scoring [ Time Frame: 1 year ]
  22. Bladder residual urine volume [ Time Frame: 1 year ]
  23. Sexual function scoring [ Time Frame: 1 year ]

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:

  • Pathology shows rectal or sigmoid adenocarcinoma
  • The bottom edge of tumor to anuas is less than 15cm
  • The clinical staging of tumor by American Joint Committee on Cancer (AJCC) within T2-4 or N1-2
  • Receive or not receive neoadjuvant chemotherapy based on 5-fluorouracil before surgery
  • Racial resection in available after neoadjuvant chemotherapy
  • No metastasis evidence was found
  • Annual preservation surgery is available
  • Tolerate to general anesthesia
  • Eastern Cooperative Oncology Group (ECOG) status score between 0 and 1
  • Patients and general anesthesia can understand the clinical trail well and are willing to take part in

Exclusion Criteria:

  • Suffer with other carcinoma synchronous or metachronous in 5 years
  • Multiple primary colon carcinoma
  • Radiation therapy was performed before surgery
  • History of colorectal surgery
  • Combine with acute intestinal obstruction, intestinal bleeding, intestinal perforation and emergency surgery is needed
  • Multiple organs resection surgery is needed
  • Abdominal perineal resection is performed
  • American Society of Anesthesiologists score stage IV to V
  • Pregnant, suckling period or reject to contraception
  • Severe cardiovascular disease, uncontrollable infection or other severe complication
  • Severe mental illness
  • Unable to go through the treatment because of family, society or regional condition
  • Refuse to take part in the trail
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): NCT03013153


Contacts
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Contact: Jiaming Zhou, MD +8613560031075 cysums03@163.com
Contact: Meijin Huang, MD +8613924073322 13924073322@139.com

Locations
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China, Guangdong
The sixth affiliated hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510655
Contact: Meijin Huang, MD    +8613924073322    13924073322@139.com   
Contact: Jiaming Zhou, MD    +8613560031075    cysums03@163.com   
Principal Investigator: Jiaping Wang, MD         
Principal Investigator: Meijin Huang, MD         
Sub-Investigator: Jiaming Zhou, MD         
Sponsors and Collaborators
Sixth Affiliated Hospital, Sun Yat-sen University
Investigators
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Study Director: Meijin Huang, MD The Sixth Affiliated Hospital, Sun Yat-sen University
More Information
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Publications:

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Responsible Party: Sixth Affiliated Hospital, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03013153    
Other Study ID Numbers: LAND
First Posted: January 6, 2017    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Sixth Affiliated Hospital, Sun Yat-sen University:
Rectal Cancer
Inferior Mesenteric Artery
Ligation
 Apical Lymph Nodes
Laparoscopy
IMA Types
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