Rectal CancerNCT03013153
Low or High Ligation of the IMA With Apical Lymph Node Dissection in Rectal Cancer Laparoscopic Surgery
A study testing Low ligation with apical lymph node dissection and High ligation in people with Rectal Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Low ligation with apical lymph node dissection and High ligation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 748 participants
- Where
- 1 siteChina
- Study dates
- Dec 2016to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The sixth affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655
Meijin Huang, MD, +8613924073322, 13924073322@139.com
Jiaming Zhou, MD, +8613560031075, cysums03@163.com
About this study
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)
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.
Read the 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.
- Conditions
- Rectal Cancer
- Being tested
- Low ligation with apical lymph node dissection, High ligation
- Keywords
- Rectal Cancer, Inferior Mesenteric Artery, Ligation, Apical Lymph Nodes, Laparoscopy, IMA Types
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low ligation with apical lymph node dissectionProcedure or surgery
Also called LAND
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.
High ligationProcedure or surgery
Also called HL
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.
| Study group | Role | What they receive |
|---|---|---|
| Low ligation with apical lymph node dissection | Experimental | 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. Receives: Procedure: Low ligation with apical lymph node dissection |
| High ligation | Active comparator | 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. Receives: Procedure: High ligation |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-years overall survival rate
5-years overall survival rate
Measured: 5 years
Secondary outcomes (23)
5-years disease free survival rate
5-years disease free survival rate
Measured: 5 years
1-year overall survival rate
1-year overall survival rate
Measured: 1 year
1-year disease free survival rate
1-year disease free survival rate
Measured: 1 year
Anastomosis leakage rate
anastomosis leakage rate after surgery, acute or chronic
Measured: 6 months
Apical Lymph Nodes (LN) Positive Rate
Apical Lymph Nodes Positive Rate, No.253 LN
Measured: 1 week
Operation Time
Measured: 1 day
Blood loss during operation
Measured: 1 day
Complication incident rate of surgery
Measured: 1 day
conversion rate to laparotomy
Measured: 1 day
Identification of IMA perfusion type before surgery
Measured: 1 day
Identification of lymph node metastasis by CT
Measured: 7 days
Mortality rate in 30 days after surgery
Measured: 30 days
Recovery time after surgery
Measured: 60 days
White cell level
Measured: 7 days
C-reaction protein level
Measured: 7 days
Albumin level
Measured: 7 days
Anastomosis bleeding rate after surgery
Measured: 30 days
Anastomosis stenosis rate after surgery
Measured: 30 days
Intestinal dysfunction after stoma closure
Measured: 1 year
Anus function after surgery
Measured: 1 year
Life quality scoring
Measured: 1 year
Bladder residual urine volume
Measured: 1 year
Sexual function scoring
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 748 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meijin Huang, MD, Study director, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03013153
- Sponsor's protocol ID
- LAND
- Status last verified
- Dec 2016
- First submitted
- 31 Dec 2016
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Mari G, Maggioni D, Costanzi A, Miranda A, Rigamonti L, Crippa J, Magistro C, Di Lernia S, Forgione A, Carnevali P, Nichelatti M, Carzaniga P, Valenti F, Rovagnati M, Berselli M, Cocozza E, Livraghi L, Origi M, Scandroglio I, Roscio F, De Luca A, Ferrari G, Pugliese R. "High or low Inferior Mesenteric Artery ligation in Laparoscopic low Anterior Resection: study protocol for a randomized controlled trial" (HIGHLOW trial). Trials. 2015 Jan 27;16:21. doi: 10.1186/s13063-014-0537-5.
PubMed 25623323Bostrom P, Haapamaki MM, Matthiessen P, Ljung R, Rutegard J, Rutegard M. High arterial ligation and risk of anastomotic leakage in anterior resection for rectal cancer in patients with increased cardiovascular risk. Colorectal Dis. 2015 Nov;17(11):1018-27. doi: 10.1111/codi.12971.
PubMed 25851151Tanaka J, Nishikawa T, Tanaka T, Kiyomatsu T, Hata K, Kawai K, Kazama S, Nozawa H, Yamaguchi H, Ishihara S, Sunami E, Kitayama J, Watanabe T. Analysis of anastomotic leakage after rectal surgery: A case-control study. Ann Med Surg (Lond). 2015 May 11;4(2):183-6. doi: 10.1016/j.amsu.2015.05.002. eCollection 2015 Jun.
PubMed 26042185Dauser B, Herbst F. Diagnosis, management and outcome of early anastomotic leakage following colorectal anastomosis using a compression device: is it different? Colorectal Dis. 2014 Dec;16(12):O435-9. doi: 10.1111/codi.12742.
PubMed 25132419GRIFFITHS JD. Surgical anatomy of the blood supply of the distal colon. Ann R Coll Surg Engl. 1956 Oct;19(4):241-56. No abstract available.
PubMed 13363265Masoni L, Mari FS, Nigri G, Favi F, Gasparrini M, Dall'Oglio A, Pindozzi F, Pancaldi A, Brescia A. Preservation of the inferior mesenteric artery via laparoscopic sigmoid colectomy performed for diverticular disease: real benefit or technical challenge: a randomized controlled clinical trial. Surg Endosc. 2013 Jan;27(1):199-206. doi: 10.1007/s00464-012-2420-3. Epub 2012 Jun 26.
PubMed 22733197Hida J, Okuno K. High ligation of the inferior mesenteric artery in rectal cancer surgery. Surg Today. 2013 Jan;43(1):8-19. doi: 10.1007/s00595-012-0359-6. Epub 2012 Oct 7.
PubMed 23052748Murono K, Kawai K, Kazama S, Ishihara S, Yamaguchi H, Sunami E, Kitayama J, Watanabe T. Anatomy of the inferior mesenteric artery evaluated using 3-dimensional CT angiography. Dis Colon Rectum. 2015 Feb;58(2):214-9. doi: 10.1097/DCR.0000000000000285.
PubMed 25585080Seike K, Koda K, Saito N, Oda K, Kosugi C, Shimizu K, Miyazaki M. Laser Doppler assessment of the influence of division at the root of the inferior mesenteric artery on anastomotic blood flow in rectosigmoid cancer surgery. Int J Colorectal Dis. 2007 Jun;22(6):689-97. doi: 10.1007/s00384-006-0221-7. Epub 2006 Nov 3.
PubMed 17082922Battal B, Hamcan S, Akgun V, Bozkurt Y. Congenital superior-inferior mesenteric arterial variation or arc of Riolan due to occlusion of proximal superior mesenteric artery. Surg Radiol Anat. 2014 Apr;36(3):309-10. doi: 10.1007/s00276-013-1212-3. Epub 2013 Oct 18. No abstract available.
PubMed 24135762van Gulik TM, Schoots I. Anastomosis of Riolan revisited: the meandering mesenteric artery. Arch Surg. 2005 Dec;140(12):1225-9. doi: 10.1001/archsurg.140.12.1225.
PubMed 16365247Bertrand MM, Delmond L, Mazars R, Ripoche J, Macri F, Prudhomme M. Is low tie ligation truly reproducible in colorectal cancer surgery? Anatomical study of the inferior mesenteric artery division branches. Surg Radiol Anat. 2014 Dec;36(10):1057-62. doi: 10.1007/s00276-014-1281-y. Epub 2014 Mar 15.
PubMed 24633578Trencheva K, Morrissey KP, Wells M, Mancuso CA, Lee SW, Sonoda T, Michelassi F, Charlson ME, Milsom JW. Identifying important predictors for anastomotic leak after colon and rectal resection: prospective study on 616 patients. Ann Surg. 2013 Jan;257(1):108-13. doi: 10.1097/SLA.0b013e318262a6cd.
PubMed 22968068Hirst NA, Tiernan JP, Millner PA, Jayne DG. Systematic review of methods to predict and detect anastomotic leakage in colorectal surgery. Colorectal Dis. 2014 Feb;16(2):95-109. doi: 10.1111/codi.12411.
PubMed 23992097Silberhumer GR, Paty PB, Temple LK, Araujo RL, Denton B, Gonen M, Nash GM, Allen PJ, DeMatteo RP, Guillem J, Weiser MR, D'Angelica MI, Jarnagin WR, Wong DW, Fong Y. Simultaneous resection for rectal cancer with synchronous liver metastasis is a safe procedure. Am J Surg. 2015 Jun;209(6):935-42. doi: 10.1016/j.amjsurg.2014.09.024. Epub 2014 Dec 13.
PubMed 25601556
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03013153
- Acronym / sponsor ID
- LAND
- Conditions
- Rectal Cancer
- Keywords
- Rectal Cancer, Inferior Mesenteric Artery, Ligation, Apical Lymph Nodes, Laparoscopy, IMA Types
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 748 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 6 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low ligation with apical lymph node dissection | Experimental | Procedure: Low ligation with apical lymph node dissectionLeft 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. |
| High ligation | Active comparator | Procedure: High ligationOpen 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low ligation with apical lymph node dissectionAlso: LANDLow 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. | Procedure or surgery | Low ligation with apical lymph node dissection |
| High ligationAlso: HLHigh 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. | Procedure or surgery | High ligation |
Primary outcome
5-years overall survival rate
Time frame: 5 years
5-years overall survival rate
23 secondary outcomes
5-years disease free survival rate
Time frame: 5 years
1-year overall survival rate
Time frame: 1 year
1-year disease free survival rate
Time frame: 1 year
Anastomosis leakage rate
Time frame: 6 months
Apical Lymph Nodes (LN) Positive Rate
Time frame: 1 week
Operation Time
Time frame: 1 day
Blood loss during operation
Time frame: 1 day
Complication incident rate of surgery
Time frame: 1 day
conversion rate to laparotomy
Time frame: 1 day
Identification of IMA perfusion type before surgery
Time frame: 1 day
Identification of lymph node metastasis by CT
Time frame: 7 days
Mortality rate in 30 days after surgery
Time frame: 30 days
Recovery time after surgery
Time frame: 60 days
White cell level
Time frame: 7 days
C-reaction protein level
Time frame: 7 days
Albumin level
Time frame: 7 days
Anastomosis bleeding rate after surgery
Time frame: 30 days
Anastomosis stenosis rate after surgery
Time frame: 30 days
Intestinal dysfunction after stoma closure
Time frame: 1 year
Anus function after surgery
Time frame: 1 year
Life quality scoring
Time frame: 1 year
Bladder residual urine volume
Time frame: 1 year
Sexual function scoring
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
- Background: PubMed 25623323Mari G, Maggioni D, Costanzi A, Miranda A, Rigamonti L, Crippa J, Magistro C, Di Lernia S, Forgione A, Carnevali P, Nichelatti M, Carzaniga P, Valenti F, Rovagnati M, Berselli M, Cocozza E, Livraghi L, Origi M, Scandroglio I, Roscio F, De Luca A, Ferrari G, Pugliese R. "High or low Inferior Mesenteric Artery ligation in Laparoscopic low Anterior Resection: study protocol for a randomized controlled trial" (HIGHLOW trial). Trials. 2015 Jan 27;16:21. doi: 10.1186/s13063-014-0537-5.
- Background: PubMed 25851151Bostrom P, Haapamaki MM, Matthiessen P, Ljung R, Rutegard J, Rutegard M. High arterial ligation and risk of anastomotic leakage in anterior resection for rectal cancer in patients with increased cardiovascular risk. Colorectal Dis. 2015 Nov;17(11):1018-27. doi: 10.1111/codi.12971.
- Background: PubMed 26042185Tanaka J, Nishikawa T, Tanaka T, Kiyomatsu T, Hata K, Kawai K, Kazama S, Nozawa H, Yamaguchi H, Ishihara S, Sunami E, Kitayama J, Watanabe T. Analysis of anastomotic leakage after rectal surgery: A case-control study. Ann Med Surg (Lond). 2015 May 11;4(2):183-6. doi: 10.1016/j.amsu.2015.05.002. eCollection 2015 Jun.
- Background: PubMed 25132419Dauser B, Herbst F. Diagnosis, management and outcome of early anastomotic leakage following colorectal anastomosis using a compression device: is it different? Colorectal Dis. 2014 Dec;16(12):O435-9. doi: 10.1111/codi.12742.
- Background: PubMed 13363265GRIFFITHS JD. Surgical anatomy of the blood supply of the distal colon. Ann R Coll Surg Engl. 1956 Oct;19(4):241-56. No abstract available.
- Background: PubMed 22733197Masoni L, Mari FS, Nigri G, Favi F, Gasparrini M, Dall'Oglio A, Pindozzi F, Pancaldi A, Brescia A. Preservation of the inferior mesenteric artery via laparoscopic sigmoid colectomy performed for diverticular disease: real benefit or technical challenge: a randomized controlled clinical trial. Surg Endosc. 2013 Jan;27(1):199-206. doi: 10.1007/s00464-012-2420-3. Epub 2012 Jun 26.
- Background: PubMed 23052748Hida J, Okuno K. High ligation of the inferior mesenteric artery in rectal cancer surgery. Surg Today. 2013 Jan;43(1):8-19. doi: 10.1007/s00595-012-0359-6. Epub 2012 Oct 7.
- Background: PubMed 25585080Murono K, Kawai K, Kazama S, Ishihara S, Yamaguchi H, Sunami E, Kitayama J, Watanabe T. Anatomy of the inferior mesenteric artery evaluated using 3-dimensional CT angiography. Dis Colon Rectum. 2015 Feb;58(2):214-9. doi: 10.1097/DCR.0000000000000285.
- Background: PubMed 17082922Seike K, Koda K, Saito N, Oda K, Kosugi C, Shimizu K, Miyazaki M. Laser Doppler assessment of the influence of division at the root of the inferior mesenteric artery on anastomotic blood flow in rectosigmoid cancer surgery. Int J Colorectal Dis. 2007 Jun;22(6):689-97. doi: 10.1007/s00384-006-0221-7. Epub 2006 Nov 3.
- Background: PubMed 24135762Battal B, Hamcan S, Akgun V, Bozkurt Y. Congenital superior-inferior mesenteric arterial variation or arc of Riolan due to occlusion of proximal superior mesenteric artery. Surg Radiol Anat. 2014 Apr;36(3):309-10. doi: 10.1007/s00276-013-1212-3. Epub 2013 Oct 18. No abstract available.
- Background: PubMed 16365247van Gulik TM, Schoots I. Anastomosis of Riolan revisited: the meandering mesenteric artery. Arch Surg. 2005 Dec;140(12):1225-9. doi: 10.1001/archsurg.140.12.1225.
- Background: PubMed 24633578Bertrand MM, Delmond L, Mazars R, Ripoche J, Macri F, Prudhomme M. Is low tie ligation truly reproducible in colorectal cancer surgery? Anatomical study of the inferior mesenteric artery division branches. Surg Radiol Anat. 2014 Dec;36(10):1057-62. doi: 10.1007/s00276-014-1281-y. Epub 2014 Mar 15.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meijin Huang, MD study director
Sixth Affiliated Hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low ligation with apical lymph node dissection and High ligation in people with Rectal Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiaming Zhou, MD (+8613560031075, cysums03@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-years overall survival rate (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03013153, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.