Clinical trial · Interventional
Low or High Ligation of the IMA With Apical Lymph Node Dissection in Rectal Cancer Laparoscopic Surgery
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)
NCT03013153CI-TRIAL-00025468unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High ligation | Procedure | — | UNRESOLVED |
| Low ligation with apical lymph node dissection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Low ligation with apical lymph node dissection
- description
- 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.
- interventionNames
- Procedure: Low ligation with apical lymph node dissection
- type
- ACTIVE_COMPARATOR
- label
- High ligation
- description
- 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.
- interventionNames
- Procedure: High ligation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (23)
- BACKGROUNDMari 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. PMID 25623323
- BACKGROUNDBostrom 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. PMID 25851151
- BACKGROUNDTanaka 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. PMID 26042185
- BACKGROUNDDauser 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. PMID 25132419
- BACKGROUNDGRIFFITHS 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. PMID 13363265
- BACKGROUNDMasoni 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.