Rectal CancerNCT06146946
Safety of Mid and Low Rectal Cancer Surgery Without Dissection of the No.253 Lymph Node (S-M-O-O-T-H)
A study testing Dissection of the No.253 lymph node and Omitting the dissection of the No.253 lymph node in people with Rectal Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 8 sites in China.
Trial summary
The goal of this clinical trial is to learn about whether it is safe to omit dissection of the No.253 lymph nodes in mid and low rectal cancer surgery. The main question it aims to answer is that if it is possible to achieve the same long-term survival with and without the dissection of the No.253 lymph node in mid… 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?
- Dissection of the No.253 lymph node and Omitting the dissection of the No.253 lymph node
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,384 participants
- Where
- 8 sitesChina
- Study dates
- 1 Dec 2023to 1 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patient age between 18-75 years.
- Colonic biopsy pathology confirms adenocarcinoma.
- The inferior margin of the primary tumor is ≤ 7 cm from the anal verge, as confirmed by colonoscopy and baseline imaging at initial diagnosis.
- At initial treatment, imaging diagnoses the tumor T stage as less than or equal to 3.
- At initial treatment, imaging diagnoses no enlarged lymph nodes at the root of the inferior mesenteric artery.
- At initial treatment, imaging diagnoses the number of mesenteric metastatic lymph nodes as less than or equal to three.
- Strong willingness for surgery and signed informed consent.
Who cannot join
- Previous history of malignant colorectal tumors.
- Colonic biopsy pathology reveals mucinous adenocarcinoma or signet ring cell carcinoma.
- Imaging diagnosis of distant metastasis.
- Patients who have undergone multiple abdominal-pelvic surgeries or have extensive abdominal adhesions.
- Patients with complications such as intestinal obstruction, intestinal perforation, or intestinal bleeding requiring emergency surgery.
- Extensive lesions not amenable to R0 resection.
Show all 11Show fewer
- Diagnosed with other malignancies within the past five years.
- ASA (American Society of Anesthesiologists) classification ≥ IV and/or ECOG (Eastern Cooperative Oncology Group) performance status score ≥ 2.
- Patients with severe liver, kidney, cardiac, pulmonary, coagulation dysfunctions, or serious underlying diseases that cannot tolerate surgery.
- History of severe mental illness.
- Pregnant or breastfeeding women.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
China8 sites, 8 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100021
Yi Xiao, Dr., 13366036387
Yi Xiao, Dr.
- Not yet recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Lei Zhou, Dr., 13910279583
Lei Zhou, Dr.
- Not yet recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Aiwen Wu, Dr., 13911577190
Aiwen Wu, Dr.
- Not yet recruiting
Chinese PLA General Hospital
Beijing, Beijng, 100141
Xiaohui Du, Dr.
Xiaohui Du, Dr.
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Chaoyang District, 100021
Qian Liu, M.D., 13601008906, fcwpumch@163.com
Mingguang Zhang, M.D., +8613261967603, zmgslimshady@163.com
- Not yet recruiting
West China Hospital Sichuan University
Chengdu, Sichuan, 610044
Ziqiang Wang, Dr.
Ziqiang Wang
- Not yet recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Minhua Zheng
Minhua Zheng
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xinxiang Li, Dr.
Xinxiang Li
About this study
Official title: Safety of Mid and Low Rectal Cancer Surgery Without Dissection of the No.253 Lymph Node, a Prospective, Multicenter, Non-inferior Randomized Controlled Trial
The goal of this clinical trial is to learn about whether it is safe to omit dissection of the No.253 lymph nodes in mid and low rectal cancer surgery. The main question it aims to answer is that if it is possible to achieve the same long-term survival with and without the dissection of the No.253 lymph node in mid and low rectal cancer surgery. Participants will underwent laparoscopic rectal radical resection with or without the dissection of the No.253 lymph node.
Read the detailed description
The No.253 lymph node, as the third station in the inferior mesenteric artery lymphatic system, plays a significant role in the lymphatic circulation of the descending colon, sigmoid colon, and rectum. They act as the last barrier for tumor metastasis from the regional to distant areas. However, there is still controversy regarding whether rectal cancer patients universally require dissection of the No.253 lymph node. The rate of metastasis to the No.253 lymph node in rectal cancer patients is extremely low, and dissection may not bring survival benefits. Additionally, postoperative urinary and sexual functions may be impaired due to damage to the sympathetic nerves. However, current prospective randomized controlled trials on the safety of omitting the dissection of the No.253 lymph node have small sample sizes and lack sufficient test power. Further confirmation is needed from large-sample prospective randomized controlled studies. Based on this, the investigator plans to collaborate with Peking Union Medical College Hospital, China-Japan Friendship Hospital, Chinese People's Liberation Army General Hospital, Shanghai Ruijin Hospital, Fudan Cancer Hospital, and West China Hospital of Sichuan University, totaling eight medical centers, to conduct a prospective randomized controlled study. This study aims to confirm the safety of mid and low rectal surgery without dissection of the No.253 lymph node, providing high-level evidence-based medical evidence for the implementation of this surgical technique.
- Conditions
- Rectal Cancer
- Being tested
- Dissection of the No.253 lymph node, Omitting the dissection of the No.253 lymph node
- Keywords
- Rectal cancer, Lymph node dissection, No.253 lymph node
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dissection of the No.253 lymph nodeProcedure or surgery
The range of the No.253 lymph node is as follows: medially, it extends from the root of the inferior mesenteric artery to the starting section of the left colonic artery; caudally, from the starting point of the left colonic artery to the intersection with the inferior mesenteric vein; laterally, it is bordered by the outer margin of the inferior mesenteric vein; and cranially, from the horizontal section of the duodenum to the beginning of the jejunum. In the controlled group, the surgery is performed with dissection of the No.253 lymph node.
Omitting the dissection of the No.253 lymph nodeProcedure or surgery
In the experimental group, the surgery is performed without dissection of the No.253 lymph node.
| Study group | Role | What they receive |
|---|---|---|
| Omitting dissection of the No.253 lymph node | Experimental | Perform surgery based on the principle of Total Mesorectal Excision (TME), without denuding the root of the Inferior Mesenteric Artery (IMA) and without dissection of the No.253 lymph node. Ligation of the IMA is performed at a low position distal to the origin of the left colonic artery. Receives: Procedure: Omitting the dissection of the No.253 lymph node |
| Dissection of the No.253 lymph node | Active comparator | Perform surgery based on the principle of Total Mesorectal Excision (TME). During the procedure, fully expose the root of the Inferior Mesenteric Artery (IMA), thoroughly dissect the No.253 lymph node, and perform a high ligation along the artery at the root of the IMA; or expose the bifurcation of the left colonic artery, ligating the IMA at a low position distal to the origin of the left colonic artery, ensuring the dissection of the No. 253 lymph node while preserving the left colonic artery. Receives: Procedure: Dissection of the No.253 lymph node |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease free survival rate
Disease free survival refers to the length of time after primary treatment during which a patient survives without any signs or symptoms of the cancer.
Measured: 3 years after surgery
Secondary outcomes (8)
Number of harvested lymph nodes
Total number of lymph nodes dissected in the pathology report
Measured: About 10 days after surgery
Incidence of postoperative complications
The proportion of short-term complications occurring within 30 days post-surgery
Measured: 30 days after surgery
Intraoperative blood loss
Total blood loss during the surgery
Measured: Intraoperative
Operative duration
total time spent performing a surgical procedure. This time is typically measured from the moment the surgery begins (marked by the initial incision) to its conclusion (marked by the closure of the surgical wound)
Measured: Intraoperative
Postoperative urination and sexual function
Three months, six months, and one year postoperatively, evaluate patients' urinary and sexual functions using scales.
Measured: 1 year after surgery
3-year local recurrence rate
Local recurrence refers to the return of cancer in the same area where it originally developed, typically after treatment has been completed.
Measured: 3 years after surgery
3-year overall survival rate
Overall survival refers to the length of time from the primary treatment that patients are still alive.
Measured: 3 years after surgery
Rate of conversion to open surgery
The proportion of patients assigned to laparoscopic colorectal resection who require unplanned conversion to open laparotomy during the index surgery. Conversion is defined as abandonment of the planned laparoscopic approach and performance of open laparotomy due to intraoperative circumstances including uncontrollable hemorrhage, severe pelvic/abdominal adhesions, iatrogenic organ or vascular injury, inadequate surgical visualization, or inability to achieve oncologically complete resection via the laparoscopic route. The conversion rate is calculated as the number of converted cases divided by the total number of patients in the assigned laparoscopic group.
Measured: From initial skin incision to skin closure at the conclusion of the index operation (full intraoperative period).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start1 Dec 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- 1,384 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital, China-Japan Friendship Hospital, Fudan University, Peking University Cancer Hospital & Institute, Shanghai 10th People's Hospital, Affiliated Hospital of Qinghai University, First Hospital of China Medical University, The First Affiliated Hospital of Shanxi Medical University, Qianfoshan Hospital, Subei People's Hospital of Jiangsu Province, Yuncheng Central Hospital, Shanxi Province Cancer Hospital, Liaoning Cancer Hospital & Institute, The First Hospital of Jilin University, Beijing Friendship Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, Shandong Provincial Hospital, Yunnan Cancer Hospital, The Fourth Affiliated Hospital of Harbin Medical University, Tianjin Medical University Cancer Institute and Hospital, Sixth Affiliated Hospital, Sun Yat-sen University, Beijing Chao Yang Hospital, Guangdong Second Provincial General Hospital, First Affiliated Hospital of Chongqing Medical University, Army Medical Center of PLA, Zhejiang Cancer Hospital, First Affiliated Hospital of Wenzhou Medical University, Huizhou Municipal Central Hospital, Sixth Hospital of Shanxi Medical University, Shengjing Hospital, Tang-Du Hospital, Henan Cancer Hospital, Ruijin Hospital, The Affiliated Hospital of Qingdao University, First Affiliated Hospital, Sun Yat-Sen University, Tianjin Union Medical Center
- Responsible party
- Principal investigator, QIAN LIU, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Qian Liu, Principal investigator, Cancer Hospital Chinese Academy of Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146946
- Sponsor's protocol ID
- NCC4278
- Status last verified
- Sep 2026
- First submitted
- 18 Nov 2023
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang M, Dong S, Zhou H, Pei W, Zheng Z, Feng Q, Tang J, Jiang Z, Liang J, Liu Q. Safety of laparoscopic surgery without No.253 lymph node dissection for mid and low rectal cancer (SMOOTH): study protocol for a phase III, multicentre randomised controlled trial in China. BMJ Open. 2026 Sep 25;16(9):e115749. doi: 10.1136/bmjopen-2025-115749.
PubMed 42790919
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Mid and Low Rectal Cancer Surgery Without Dissection of the No.253 Lymph Node, a Prospective, Multicenter, Non-inferior Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06146946
- Acronym / sponsor ID
- NCC4278
- Conditions
- Rectal Cancer
- Keywords
- Rectal cancer, Lymph node dissection, No.253 lymph node
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,384 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, China-Japan Friendship Hospital, Fudan University, Peking University Cancer Hospital & Institute, Shanghai 10th People's Hospital, Affiliated Hospital of Qinghai University, First Hospital of China Medical University, The First Affiliated Hospital of Shanxi Medical University, Qianfoshan Hospital, Subei People's Hospital of Jiangsu Province, Yuncheng Central Hospital, Shanxi Province Cancer Hospital, Liaoning Cancer Hospital & Institute, The First Hospital of Jilin University, Beijing Friendship Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, Shandong Provincial Hospital, Yunnan Cancer Hospital, The Fourth Affiliated Hospital of Harbin Medical University, Tianjin Medical University Cancer Institute and Hospital, Sixth Affiliated Hospital, Sun Yat-sen University, Beijing Chao Yang Hospital, Guangdong Second Provincial General Hospital, First Affiliated Hospital of Chongqing Medical University, Army Medical Center of PLA, Zhejiang Cancer Hospital, First Affiliated Hospital of Wenzhou Medical University, Huizhou Municipal Central Hospital, Sixth Hospital of Shanxi Medical University, Shengjing Hospital, Tang-Du Hospital, Henan Cancer Hospital, Ruijin Hospital, The Affiliated Hospital of Qingdao University, First Affiliated Hospital, Sun Yat-Sen University, Tianjin Union Medical Center
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 27 Nov 2023 (actual)
- 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.
The goal of this clinical trial is to learn about whether it is safe to omit dissection of the No.253 lymph nodes in mid and low rectal cancer surgery. The main question it aims to answer is that if it is possible to achieve the same long-term survival with and without the dissection of the No.253 lymph node in mid and low rectal cancer surgery. Participants will underwent laparoscopic rectal radical resection with or without the dissection of the No.253 lymph node.
Detailed description
The No.253 lymph node, as the third station in the inferior mesenteric artery lymphatic system, plays a significant role in the lymphatic circulation of the descending colon, sigmoid colon, and rectum. They act as the last barrier for tumor metastasis from the regional to distant areas. However, there is still controversy regarding whether rectal cancer patients universally require dissection of the No.253 lymph node. The rate of metastasis to the No.253 lymph node in rectal cancer patients is extremely low, and dissection may not bring survival benefits. Additionally, postoperative urinary and sexual functions may be impaired due to damage to the sympathetic nerves. However, current prospective randomized controlled trials on the safety of omitting the dissection of the No.253 lymph node have small sample sizes and lack sufficient test power. Further confirmation is needed from large-sample prospective randomized controlled studies. Based on this, the investigator plans to collaborate with Peking Union Medical College Hospital, China-Japan Friendship Hospital, Chinese People's Liberation Army General Hospital, Shanghai Ruijin Hospital, Fudan Cancer Hospital, and West China Hospital of Sichuan University, totaling eight medical centers, to conduct a prospective randomized controlled study. This study aims to confirm the safety of mid and low rectal surgery without dissection of the No.253 lymph node, providing high-level evidence-based medical evidence for the implementation of this surgical technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omitting dissection of the No.253 lymph node | Experimental | Procedure: Omitting the dissection of the No.253 lymph nodePerform surgery based on the principle of Total Mesorectal Excision (TME), without denuding the root of the Inferior Mesenteric Artery (IMA) and without dissection of the No.253 lymph node. Ligation of the IMA is performed at a low position distal to the origin of the left colonic artery. |
| Dissection of the No.253 lymph node | Active comparator | Procedure: Dissection of the No.253 lymph nodePerform surgery based on the principle of Total Mesorectal Excision (TME). During the procedure, fully expose the root of the Inferior Mesenteric Artery (IMA), thoroughly dissect the No.253 lymph node, and perform a high ligation along the artery at the root of the IMA; or expose the bifurcation of the left colonic artery, ligating the IMA at a low position distal to the origin of the left colonic artery, ensuring the dissection of the No. 253 lymph node while preserving the left colonic artery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient age between 18-75 years.
- Colonic biopsy pathology confirms adenocarcinoma.
- The inferior margin of the primary tumor is ≤ 7 cm from the anal verge, as confirmed by colonoscopy and baseline imaging at initial diagnosis.
- At initial treatment, imaging diagnoses the tumor T stage as less than or equal to 3.
- At initial treatment, imaging diagnoses no enlarged lymph nodes at the root of the inferior mesenteric artery.
Key exclusion criteria (11 listed)
- Previous history of malignant colorectal tumors.
- Colonic biopsy pathology reveals mucinous adenocarcinoma or signet ring cell carcinoma.
- Imaging diagnosis of distant metastasis.
- Patients who have undergone multiple abdominal-pelvic surgeries or have extensive abdominal adhesions.
- Patients with complications such as intestinal obstruction, intestinal perforation, or intestinal bleeding requiring emergency surgery.
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 |
|---|---|---|
| Dissection of the No.253 lymph nodeThe range of the No.253 lymph node is as follows: medially, it extends from the root of the inferior mesenteric artery to the starting section of the left colonic artery; caudally, from the starting point of the left colonic artery to the intersection with the inferior mesenteric vein; laterally, it is bordered by the outer margin of the inferior mesenteric vein; and cranially, from the horizontal section of the duodenum to the beginning of the jejunum. In the controlled group, the surgery is performed with dissection of the No.253 lymph node. | Procedure or surgery | Dissection of the No.253 lymph node |
| Omitting the dissection of the No.253 lymph nodeIn the experimental group, the surgery is performed without dissection of the No.253 lymph node. | Procedure or surgery | Omitting dissection of the No.253 lymph node |
Primary outcome
3-year disease free survival rate
Time frame: 3 years after surgery
Disease free survival refers to the length of time after primary treatment during which a patient survives without any signs or symptoms of the cancer.
8 secondary outcomes
Number of harvested lymph nodes
Time frame: About 10 days after surgery
Incidence of postoperative complications
Time frame: 30 days after surgery
Intraoperative blood loss
Time frame: Intraoperative
Operative duration
Time frame: Intraoperative
Postoperative urination and sexual function
Time frame: 1 year after surgery
3-year local recurrence rate
Time frame: 3 years after surgery
3-year overall survival rate
Time frame: 3 years after surgery
Rate of conversion to open surgery
Time frame: From initial skin incision to skin closure at the conclusion of the index operation (full intraoperative period).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Derived from this study: PubMed 42790919Zhang M, Dong S, Zhou H, Pei W, Zheng Z, Feng Q, Tang J, Jiang Z, Liang J, Liu Q. Safety of laparoscopic surgery without No.253 lymph node dissection for mid and low rectal cancer (SMOOTH): study protocol for a phase III, multicentre randomised controlled trial in China. BMJ Open. 2026 Sep 25;16(9):e115749. doi: 10.1136/bmjopen-2025-115749.
- Individual participant dataSharing planned: No
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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.
Qian Liu principal investigator
Cancer Hospital Chinese Academy of Medical Science
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dissection of the No.253 lymph node and Omitting the dissection of the No.253 lymph node in people with Rectal Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 8 sites 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 7 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mingguang Zhang, Dr. (+8613261967603, zmgslimshady@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year disease free survival rate (time frame: 3 years after surgery). 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 NCT06146946, which also lists 1 linked publication.
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 15 Sep 2026.