Safety of Mid and Low Rectal Cancer Surgery Without Dissection of the No.253 Lymph Node (S-M-O-O-T-H)

ConditionRectal Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dissection of the No.253 lymph node

    Procedure/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 node

    Procedure/Surgery

    In the experimental group, the surgery is performed without dissection of the No.253 lymph node.

Treatment groups

1,384 Participants
are divided into 2 treatment groups
Group A: Omitting dissection of the No.253 lymph nodeExperimental treatment 1 intervention
Group B: Dissection of the No.253 lymph nodeActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
3 years after surgery

Secondary outcomes

1

Number of harvested lymph nodes

Total number of lymph nodes dissected in the pathology report

Time frame
About 10 days after surgery
2

Incidence of postoperative complications

The proportion of short-term complications occurring within 30 days post-surgery

Time frame
30 days after surgery
3

Intraoperative blood loss

Total blood loss during the surgery

Time frame
Intraoperative
4

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)

Time frame
Intraoperative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor

Peking Union Medical College Hospital

Collaborator

China-Japan Friendship Hospital

Collaborator

Fudan University

Collaborator

Peking University Cancer Hospital & Institute

Collaborator

Shanghai 10th People's Hospital

Collaborator

Affiliated Hospital of Qinghai University

Collaborator

First Hospital of China Medical University

Collaborator

The First Affiliated Hospital of Shanxi Medical University

Collaborator

Qianfoshan Hospital

Collaborator

Subei People's Hospital of Jiangsu Province

Collaborator

Yuncheng Central Hospital

Collaborator

Shanxi Province Cancer Hospital

Collaborator

Liaoning Cancer Hospital & Institute

Collaborator

The First Hospital of Jilin University

Collaborator

Beijing Friendship Hospital

Collaborator

Second Affiliated Hospital, Zhejiang University, School of Medicine

Collaborator

Shandong Provincial Hospital

Collaborator

Yunnan Cancer Hospital

Collaborator

The Fourth Affiliated Hospital of Harbin Medical University

Collaborator

Tianjin Medical University Cancer Institute and Hospital

Collaborator

Sixth Affiliated Hospital, Sun Yat-sen University

Collaborator

Beijing Chao Yang Hospital

Collaborator

Guangdong Second Provincial General Hospital

Collaborator

First Affiliated Hospital of Chongqing Medical University

Collaborator

Army Medical Center of PLA

Collaborator

Zhejiang Cancer Hospital

Collaborator

First Affiliated Hospital of Wenzhou Medical University

Collaborator

Huizhou Municipal Central Hospital

Collaborator

Sixth Hospital of Shanxi Medical University

Collaborator

Shengjing Hospital

Collaborator

Tang-Du Hospital

Collaborator

Henan Cancer Hospital

Collaborator

Ruijin Hospital

Collaborator

The Affiliated Hospital of Qingdao University

Collaborator

First Affiliated Hospital, Sun Yat-Sen University

Collaborator

Tianjin Union Medical Center

Collaborator