BridgeMD
Tests treatment safety and results for Rectal Cancer
Official title Safety of Mid and Low Rectal Cancer Surgery Without Dissection of the No.253 Lymph Node (S-M-O-O-T-H)
ClinicalTrials.gov ID: NCT06146946
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patient age between 18-75 years.
- Colonic biopsy pathology confirms adenocarcinoma.
- At initial treatment, colonoscopy and imaging diagnose the tumor's lower edge as less than or equal to 7cm from the anus.
- 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.
You likely can't join if
- 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.
See the full eligibility criteria
- Patient age between 18-75 years.
- Colonic biopsy pathology confirms adenocarcinoma.
- At initial treatment, colonoscopy and imaging diagnose the tumor's lower edge as less than or equal to 7cm from the anus.
- 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.
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Beijing, Beijng, China
- Beijing, Chaoyang District, China
- Shanghai, Shanghai Municipality, China
- Chengdu, Sichuan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Beijing, Beijng, China; Beijing, Chaoyang District, China; Shanghai, Shanghai Municipality, China; Chengdu, Sichuan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.