Status:
NOT_YET_RECRUITING
Prospective Phase II Study on Continuous Circumferential Reinforcement of Laparoscopic Rectal Anastomosis to Prevent Complications
Lead Sponsor:
ZHI-ZHONG PAN
Conditions:
Colorectal Cancer
Anastomotic Leakage
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Anastomotic leakage (AL) is one of the most severe complications following laparoscopic rectal cancer surgery. According to the International Study Group of Rectal Cancer (ISREC), AL is defined as a d...
Eligibility Criteria
Inclusion
- Histological Confirmation:
- Diagnosed with rectal adenocarcinoma confirmed by histology.
- Tumor Location:
- MRI confirms a mid to upper rectal tumor, with the lower margin of the tumor located 6-12 cm from the anal verge.
- Preoperative Staging:
- Preoperative MRI staging indicates the presence or absence of MRF positivity and/or EMVI positivity; the surgical team assesses the tumor as resectable with an estimated R0 resection.
- Bowel Obstruction:
- No signs of bowel obstruction.
- Neoadjuvant Chemoradiotherapy:
- For patients who have received neoadjuvant chemoradiotherapy, complete radiotherapy and baseline imaging records must be available at this center.
- Previous Treatments:
- Surgical History:
- No previous colorectal surgery.
- Biological and Immunotherapy:
- No prior treatment with biological drugs (e.g., monoclonal antibodies), immunotherapy (e.g., anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-PD-L2 antibodies, or anti-CTLA-4), or other investigational drugs.
- Endocrine Therapy:
- No restrictions on prior endocrine therapy.
- Patient Characteristics:
- Age:
- Between 18 and 75 years old.
- Performance Status:
- ECOG performance status of 0-1 (see Appendix 3).
- Life Expectancy:
- Greater than 2 years.
- Hematological Parameters:
- WBC \> 3×10\^9/L; PLT \> 80×10\^9/L; Hb \> 90 g/L.
- Liver Function:
- ALT and AST less than 2 times the upper limit of normal; bilirubin less than 1.5 times the upper limit of normal.
- Renal Function:
- Creatinine less than 1.5 times the upper limit of normal or creatinine clearance (CCr) ≥ 60 ml/min.
Exclusion
- Patients meeting any of the following conditions will be excluded from the study:
- Need for Multiorgan Resection:
- Patients requiring combined organ resection.
- Preventive or Permanent Stoma:
- Patients requiring preventive or permanent stoma.
- Hartmann or Miles Procedures:
- Patients requiring Hartmann's procedure or Miles' surgery.
- Cardiac Conditions:
- Arrhythmias requiring antiarrhythmic treatment (excluding β-blockers or digoxin), symptomatic coronary artery disease, localized myocardial ischemia (myocardial infarction within the last 6 months), or congestive heart failure beyond NYHA Class II.
- Uncontrolled Hypertension:
- Severe hypertension that is not well controlled by medication.
- Infectious Diseases:
- History of HIV infection or active chronic hepatitis B or C with high viral DNA copies.
- Active Tuberculosis (TB):
- Subjects with active pulmonary tuberculosis, currently undergoing anti-tuberculosis treatment, or having received anti-tuberculosis treatment within 1 year prior to screening.
- Severe Infections:
- Other active clinically severe infections (according to NCI-CTC version 5.0).
- Evidence of Distant Metastasis:
- Preoperative evidence of distant metastasis outside the pelvis.
- Cachexia and Organ Failure:
- Cachexia or decompensated organ function.
- Radiotherapy History:
- History of pelvic or abdominal radiotherapy.
- Multiple Primary Colorectal Cancers:
- Presence of multiple primary colorectal cancers.
- Seizure Disorders:
- Patients with seizures requiring treatment (e.g., steroids or antiepileptic therapy).
- History of Other Malignancies:
- History of other malignancies within the past 5 years, except for cured in situ cervical cancer or basal cell carcinoma of the skin.
- Substance Abuse:
- Substance abuse or medical, psychological, or social conditions that could interfere with the patient's participation in the study or the evaluation of study results.
- Allergies:
- Known or suspected allergies to the investigational drug or any drug related to the study.
- Unstable Conditions:
- Any unstable condition or situation that might jeopardize patient safety and compliance.
- Pregnancy or Lactation:
- Women who are pregnant or breastfeeding, and women of childbearing potential not using adequate contraceptive measures.
- Informed Consent:
- Refusal to sign the informed consent form.
Key Trial Info
Start Date :
July 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT06495853
Start Date
July 20 2024
End Date
November 1 2025
Last Update
July 11 2024
Active Locations (1)
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1
Colorectal Department,SunYat-sen University Cancer Center
Guangzhou, Guangdong, China, 510062