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Evaluation of local slow-release epidermal growth factor to promote the neoadjuvant chemotherapy after laparoscopic TME low colorectal anastomosis after healing the clinical efficacy and safety of study -- a multicenter, randomized, open, parallel controlled clinical trial

Evaluation of local slow-release epidermal growth factor to promote the neoadjuvant chemotherapy after laparoscopic TME low colorectal anastomosis after healing the clinical efficacy and safety of study -- a multicenter, randomized, open, parallel controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-17014194
Enrollment
Unknown
Registered
2017-12-28
Start date
2018-01-01
Completion date
Unknown
Last updated
2018-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

anastomotic fistula

Interventions

treatment group:drug administration (rhEGF)

Sponsors

Zhujiang hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Untreated patients without previous rectal surgery history; 2. Aged 18 to 60 years old; 3. Men or non pregnant,lactating women; 4. Pathological diagnosis is adenocarcinoma,diameter of tumor=3cm, distance from dentate line 3 to 5cm; 5. The new adjuvant chemotherapy has been successfully completed for 8 weeks.(2017 colorectal cancer NCCN guide); 6. Well nourished, ALB= 35 g/L, HGB=100 g/L; 7. The organ functions well, Biochemical tests meet the following conditions:ALT= 2.5×ULN,AST= 2.5×ULN,T-BiL= 1.5×ULN,Scr= 1.5×ULN; 8. Have signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Complete intestinal obstruction; 2. The frozen pelvic cavity was found before operation; 3. Long-term use of immunosuppressant or steroid drugs; 4. They also have severe or uncontrolled internal medical diseases and infections(AF,angina,cardiac insufficiency, The ejection fraction is less than 50%, Refractory hypertension, COPD, ect.); 5. Obese or overly alcoholic; 6. Severe or uncontrollable mental illness; 7. drug abuse,as well as medical, psychological or social conditions may interfere with patients' participation in the study or have an impact on the assessment of the results; 8. There is a history of severe ulcerative colitis or congenital macrocolic; 9. Allergic to natural and recombinant hEGF, glycerol, mannitol; 10. Tumor is widely metastasized and life is expected to be less than 6 months; 11. To participate in other clinical trials within three months.

Design outcomes

Primary

MeasureTime frame
white blood cell;C-reactive protein;anastomotic healing condition;anastomotic healing condition;

Countries

China

Contacts

Public ContactChunhui Cui

Zhujiang hospital of Southern Medical University

87075472@qq.com+86 13570541388

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026