Comparing two surgical techniques for early-stage left-sided pancreatic cancer
Laparoscopic Radical Antegrade Modular Pancreatosplenectomy Versus Laparoscopic Distal Pancreatosplecnectomy in Selected Left-sided Pancreatic Cancer: a Multicenter Randomized Controlled Clinical Trial
This study is testing two different surgical methods to see which one works better for people with early-stage left-sided pancreatic cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05939063 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized controlled clinical trial aims to evaluate the outcomes of laparoscopic radical antegrade modular pancreatosplenectomy (LRAMPS) versus laparoscopic distal pancreatosplenectomy (LDP) in patients with early-stage left-sided pancreatic cancer. The study focuses on patients with tumors that meet specific criteria, including size and location, to ensure optimal surgical intervention. By comparing the perioperative and oncological outcomes of these two surgical approaches, the trial seeks to establish the most effective treatment for this condition. The research addresses a gap in existing literature regarding the use of LRAMPS for early-stage tumors.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with resectable left-sided pancreatic cancer, with tumors measuring 4 cm or less and meeting specific anatomical criteria.
Not a fit: Patients with advanced disease, such as those with distant metastasis or multifocal tumors, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective surgical option for patients with early-stage left-sided pancreatic cancer, potentially improving their survival rates and quality of life.
How similar studies have performed: While previous studies have explored LRAMPS in more advanced stages of pancreatic cancer, this trial is novel in its focus on early-stage tumors and the specific comparison of LRAMPS and LDP.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinically diagnosed as resectable left-sided pancreatic cancer before surgery. * Imaging tumor diameter ≤ 4 cm. * Located ≥ 1cm from the celiac trunk. * Tumor didn't invade the fascial layer behind the pancreas. * Be able to comply with research protocol. * Voluntary participation and signed informed consent. Exclusion Criteria: * Received neoadjuvant therapy. * Presence of liver or other distant metastasis. * Multifocal or recurrent disease. * History of other malignancies. * Simultaneously participating in other clinical trials.
Where this trial is running
Shanghai, Shanghai Municipality
- Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Xianjun Yu, MD, PhD — Fudan University
- Study coordinator: Xianjun Yu, MD, PhD
- Email: yuxianjun@fudanpci.org
- Phone: +86-13801669875
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.