Comparing minimally invasive and open surgery for pancreatic cancer
The Effect and Safety of Comparision Between Minimally-invasive and Open Pancreaticoduodenectomy for Pancreatic Cancer : A Randomized Prospective Trial
This study is testing whether a less invasive surgery for pancreatic cancer can be safer and more effective than the traditional open surgery for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT03747588 on ClinicalTrials.gov |
What this trial studies
This study compares the safety and efficiency of minimally invasive pancreaticoduodenectomy (including laparoscopic and robotic techniques) with traditional open pancreaticoduodenectomy for patients with pancreatic cancer. It is a prospective randomized trial where eligible patients are assigned to either surgical approach before their operation. Key outcomes evaluated include hospital stay, blood loss, surgical radicality, operation duration, complication rates, and long-term survival metrics such as disease-free and overall survival.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with resectable or borderline resectable pancreatic cancer or related cancers who are scheduled for pancreatoduodenectomy.
Not a fit: Patients with benign tumors of the pancreas or those with significant intraoperative complications that require conversion to open surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and recovery for patients undergoing surgery for pancreatic cancer.
How similar studies have performed: Other studies have shown promising results in comparing minimally invasive and open surgical techniques, indicating that this approach is both relevant and potentially beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: \>18yr, \<75yr * Patients with pancreatic cancer or non-pancreatic cancers (biliary duct cancer or ampullary cancer) who underwent pancreatoduodenectomy * Preoperative imaging assessment is resectable or borderline resectable Exclusion Criteria: * Benign tumors of the head of pancreas * Enhanced CT diagnosis revealed that the excess of SMV was more than 180 degrees, or distant metastasis. * conversion to laparotomy because of intraoperative difficulty
Where this trial is running
Beijing, Beijing Municipality
- Chinese Academy of Medical Sciences & Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Menghua Dai, MD
- Email: DaiMH@pumch.cn
- Phone: +861069152600
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.