Comparing laparoscopic and open surgery for pancreatic cancer
Multicenter Prospective Randomized Controlled Clinical Trial for Comparison Between Laparoscopic and Open Distal Pancreatectomy for Ductal Adenocarcinoma of the Pancreatic Body and Tail
NA · Seoul National University Hospital · NCT03957135
This study is testing whether laparoscopic surgery is as safe and effective as open surgery for patients with pancreatic cancer that can be removed.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 244 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | All |
| Sponsor | Seoul National University Hospital (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Seongnam-si, Kyeonggi-do) |
| Trial ID | NCT03957135 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of laparoscopic versus open distal pancreatectomy for patients with resectable pancreatic ductal adenocarcinoma located in the body and tail of the pancreas. It is a multicenter randomized controlled trial that aims to determine if laparoscopic surgery can achieve similar or better postoperative outcomes and survival rates compared to traditional open surgery. Patients will be randomly assigned to one of the two surgical approaches, and their postoperative outcomes and survival data will be analyzed to assess the feasibility of laparoscopic surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with resectable pancreatic ductal adenocarcinoma of the body and tail, without evidence of distant metastasis.
Not a fit: Patients with remote metastasis or those with a history of other malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide patients with a less invasive surgical option that may lead to improved recovery and survival rates.
How similar studies have performed: Other studies have shown promising results for laparoscopic approaches in similar surgical contexts, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance score 0-2 * Pancreatic ductal adenocarcinoma that is pathologically confirmed or shows characteristic radiologic features * Patients with resectable pancreatic cancer at the time of surgery (Including borderline resectable pancreatic cancer at the time of diagnosis or Locally advanced pancreatic cancer after chemotherapy or radiation therapy) * Lesion (within pancreatic body and tail) is located to the left of the left branch of the hepatic portal vein * No remote metastasis in preoperative imaging and not adjacent to the superior mesenteric vein, superior mesenteric artery, and abdominal artery * Patients without invasion of adjacent organs other than the left adrenal gland and mesocolon * Patients with informed consent Exclusion Criteria: * Patients with remote metastasis at the time of diagnosis of pancreatic cancer * History of other malignancy (Inclusive if there is no evidence of recurrence after 5 years of treatment) * In the case of invasion of other organs other than the left adrenal gland and mesocolon * Where major vascular resection, such as the portal vein or abdominal artery, is required to secure negative resection * Recurrent pancreatic cancer * Patients with underlying diseases at high risk of general anesthesia * Preperitoneal or other organ metastases found during surgery * In case of previously undergone pancreatic resection * Other subject whom the investigator deems inappropriate
Where this trial is running
Seongnam-si, Kyeonggi-do
- Seoul National University Bundang Hospital — Seongnam-si, Kyeonggi-do, Korea, Republic of (RECRUITING)
Study contacts
- Principal investigator: Ho-Seong Han, M.D. Ph.D. — Seoul National University Bundang Hospital
- Study coordinator: Jun Suh Lee, M.D. Ph.D.
- Email: rudestock@gmail.com
- Phone: +82-10-2747-6320
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.
Conditions: Pancreas Neoplasm Malignant Resectable, pancreas neoplasms, pancreatectomy