Comparing Laparoscopic and Open Surgery for Pancreatic Carcinoma

Launched by TONGJI HOSPITAL · Dec 20, 2018

Keywords

ClinConnect Summary

This clinical trial is studying two different surgical approaches for treating pancreatic cancer: total laparoscopic pancreaticoduodenectomy (TLPD) and open pancreaticoduodenectomy (OPD). Both methods aim to remove the tumor and surrounding tissue, but they differ in how the surgery is performed. The trial will include 200 patients aged 18 to 75 who have been diagnosed with pancreatic cancer and are suitable for either type of surgery. Participants will be randomly assigned to one of the two groups, and the study aims to find out which method leads to better overall survival rates, disease-free survival, and quality of life after surgery.

To be eligible, patients must have a confirmed diagnosis of pancreatic cancer and be able to safely undergo either surgical procedure. They should also be willing to sign a consent form to participate. Throughout the trial, which will take about seven years, participants can expect to receive care that follows enhanced recovery after surgery (ERAS) guidelines, which aim to help them recover more quickly. This trial is particularly significant because it is one of the first large studies comparing these two surgical techniques at multiple centers, which could help improve treatment options for pancreatic cancer patients in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age between 18 years and 75 years.
• • 2. Histologically confirmed PDAC or clinically diagnosed PDAC by an MDT without histopathologic evidence.
• • 3. Patients feasible to undergo both LPD and OPD according to MDT evaluations.
• • 4. Patients understanding and willing to comply with this trial.
• • 5. Provision of written informed consent before patient registration.
• • 6. Patients meeting the curative treatment intent in accordance with clinical guidelines.
• Exclusion Criteria:
• • 1. Patients with distant metastases, including peritoneal, liver, distant lymph node metastases, and involvement of other organs.
• • 2. Patients requiring left, central or total pancreatectomy or other palliative surgery.
• • 3. Preoperative American Society of Anaesthesiologists (ASA) score ≥ 4.
• • 4. History of other malignant disease.
• • 5. Pregnant or breast-feeding women.
• • 6. Patients with serious mental disorders.
• • 7. Patients treated with neoadjuvant therapy.
• • 8. Patients with vascular invasion and requiring vascular resection as evaluated by the MDT team according to abdominal imaging data.
• • 9. Body mass index \> 35 kg/m2.
• • 10. Patients participating in any other clinical trials within 3 months.