Comparing two surgical methods for pancreatic cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness of total laparoscopic pancreaticoduodenectomy (TLPD) versus open pancreaticoduodenectomy (OPD) in patients with pancreatic carcinoma. It is a multicenter, prospective, randomized controlled trial involving 200 patients who will be allocated to either surgical group. The study focuses on evaluating overall survival rates while implementing an enhanced recovery after surgery (ERAS) protocol. The trial addresses the ongoing debate regarding the superiority of minimally invasive surgery compared to traditional open surgery for this aggressive cancer.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting

Study contacts

• Principal investigator: Renyi Qin — Tongji Hospital
• Study coordinator: Renyi Qin
• Email: 172356995@qq.com
• Phone: +8602783665314

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.