Comparing two surgical methods for pancreatic cancer treatment
Total Laparoscopic Pancreaticoduodenectomy Versus Open Pancreaticoduodenectomy for Pancreatic Carcinoma(TJDBPS07) a Multicenter Randomized Controlled Trial
This study is testing if a less invasive surgery for pancreatic cancer works better than traditional surgery in helping patients live longer after treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT03785743 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 with histologically confirmed or clinically diagnosed pancreatic ductal adenocarcinoma who are eligible for both surgical techniques.
Not a fit: Patients with distant metastases, severe comorbidities, or those requiring palliative surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into which surgical approach offers better survival outcomes for patients with pancreatic cancer.
How similar studies have performed: While studies comparing laparoscopic and open surgery exist, this trial is significant as it is a randomized controlled trial specifically designed to address the lack of robust evidence in this area.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Wuhan, Hubei
- 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
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.