Laparoscopic, Pancreatic Carcinoma, Pancreaticoduodenectomy
Conditions
Keywords
Pancreatic Carcinoma, Laparoscopic, Pancreaticoduodenectomy, Survival
Brief summary
Background: Pancreatic cancer (PC) is one of the most aggressive malignant neoplasms with poor outcomes. Pancreatoduodenectomy (PD) is the only curative treatment for PC. Minimally invasive surgery has been progressively developed, first with the advent of hybrid-laparoscopy and recently with the total laparoscopy surgeries, but a number of issues are currently being debated, including the superiority between total laparoscopic pancreaticoduodenectomy (TLPD)and the open pancreaticoduodenectomy (OPD). Studies comparing these two surgery techniques are merging and randomized controlled trials (RCT) are lacking but clearly required. Methods/design: TJDBPS07 is a multicenter prospective, randomized controlled, trial comparing TLPD and OPD in pancreatic cancers. A total of 200 patients with pancreatic cancer underwent PD will be randomly allocated to the TLPD group or OPD group with an enhanced recovery after surgery (ERAS) pattern. The trial's aim is to exploring the overall survival (OS), disease free survival (DFS) and quality of life. The duration of the entire trial is seven years including prearrangement, a presumably five-year follow-up and analyses. Discussion: Despite the fact there are several RCTs comparing minimally invasive pancreaticoduodenectomy (MIPD) and Open approach or LPD versus OPD. This trial will be the first comparing TLPD and OPD in a large multicenter setting. TJDBPS01 trial is hypothesized to assess whether TLPD has superiority over OPD in recovery and other aspects.
Interventions
PROCEDURETLPD Surgery
TLPD
PROCEDUREOPD Surgery
OPD
Sponsors
Shandong Provincial Hospital
The Second Hospital of Hebei Medical University
The Affiliated Hospital of Xuzhou Medical University
Xinqiao Hospital of Chongqing
Hunan Provincial People's Hospital
The First Hospital of Jilin University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
The Third Affiliated Hospital of Soochow University
Guangdong Provincial Hospital of Traditional Chinese Medicine
Affiliated Hospital of North Sichuan Medical College
First Affiliated Hospital of Chongqing Medical University
Peking Union Medical College Hospital
Henan Provincial People's Hospital
Sir Run Run Shaw Hospital
Fujian Medical University Union Hospital
Fudan University
Tongji Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 5-year overall survival | 5 year | 5-year overall survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| disease-free survival | 5 years | the interval between the day of surgery and the day of tumour recurrence |
| 90-day mortality | 90 days | the percentage of patients who died within 90 days postoperatively |
| complication rate | 90 days | complications related to PD |
| overall survival | 5 years | the interval between the day of surgery and the day of death for various reasons |
| length of stay | 90 days | the number of nights spent in the hospital from the end of the surgical procedure until discharge or death |
| intraoperative indicators | 90 days | description of the patients' intraoperative condition relating to the safety of patients |
| comprehensive complication index | 90 days | calculated as the sum of all complications that are weighted for their severity |
Countries
China
Contacts
Primary ContactRenyi Qin
Backup ContactHag Zhang
Outcome results
None listed