NCT03785743Recruiting
Comparing Laparoscopic and Open Surgery for Pancreatic Carcinoma
Total Laparoscopic Pancreaticoduodenectomy Versus Open Pancreaticoduodenectomy for Pancreatic Carcinoma(TJDBPS07) a Multicenter Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 2 Mar 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 20 Dec 2018
- Start date
- 1 Mar 2019
- Primary completion date
- 1 Mar 2027
- Lead sponsor
- Tongji Hospital
- Diseases
- Pancreatic cancer
- NCT number
- NCT03785743
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 1 Mar 2019 to the primary completion date, 1 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients requiring left, central or total pancreatectomy or other palliative surgery.
- Patients treated with neoadjuvant therapy.
- Patients with vascular invasion and requiring vascular resection as evaluated by the MDT team according to abdominal imaging data.
Other illness
- History of other malignant disease.
- Patients with serious mental disorders.
Other
- Patients with distant metastases, including peritoneal, liver, distant lymph node metastases, and involvement of other organs.
- Preoperative American Society of Anaesthesiologists (ASA) score ≥ 4.
- Pregnant or breast-feeding women.
- Body mass index \> 35 kg/m2.
- Patients participating in any other clinical trials within 3 months.
Who the study is looking for
- Age between 18 years and 75 years.
- Histologically confirmed PDAC or clinically diagnosed PDAC by an MDT without histopathologic evidence.
- Patients feasible to undergo both LPD and OPD according to MDT evaluations.
- Patients understanding and willing to comply with this trial.
- Provision of written informed consent before patient registration.
- Patients meeting the curative treatment intent in accordance with clinical guidelines.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.