Trials / Recruiting
RecruitingNCT03747588
The Comparision of Minimally-invasive and Open Pancreaticoduodenectomy for Pancreatic Cancer
The Effect and Safety of Comparision Between Minimally-invasive and Open Pancreaticoduodenectomy for Pancreatic Cancer : A Randomized Prospective Trial
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Peking Union Medical College Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Minimally invasive pancreaticoduodenectomy remains one of the most challenging abdominal procedures. Safety and feasibility remain controversial when comparing minimally-invasive with open pancreaticoduodenectomy, especially for malignant tumors.The aim of this study was to compare minimally invasive and open pancreatoduodenectomy for short-term outcomes and long-term follow-up in a randomized trial.
Detailed description
This study is to compare the efficiency and safety between minimally invasive (including laparoscopic and robotic) and open pancreaticoduodenectomy for pancreatic cancer. We design a prospective randomized study. Patients with malignant pancreatic tumor who underwent pancreatoduodenectomy are recruited to the study. After obtaining informed consent, eligible patients are randomly allocated to minimally-invasive or open group before the operation day. The outcomes evaluated were hospital stay, and blood loss, radicality of surgery, duration of operation and complication rate as well as disease free survival and overall survival.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Minimally-invasive pancreaticoduodenectomy | Minimally-invasive pancreaticoduodenectomy for resection of pancreatic tumor |
| OTHER | Open pancreaticoduodenectomy | Open pancreaticoduodenectomy for resection of pancreatic tumor |
Timeline
- Start date
- 2018-12-01
- Primary completion
- 2023-12-01
- Completion
- 2028-12-30
- First posted
- 2018-11-20
- Last updated
- 2022-10-03
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03747588. Inclusion in this directory is not an endorsement.