A Randomized Controlled Study on the Safety of Total Laparoscopy and Traditional Open Pancreaticoduodenectomy in the Treatment of Periampullary Tumors
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Beijing Friendship Hospital
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- Incidence of complications
Study Overview
Brief Summary
Pancreaticoduodenectomy (PD) is considered one of the most complex and dangerous procedures in general surgery. This procedure is the preferred surgical procedure for treating tumors around the ampulla. Traditional open pancreaticoduodenectomy (OPD) has brought great surgical trauma to patients while treating diseases. In 1994, Gagner et al first reported laparoscopic pancreaticoduodenectomy (LPD). With the development of laparoscopic techniques, the updating of devices, and the continuous accumulation of laparoscopic gastrointestinal surgery experience, the results of retrospective studies published show that there is no significant difference in safety between LPD and OPD. However, the results of the recently published RCT study show that the mortality associated with LPD complications is five times greater than that of OPD. At present, the security of LPD has been controversial. Therefore we conducted a prospective randomized controlled trial with a primary outcome of perioperative complications, providing evidence-based results for the safe and effective clinical development of LPD.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Preoperative imaging diagnosis of periampullary tumor, or preoperative pathological diagnosis of periampullary tumor, preoperative evaluation can be performed pancreaticoduodenectomy; Serum bilirubin was less than 100 μ mol/L before operation; Sign a written informed consent form and agree to be randomly divided into groups for surgical treatment.
Exclusion Criteria
- Not provided
Arms & Interventions
LPD
In this group, patients will undergo laparoscopic pancreaticoduodenectomy.
Intervention: laparoscopic pancreaticoduodenectomy (Procedure)
OPD
In this group, patients will undergo open pancreaticoduodenectomy.
Intervention: Open pancreaticoduodenectomy (Procedure)
Outcomes
Primary Outcomes
Incidence of complications
Time Frame: 30 days after operation
The patients number with complications / The total number in this group
Secondary Outcomes
No secondary outcomes reported
Investigators
Zhongtao Zhang
Chief Physician
Beijing Friendship Hospital