Clinical trial · Interventional
RCT Study on Safety of LPD and OPD in the Treatment of Periampullary Tumors
A Randomized Controlled Study on the Safety of Total Laparoscopy and Traditional Open Pancreaticoduodenectomy in the Treatment of Periampullary Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Complication | — | UNRESOLVED | — |
| Death | — | UNRESOLVED | — |
| Periampullary Tumor | — | UNRESOLVED | — |
| Survival | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laparoscopic pancreaticoduodenectomy | Procedure | — | UNRESOLVED |
| Open pancreaticoduodenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- LPD
- description
- In this group, patients will undergo laparoscopic pancreaticoduodenectomy.
- interventionNames
- Procedure: laparoscopic pancreaticoduodenectomy
- type
- ACTIVE_COMPARATOR
- label
- OPD
- description
- In this group, patients will undergo open pancreaticoduodenectomy.
- interventionNames
- Procedure: Open pancreaticoduodenectomy
Primary outcomes (1)
- measure
- Incidence of complications
- timeFrame
- 30 days after operation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available