RCT Study on Safety of LPD and OPD in the Treatment of Periampullary Tumors

Not Applicable

• Conditions: Death; Periampullary Tumor; Survival; Complication
• Interventions: Procedure: laparoscopic pancreaticoduodenectomy; Procedure: Open pancreaticoduodenectomy

• Registration Number: NCT04037982
• Lead Sponsor: Beijing Friendship Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-07
• Study First Submitted: 2019-07-28
• Study First Submitted QC: 2019-07-28
• Last Update Submitted: 2019-07-28
• Study First Posted: 2019-07-30
• Last Update Posted: 2019-07-30
• Study Start: 2019-08
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LPD	laparoscopic pancreaticoduodenectomy	In this group, patients will undergo laparoscopic pancreaticoduodenectomy.
OPD	Open pancreaticoduodenectomy	In this group, patients will undergo open pancreaticoduodenectomy.

Primary Outcome Measures

Name	Time	Method
Incidence of complications	30 days after operation	The patients number with complications / The total number in this group

Trial Locations

Locations (1)

Beijing Friendship Hospital, Capital medical University; 🇨🇳 Beijing, China