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

NCT04037982 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2019-07-30

No results posted yet for this study

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.

Conditions

  • Periampullary Tumor
  • Complication
  • Death
  • Survival

Interventions

PROCEDURE

laparoscopic pancreaticoduodenectomy

During laparoscopic surgery, the surgeon makes several smaller incisions in your abdomen and inserts special instruments, including a camera that transmits video to a monitor in the operating room. The surgeon watches the monitor to guide the surgical tools in performing the Whipple procedure. Laparoscopic surgery is a type of minimally invasive surgery.

PROCEDURE

Open pancreaticoduodenectomy

During an open procedure, your surgeon makes an incision in your abdomen in order to access your pancreas. This is the most common approach and the most studied.

Sponsors & Collaborators

  • Beijing Friendship Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-31
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04037982 on ClinicalTrials.gov