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Comparison of Functional Recovery Between Laparoscopic and Open Pancreaticoduodenectomy

NCT03870698 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2023-02-27

No results posted yet for this study

Summary

Laparoscopic surgery has not changed much in safety compared with open surgery through many existing studies, and has become a procedure to help patients' recovery.

Recently, laparoscopic surgery has been actively performed for pancreaticoduodenectomy, one of the most complicated procedures in intraperitoneal surgery.

the investigators will perform a prospective study to establish a higher level of evidence for the efficacy and safety of laparoscopic pancreaticoduodenectomy.

The purpose of this study was to compare the short-term clinical outcomes including the functional recovery after surgery, complications and confirm that laparoscopic pancreaticoduodenectomy is safe and appropriate. This study includes an interim analysis and can be terminated early by analysis at the completion of 50% of planned patients.

Conditions

  • Functional Recovery
  • Laparoscopy
  • Periampullary Cancer

Interventions

PROCEDURE

Laparoscopic group

The patients in laparoscopic group will underwent pylorus preserving pancreaticoduodenectomy in laparoscopic manners.

Sponsors & Collaborators

  • Seoul National University Bundang Hospital

    collaborator OTHER

  • Severance Hospital

    collaborator OTHER

  • Samsung Medical Center

    collaborator OTHER

  • Hallym University Medical Center

    collaborator OTHER

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Song-Cheol Kim, MD, PhD · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-05-09
Primary Completion
2022-06-10
Completion
2022-08-31

Countries

  • South Korea

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 NCT03870698 on ClinicalTrials.gov