NCT05520606

Brief Summary

This is a single, retrospective, real-world study to investigate the surgical outcomes of minimally invasive pancreatoduodenectomy and open pancreatoduodenectomy, with the perioperative characteristics and long-term overall survival being compared. The investigators aimed to find out whether the minimally invasive surgery is safe and feasible for resectable lesions located in the pancreatic head and periampullary region. And the investigators also want to find out patients with what kind of characteristic can be benefit from the minimally invasive surgery compared with the open approach.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 30, 2022

Completed
Last Updated

August 30, 2022

Status Verified

August 1, 2022

Enrollment Period

6 years

First QC Date

August 19, 2022

Last Update Submit

August 29, 2022

Conditions

Keywords

laparoscopicminimally invasiveopen resectionPancreatoduodenectomy

Outcome Measures

Primary Outcomes (1)

  • Postoperative length of stay

    defined as the time from being admitted to hospital to discharge

    up to 90 days

Secondary Outcomes (8)

  • Overall survival

    through study completion, an average of 5 year

  • Operation time

    intraoperative

  • postoperative complications

    up to 90 days

  • Reoperation within 90 days

    up to 90 days

  • Mortality

    up to 90 days

  • +3 more secondary outcomes

Study Arms (2)

minimally invasive surgery

laparoscopic pancreatoduodenectomy.

Procedure: pancreatoduodenectomy

open surgery

open pancreatoduodenectomy

Procedure: pancreatoduodenectomy

Interventions

Pancreatoduodenectomy (Whipple surgery) is a complex surgical procedure and has been accepted as the gold standard treatment for resectable lesions of the pancreatic head and periampullary region

minimally invasive surgeryopen surgery

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent PD surgeries in Tongji Hospital since January 2014 .

You may qualify if:

  • Aged 18 to 80 years.
  • Patients underwent PD surgeries.

You may not qualify if:

  • Peritoneal seeding or metastasis to distant sites;
  • Incomplete clinical data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Pancreaticoduodenectomy

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Surgery, Chief Physician, Director of Surgical Supervision Department, Deputy Director of Institute of Hepatobiliary&Pancreatic, Director of Department of Biliary-Pancreatic Surgery

Study Record Dates

First Submitted

August 19, 2022

First Posted

August 30, 2022

Study Start

January 1, 2014

Primary Completion

December 30, 2019

Study Completion

December 30, 2021

Last Updated

August 30, 2022

Record last verified: 2022-08