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Laparoscopic Pancreatoduodenectomy Versus Open Pancreatoduodenectomy

Minimally Invasive Versus Open for Pancreatoduodenectomy:an Retrospective, Observational, Multicenter Real-world Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05520606
Enrollment
800
Registered
2022-08-30
Start date
2014-01-01
Completion date
2021-12-30
Last updated
2022-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Resectable Lesions Located in the Pancreatic Head or Periampullary Region

Keywords

laparoscopic, minimally invasive, open resection, Pancreatoduodenectomy

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.

Detailed description

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.To date, how surgeons can safely pass the learning curve of laparoscopic pancreatoduodenectomy (LPD) without potentially harming patients remains a question. Around this topic, the investigators designed real-world study in a single center to retrospectively collect the PD surgeries since July 2014. 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. Besides, the investigators also want to investigate the clinical characteristics of patients and perioperative outcomes of LPD procedures and aimed to develop and validate a difficulty scoring system for patient selection which could help facilitate a comprehensive and security understanding of LPD for surgeon during different stage of the learning curve.

Interventions

PROCEDUREpancreatoduodenectomy

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

Sponsors

Tongji Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. Aged 18 to 80 years. 2. Patients underwent PD surgeries.

Exclusion criteria

1. Peritoneal seeding or metastasis to distant sites; 2. Incomplete clinical data.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative length of stayup to 90 daysdefined as the time from being admitted to hospital to discharge

Secondary

MeasureTime frameDescription
Operation timeintraoperativedefined as the time from skin incision or trocar placement to complete skin closure
postoperative complicationsup to 90 daysPostoperative complications were reviewed within 90 days after surgery and graded according to Clavien-Dindo (CD) classification system. Postoperative biliary leakage, hemorrhage, and liver failure. Wound infection was defined as purulent drainage from the incision or/and positive findings of culture of the fluid or tissue aseptically obtained from the incision.
Reoperation within 90 daysup to 90 daysdefined as any reoperation within 90 days
Overall survivalthrough study completion, an average of 5 yeardefined as the duration from the first day after surgery to either the date of death or the last follow-up
Readmission within 90 daysup to 90 daysdefined as any readmission within 90 days
R0 resectionintraoperativedefined as tumor-free margins in all the reported surgical margins (biliary and circumferential margins
Intraoperative blood lossintraoperativerecorded by the anesthetist using a vacuum system
Mortalityup to 90 daysdefined as any death within 30 days and 90 days, respectively

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026