Clinical trial NCT05520606: Laparoscopic Pancreatoduodenectomy Versus Open Pancreatoduodenectomy
Official title: Minimally Invasive Versus Open for Pancreatoduodenectomy：an Retrospective, Observational, Multicenter Real-world Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Resectable Lesions Located in the Pancreatic Head or Periampullary Region
Keywords: laparoscopic
minimally invasive
open resection
Pancreatoduodenectomy
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2022-08-30
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent PD surgeries in Tongji Hospital since January 2014 .

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative length of stay
timeFrame: up to 90 days
Secondary outcomes:
measure: Overall survival
timeFrame: through study completion, an average of 5 year
measure: Operation time
timeFrame: intraoperative
measure: postoperative complications
timeFrame: up to 90 days
measure: Reoperation within 90 days
timeFrame: up to 90 days
measure: Mortality
timeFrame: up to 90 days
measure: Readmission within 90 days
timeFrame: up to 90 days
measure: R0 resection
timeFrame: intraoperative
measure: Intraoperative blood loss
timeFrame: intraoperative
Other outcomes:
Locations:
Study officials:
References: