Laparoscopic Pancreatoduodenectomy Versus Open Pancreatoduodenectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Resectable Lesions Located in the Pancreatic Head or Periampullary Region
• Intervention / Treatment: Procedure: pancreatoduodenectomy

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.

• Study Type: Observational
• Enrollment (Actual): 800

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
minimally invasive surgery; laparoscopic pancreatoduodenectomy.	Procedure: pancreatoduodenectomy; 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
open surgery; open pancreatoduodenectomy	Procedure: pancreatoduodenectomy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative length of stay	defined as the time from being admitted to hospital to discharge	up to 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	defined as the duration from the first day after surgery to either the date of death or the last follow-up	through study completion, an average of 5 year
Operation time	defined as the time from skin incision or trocar placement to complete skin closure	intraoperative
postoperative complications	Postoperative 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.	up to 90 days
Reoperation within 90 days	defined as any reoperation within 90 days	up to 90 days
Mortality	defined as any death within 30 days and 90 days, respectively	up to 90 days
Readmission within 90 days	defined as any readmission within 90 days	up to 90 days
R0 resection	defined as tumor-free margins in all the reported surgical margins (biliary and circumferential margins	intraoperative
Intraoperative blood loss	recorded by the anesthetist using a vacuum system	intraoperative

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): December 30, 2019
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: August 19, 2022
• First Submitted That Met QC Criteria: August 29, 2022
• First Posted (Actual): August 30, 2022

Study Record Updates

• Last Update Posted (Actual): August 30, 2022
• Last Update Submitted That Met QC Criteria: August 29, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: laparoscopic; minimally invasive; Pancreatoduodenectomy; open resection
• Other Study ID Numbers: TJDBPS11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No