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OpenTrials
Completed

NCT Number: NCT05520606

Laparoscopic Pancreatoduodenectomy Versus Open Pancreatoduodenectomy

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.

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Key information

Conditions

Resectable Lesions Located in the Pancreatic Head or Periampullary Region

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Pancreatoduodenectomy

Procedure

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

Primary outcomes

  1. Postoperative length of stay

    Time frame: up to 90 days

    defined as the time from being admitted to hospital to discharge

Secondary outcomes

  1. Overall survival

    Time frame: through study completion, an average of 5 year

    defined as the duration from the first day after surgery to either the date of death or the last follow-up

  2. Operation time

    Time frame: intraoperative

    defined as the time from skin incision or trocar placement to complete skin closure

  3. postoperative complications

    Time frame: up to 90 days

    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.

  4. Reoperation within 90 days

    Time frame: up to 90 days

    defined as any reoperation within 90 days

  5. Mortality

    Time frame: up to 90 days

    defined as any death within 30 days and 90 days, respectively

  6. Readmission within 90 days

    Time frame: up to 90 days

    defined as any readmission within 90 days

  7. R0 resection

    Time frame: intraoperative

    defined as tumor-free margins in all the reported surgical margins (biliary and circumferential margins

  8. Intraoperative blood loss

    Time frame: intraoperative

    recorded by the anesthetist using a vacuum system

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2019
Study completion
2021
First posted
Aug 30, 2022
Registry last updated
Aug 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.