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OpenTrials
Completed

NCT Number: NCT05110573

Single-centre Propensity Score-matched Comparison of Laparoscopic Versus Open Pancreatoduodenectomy

Minimally invasive pancreatoduodenectomy is increasingly performed. However, technical challenges and a perceived higher risk of complications has hindered wide adoption of a minimally invasive approach.

This is a retrospective comparison of a prospectively kept database. The investigators compared surgical outcomes and survival after laparoscopic (LPD) versus open pancreatoduodenectomy (OPD). In order to reduce the effect of bias and confounding, baseline characteristics of both groups were matched using propensity score matching.

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Key information

Conditions

Pancreatic Neoplasms Chronic Disease Digestive System Diseases Digestive System Neoplasms Disease Attributes Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatitis Pancreatitis, Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

General Hospital Groeninge

Kortrijk, 8500, Belgium

About this study

All pancreatoduodenectomies were retrieved from a prospectively kept database and retrospectively analysed. All procedures were performed in a single supra-regional Belgian centre.

The primary endpoint was the major complication rate, defined by a Clavien-Dindo morbidity classification grade IIIa or higher [11]. Secondary endpoints were 90-day mortality rate, length of hospital stay, operative time, blood loss, transfusion requirements and specific pancreatic complications (pancreatic fistula, haemorrhage, and delayed gastric emptying). In addition, overall survival (OS) and disease-free survival (DFS) were analysed in the subgroups of cancer patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diagnosis of lesion of pancreatic head or peri-ampullary organs

Exclusion criteria

  • < 18 years old

Treatment and study plan

Pancreatoduodenectomy

Procedure

Patients included in the cohorts all underwent pancreatoduodenectomy, open or laparoscopic

Primary outcomes

  1. Major complication rate

    Time frame: 90 days postoperative

    Complications classified as morbidity classification 3a or greater (Clavien-Dindo)

Secondary outcomes

  1. Perioperative outcomes

    Time frame: Up to 30 days

    Operative time (min), blood transfusion requirements, estimated blood loss (mL)

  2. Short-term postoperative outcomes

    Time frame: Up to 30 days

    Hospital stay (days), drain in situ (days), ICU stay (days)

  3. Postoperative morbidity

    Time frame: 90 days

    All complications classified as morbidity classification 3a or greater (Clavien-Dindo)

  4. Pancreatectomy-specific complications

    Time frame: 90 days

    Postoperative pancreatic fistula, Post-pancreatectomy haemorrhage, delayed gastric emptying, as defined by the respective ISGPS classification

  5. Overall survival and disease-free survival

    Time frame: Up to 20 years

    The Kaplan-Meier method was used for estimation of survival and compared between subgroups of cancer patients

  6. Oncological outcomes

    Time frame: Up to 20 years

    Analysis of resection specimen following contemporary pathlogy guidelines and defined by TNM staging system of pancreatic cancer by AJCC/UICC.

Sponsors and collaborators

Lead sponsor

General Hospital Groeninge

Other

Registry information

Official study title

Morbidity and Survival After Minimally Invasive Versus Open Pancreatoduodenectomy: Propensity Score Matched Comparison

Acronym: PSMLOPD

Important dates

Study start
2000
Primary completion
2020
Study completion
2021
First posted
Nov 8, 2021
Registry last updated
Nov 8, 2021

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.

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