Pancreatic NeoplasmsPSMLOPDNCT05110573
Single-centre Propensity Score-matched Comparison of Laparoscopic Versus Open Pancreatoduodenectomy
An observational study of Pancreatic Neoplasms, run by General Hospital Groeninge at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- pancreatoduodenectomy
- Type of treatment
- Surgery or procedure
- How many people
- 172 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2000to 20 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Indications for surgery were benign or malignant lesions of the pancreatic head or peri-ampullary organs. All patients of ≥18 years old diagnosed with suspicious lesions located in the pancreas, ampulla, duodenum or distal bile duct were presented at the multidisciplinary oncological team. In case of biopsy-proven malignancy or clinical and radiological suspicion without confirmed malignancy, surgical resection was considered in accordance with contemporary guidelines
Who may be able to join
- diagnosis of lesion of pancreatic head or peri-ampullary organs
Who cannot join
- < 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Morbidity and Survival After Minimally Invasive Versus Open Pancreatoduodenectomy: Propensity Score Matched Comparison
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.
Read the detailed description
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.
- Conditions
- Pancreatic Neoplasms
- Being tested
- pancreatoduodenectomy
- Keywords
- pancreatoduodenectomy, minimally-invasive surgery, pancreatic cancer, chronic pancreatitis
- Medical subject headings
- Pancreatic Neoplasms, Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pancreatoduodenectomyProcedure or surgery
Patients included in the cohorts all underwent pancreatoduodenectomy, open or laparoscopic
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic pancreatoduodenectomy | Cohort of patients that underwent a Whipple-procedure through a laparoscopic approach. Receives: Procedure: pancreatoduodenectomy | |
| Open pancreatoduodenectomy | Cohort of patients that underwent a Whipple-procedure through a traditional open approach. Receives: Procedure: pancreatoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major complication rate
Complications classified as morbidity classification 3a or greater (Clavien-Dindo)
Measured: 90 days postoperative
Secondary outcomes (6)
Perioperative outcomes
Operative time (min), blood transfusion requirements, estimated blood loss (mL)
Measured: Up to 30 days
Short-term postoperative outcomes
Hospital stay (days), drain in situ (days), ICU stay (days)
Measured: Up to 30 days
Postoperative morbidity
All complications classified as morbidity classification 3a or greater (Clavien-Dindo)
Measured: 90 days
Pancreatectomy-specific complications
Postoperative pancreatic fistula, Post-pancreatectomy haemorrhage, delayed gastric emptying, as defined by the respective ISGPS classification
Measured: 90 days
Overall survival and disease-free survival
The Kaplan-Meier method was used for estimation of survival and compared between subgroups of cancer patients
Measured: Up to 20 years
Oncological outcomes
Analysis of resection specimen following contemporary pathlogy guidelines and defined by TNM staging system of pancreatic cancer by AJCC/UICC.
Measured: Up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start1 Jan 2000
- Primary completion31 Jan 2020
- Study completion20 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital Groeninge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. M. D'hondt, General Hospital Groeninge
- Investigators
- Mathieu D'Hondt, MD, Principal investigator, 1. Department of Digestive and Hepatobiliary/Pancreatic Surgery AZ Groeninge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05110573
- Sponsor's protocol ID
- B3962020000032
- Acronym
- PSMLOPD
- Status last verified
- Oct 2021
- First submitted
- 30 Aug 2021
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vandeputte M, Vansteenkiste F, Ceelen W, De Meyere C, D'Hondt M. Morbidity and survival after laparoscopic versus open pancreatoduodenectomy: propensity score matched comparison. Langenbecks Arch Surg. 2023 Jan 10;408(1):16. doi: 10.1007/s00423-023-02758-y.
PubMed 36624235
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morbidity and Survival After Minimally Invasive Versus Open Pancreatoduodenectomy: Propensity Score Matched Comparison
- ClinicalTrials.gov ID
- NCT05110573
- Acronym / sponsor ID
- PSMLOPD / B3962020000032
- Conditions
- Pancreatic Neoplasms
- Keywords
- pancreatoduodenectomy, minimally-invasive surgery, pancreatic cancer, chronic pancreatitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- General Hospital GroeningeUniversity, hospital or other
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 20 Mar 2021 (actual)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic pancreatoduodenectomy | – | Procedure: pancreatoduodenectomyCohort of patients that underwent a Whipple-procedure through a laparoscopic approach. |
| Open pancreatoduodenectomy | – | Procedure: pancreatoduodenectomyCohort of patients that underwent a Whipple-procedure through a traditional open approach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Indications for surgery were benign or malignant lesions of the pancreatic head or peri-ampullary organs. All patients of ≥18 years old diagnosed with suspicious lesions located in the pancreas, ampulla, duodenum or distal bile duct were presented at the multidisciplinary oncological team. In case of biopsy-proven malignancy or clinical and radiological suspicion without confirmed malignancy, surgical resection was considered in accordance with contemporary guidelines
Key inclusion criteria (1 listed)
- diagnosis of lesion of pancreatic head or peri-ampullary organs
Key exclusion criteria (1 listed)
- < 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pancreatoduodenectomyPatients included in the cohorts all underwent pancreatoduodenectomy, open or laparoscopic | Procedure or surgery | Laparoscopic pancreatoduodenectomy, Open pancreatoduodenectomy |
Primary outcome
Major complication rate
Time frame: 90 days postoperative
Complications classified as morbidity classification 3a or greater (Clavien-Dindo)
6 secondary outcomes
Perioperative outcomes
Time frame: Up to 30 days
Short-term postoperative outcomes
Time frame: Up to 30 days
Postoperative morbidity
Time frame: 90 days
Pancreatectomy-specific complications
Time frame: 90 days
Overall survival and disease-free survival
Time frame: Up to 20 years
Oncological outcomes
Time frame: Up to 20 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Derived from this study: PubMed 36624235Vandeputte M, Vansteenkiste F, Ceelen W, De Meyere C, D'Hondt M. Morbidity and survival after laparoscopic versus open pancreatoduodenectomy: propensity score matched comparison. Langenbecks Arch Surg. 2023 Jan 10;408(1):16. doi: 10.1007/s00423-023-02758-y.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathieu D'Hondt, MD principal investigator
1. Department of Digestive and Hepatobiliary/Pancreatic Surgery AZ Groeninge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Neoplasms, run by General Hospital Groeninge at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major complication rate (time frame: 90 days postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05110573, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.