Distal Pancreatectomy (DP)PREINSTRUCTNCT07338409
Evaluation of Postoperative Outcomes and Mortality in Laparoscopic and Robotic Distal Pancreatectomy
An observational study of Distal Pancreatectomy (DP), run by Jessa Hospital at 1 site in Belgium.
Trial summary
Minimally invasive distal pancreatectomy can be performed using either a laparoscopic or robotic approach. These minimally invasive techniques are becoming increasingly common in the surgical treatment of both benign and malignant pancreatic lesions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Distal Pancreatectomy (DP)
- How many people
- 126 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Mar 2025to 5 Jun 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients that underwent distal pancreatectomy surgery at Jessa Hospital from 01/01/2020 up until 31/12/2024 were included in the study.
Who may be able to join
- Underwent distal pancreatectomy surgery at Jessa Hospital from 01/01/2020 up until 31/12/2024.
Who cannot join
- Underwent open procedure
- Restpancreatectomy
- Central pancreatectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Postoperative Outcomes and Mortality in Laparoscopic and Robotic Distal Pancreatectomy: a Retrospective Single-center Analysis
Minimally invasive distal pancreatectomy can be performed using either a laparoscopic or robotic approach. These minimally invasive techniques are becoming increasingly common in the surgical treatment of both benign and malignant pancreatic lesions. They offer several advantages over traditional open surgery, such as less postoperative pain, better cosmetic results, faster recovery, less blood loss during surgery, and lower healthcare costs. However, despite these advantages, evidence comparing postoperative outcomes, particularly complications, between laparoscopic and robotic distal pancreatectomy remains limited.
Previous studies suggest that robotic surgery may offer technical benefits, such as greater accuracy and precision, which could potentially result in fewer complications. However, the available literature is diverse and often based on small cohorts.
Read the detailed description
Aim The aim of this study is to evaluate and compare the occurrence and severity of postoperative complications in the 90-day post-operative period between patients undergoing laparoscopic and robotic distal pancreatectomy.
Design A single center retrospective cohort study analysis of patients that underwent distal pancreatectomy surgery at Jessa Hospital from 01/01/2020 up until 30/06/2025.
Sample size All patients that underwent distal pancreatectomy surgery at Jessa Hospital from 01/01/2020 up until 30/06/2025 were included in the study. This were 103 patients.
Study population
Inclusion and exclusion criteria:
All patients that underwent distal pancreatectomy surgery at Jessa Hospital from 01/01/2020 up until 30/06/2025
Primary outcome To to evaluate and compare the occurrence and severity of postoperative complications in the 90-day post-operative period between patients undergoing laparoscopic and robotic distal pancreatectomy.
Secondary outcome measurements Secondary outcome measurements include the evaluation of the Comprehensive Complication Index (CCI), the conversion rates, length of hospital stays, readmission rates, mortality, and the number of lymph nodes harvested. Potential differences in medical costs will also be assessed.
Statistical analysis All data will be transferred from the platform into SPSS Version 28. For descriptive purposes, continuous data are shown as mean ± standard deviation (SD) or median (IQR) for nonnormally distributed data, and categorical data are presented as frequencies (%). For comparative analyses, the Chi-square or Fisher's exact test will be used for categorial variables, and the Independent t-test or Mann-Whitney U test for continuous variables. To assess the primary objective, a bivariate logistic regression model will be used. A P-value <0.05 was considered statistically significant.
Additional collected parameters that are not part of the mandatory registration for complex pancreatic surgery in Belgium are listed below:
- All relevant direct medical costs (e.g., consultation fees and medication) that arise from inpatient care provision will be collected using the financial records of the Jessa Hospital
Additional collected parameters are listed below and are collected as part of the mandatory registration for complex pancreatic surgery in Belgium in the Belgian Cancer Registry (BCR), specifically the "Complex Pancreatic Surgery" registration module:
- Administrative and demographic data
- Referral
- Clinical indication and diagnosis
- Diagnostic procedures
- Comorbidities
- Use of antithrombotic medication
- Neoadjuvant treatment
- Surgery details
- Postoperative outcomes
- Adjuvant therapy
- Conditions
- Distal Pancreatectomy (DP)
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day postoperative complications
Postoperative in-hospital complications in the 90-day postoperative period
Measured: 90- days postoperative
Secondary outcomes (7)
Cumulative postoperative morbidity
Cumulative postoperative morbidity, quantified using the Comprehensive Complication Index (CCI), which integrates all complications weighted by severity
Measured: Patients that underwent distal pancreatectomy surgery at Jessa Hospital from 01/01/2020 up until 30/06/2025
Length of hospital stay
Length of stay (days) starting from the moment of surgery
Measured: Time between start of surgery and discharge of hospital
Re-admissions
Re-admission within 30 days of discharge (from the center that performed the surgery)
Measured: within 30 days of discharge
Conversion rate
The rate at which planned minimally invasive surgeries (laparoscopic/robotic) are converted to open surgeries
Measured: Time from surgery until last follow up of the study
Mortality
Mortality up until 31/12/2025
Measured: Until the end of the study (31/12/2025)
Lymph nodes harvested
The number of lymph nodes that were retrieved during surgery
Measured: During surgery
Medical costs
Potential differences in medical costs will be assessed by means of a health-economic analysis.
Measured: From surgery until end of the study (31/12/2025)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start4 Mar 2025
- Primary completion5 Jun 2025
- Study completion5 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Pancreatectomy (DP)Studies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stessel Björn, Jessa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07338409
- Sponsor's protocol ID
- 2025/109
- Acronym
- PREINSTRUCT
- Status last verified
- Jan 2026
- First submitted
- 16 Dec 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Postoperative Outcomes and Mortality in Laparoscopic and Robotic Distal Pancreatectomy: a Retrospective Single-center Analysis
- ClinicalTrials.gov ID
- NCT07338409
- Acronym / sponsor ID
- PREINSTRUCT / 2025/109
- Conditions
- Distal Pancreatectomy (DP)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 5 Jun 2025 (actual)
- Study completion
- 5 Jun 2025 (actual)
- First posted
- 13 Jan 2026 (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 distal pancreatectomy can be performed using either a laparoscopic or robotic approach. These minimally invasive techniques are becoming increasingly common in the surgical treatment of both benign and malignant pancreatic lesions. They offer several advantages over traditional open surgery, such as less postoperative pain, better cosmetic results, faster recovery, less blood loss during surgery, and lower healthcare costs. However, despite these advantages, evidence comparing postoperative outcomes, particularly complications, between laparoscopic and robotic distal pancreatectomy remains limited.
Previous studies suggest that robotic surgery may offer technical benefits, such as greater accuracy and precision, which could potentially result in fewer complications. However, the available literature is diverse and often based on small cohorts.
Detailed description
Aim The aim of this study is to evaluate and compare the occurrence and severity of postoperative complications in the 90-day post-operative period between patients undergoing laparoscopic and robotic distal pancreatectomy.
Design A single center retrospective cohort study analysis of patients that underwent distal pancreatectomy surgery at Jessa Hospital from 01/01/2020 up until 30/06/2025.
Sample size All patients that underwent distal pancreatectomy surgery at Jessa Hospital from 01/01/2020 up until 30/06/2025 were included in the study. This were 103 patients.
Study population
Inclusion and exclusion criteria:
All patients that underwent distal pancreatectomy surgery at Jessa Hospital from 01/01/2020 up until 30/06/2025
Primary outcome To to evaluate and compare the occurrence and severity of postoperative complications in the 90-day post-operative period between patients undergoing laparoscopic and robotic distal pancreatectomy.
Secondary outcome measurements Secondary outcome measurements include the evaluation of the Comprehensive Complication Index (CCI), the conversion rates, length of hospital stays, readmission rates, mortality, and the number of lymph nodes harvested. Potential differences in medical costs will also be assessed.
Statistical analysis All data will be transferred from the platform into SPSS Version 28. For descriptive purposes, continuous data are shown as mean ± standard deviation (SD) or median (IQR) for nonnormally distributed data, and categorical data are presented as frequencies (%). For comparative analyses, the Chi-square or Fisher's exact test will be used for categorial variables, and the Independent t-test or Mann-Whitney U test for continuous variables. To assess the primary objective, a bivariate logistic regression model will be used. A P-value <0.05 was considered statistically significant.
Additional collected parameters that are not part of the mandatory registration for complex pancreatic surgery in Belgium are listed below:
- All relevant direct medical costs (e.g., consultation fees and medication) that arise from inpatient care provision will be collected using the financial records of the Jessa Hospital
Additional collected parameters are listed below and are collected as part of the mandatory registration for complex pancreatic surgery in Belgium in the Belgian Cancer Registry (BCR), specifically the "Complex Pancreatic Surgery" registration module:
- Administrative and demographic data
- Referral
- Clinical indication and diagnosis
- Diagnostic procedures
- Comorbidities
- Use of antithrombotic medication
- Neoadjuvant treatment
- Surgery details
- Postoperative outcomes
- Adjuvant therapy
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients that underwent distal pancreatectomy surgery at Jessa Hospital from 01/01/2020 up until 31/12/2024 were included in the study.
Key inclusion criteria (1 listed)
- Underwent distal pancreatectomy surgery at Jessa Hospital from 01/01/2020 up until 31/12/2024.
Key exclusion criteria (3 listed)
- Underwent open procedure
- Restpancreatectomy
- Central pancreatectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
90-day postoperative complications
Time frame: 90- days postoperative
Postoperative in-hospital complications in the 90-day postoperative period
7 secondary outcomes
Cumulative postoperative morbidity
Time frame: Patients that underwent distal pancreatectomy surgery at Jessa Hospital from 01/01/2020 up until 30/06/2025
Length of hospital stay
Time frame: Time between start of surgery and discharge of hospital
Re-admissions
Time frame: within 30 days of discharge
Conversion rate
Time frame: Time from surgery until last follow up of the study
Mortality
Time frame: Until the end of the study (31/12/2025)
Lymph nodes harvested
Time frame: During surgery
Medical costs
Time frame: From surgery until end of the study (31/12/2025)
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 13 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Distal Pancreatectomy (DP)
RecruitingObservational study
Feasibility and Effectiveness of Three-day Discharge After Distal Pancreatectomy
Pancreatic Neoplasms, Distal Pancreatectomy (DP)
Not yet recruitingObservational study
European Appleby Registry for Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
Recruiting
Laparoscopic Versus Robot-assisted Left-sided Pancreatectomy for Benign and Pre-malignant Lesions (DIPLOMA-3)
Pancreatectomy, Distal Pancreatectomy (DP)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Distal Pancreatectomy (DP), run by Jessa Hospital 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 3 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 13 Jan 2026. 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?
90-day postoperative complications (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?
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 13 Jan 2026.