Postoperative ComplicationsCOSNALAPNCT05888129
Clinical Outcomes of Surgery After Neoadjuvant Chemotherapy in Locally Advanced Pancreatic Cancer
An observational study of Postoperative Complications, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study was to investigate the clinical outcomes of patients with locally advanced pancreatic cancer (LA-PC) who underwent surgery after neoadjuvant chemotherapy (NACT) at Asan Medical Center's Department of Hepato-Biliary-Pancreatic Surgery from 2017 to 2020. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- surgery after neoadjuvant chemotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2017to 31 Dec 2022
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We retrospectively reviewed records of patients who were diagnosed with resectable, borderline resectable, or locally advanced pancreatic adenocarcinoma between January 2017 and December 2020, at the Department of Surgery, Asan Medical Center, Seoul, South Korea. A total of 1,358 patients were diagnosed with pancreatic ductal adenocarcinoma and treated.
Who may be able to join
- The study population consists of patients who underwent pancreatectomy for pancreatic adenocarcinoma between January 2017 and December 2020
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcomes of Surgery After Neoadjuvant Chemotherapy in Locally Advanced Pancreatic Ductal Adenocarcinoma: is it Really Comparable to Borderline Resectable or Resectable Pancreatic Adenocarcinoma?
The purpose of this study was to investigate the clinical outcomes of patients with locally advanced pancreatic cancer (LA-PC) who underwent surgery after neoadjuvant chemotherapy (NACT) at Asan Medical Center's Department of Hepato-Biliary-Pancreatic Surgery from 2017 to 2020.
Read the detailed description
Pancreatic cancer (PC) has a very low survival rate. Most PC patients have non-specific symptoms that are advanced enough to be contraindications for surgical treatment; therefore, surgery is often impossible by the time PC is diagnosed. According to the NCCN guidelines, PCs with no metastases can be divided into resectable, borderline resectable , and locally advanced cases. Patients with borderline resectable PC (BR-PC) and locally advanced PC (LA-PC) currently receive multimodal therapy before surgery. The goal of these neoadjuvant treatments, including chemotherapy and radiation therapy, is to ultimately reduce local recurrence after surgery in patients with BR-PC and further improve their survival time. Additionally, several recent studies have reported results on the prognosis when surgery is performed after neoadjuvant chemotherapy (NACT) in patients with LA-PC. In the patients with LA-PC, surgery technically difficult because of major vascular invasion before NACT. Therefore, this study investigated the clinical outcomes of patients with LA-PC who underwent surgery after NACT. Additionally, the investigators evaluated factors affecting the prognosis related to survival after surgery in patients with LA-PC.
- Conditions
- Postoperative Complications
- Being tested
- surgery after neoadjuvant chemotherapy
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgery after neoadjuvant chemotherapyProcedure or surgery
surgery after neoadjuvant chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| locally advanced pancreatic cancer | Locally advanced pancreatic cancer (LA-PC) is classified according to the National Comprehansive Cancer Networks (NCCN) guidelines.
Patients with the above conditions underwent surgery after neoadjuvant chemotherapy. Receives: Procedure: surgery after neoadjuvant chemotherapy | |
| borderline resectable pancreatic cancer | Borderline resectable pancreatic cancer (BR-PC) is classified according to the NCCN guidelines.
Patients with the above conditions underwent surgery after neoadjuvant chemotherapy. Receives: Procedure: surgery after neoadjuvant chemotherapy | |
| resectable pancreatic cancer | Resectable pancreatic cancer (PC) is classified according to the NCCN guidelines. There are no arterial and venous contact with tumor Patients with the above conditions underwent upfront surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
oncologic outcome
overall survival and recurrence free survival according to the groups
Measured: 3 - 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start1 Jan 2017
- Primary completion31 Dec 2020
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Song Cheol Kim, Asan Medical Center
- Investigators
- Song Cheol Kim, MD. PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888129
- Sponsor's protocol ID
- 2016-0902
- Acronym
- COSNALAP
- Status last verified
- Jun 2023
- First submitted
- 9 May 2023
- Last updated
- 5 Jun 2023
- Results posted
- 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 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Surgery After Neoadjuvant Chemotherapy in Locally Advanced Pancreatic Ductal Adenocarcinoma: is it Really Comparable to Borderline Resectable or Resectable Pancreatic Adenocarcinoma?
- ClinicalTrials.gov ID
- NCT05888129
- Acronym / sponsor ID
- COSNALAP / 2016-0902
- Conditions
- Postoperative Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 5 Jun 2023 (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.
The purpose of this study was to investigate the clinical outcomes of patients with locally advanced pancreatic cancer (LA-PC) who underwent surgery after neoadjuvant chemotherapy (NACT) at Asan Medical Center's Department of Hepato-Biliary-Pancreatic Surgery from 2017 to 2020.
Detailed description
Pancreatic cancer (PC) has a very low survival rate. Most PC patients have non-specific symptoms that are advanced enough to be contraindications for surgical treatment; therefore, surgery is often impossible by the time PC is diagnosed. According to the NCCN guidelines, PCs with no metastases can be divided into resectable, borderline resectable , and locally advanced cases. Patients with borderline resectable PC (BR-PC) and locally advanced PC (LA-PC) currently receive multimodal therapy before surgery. The goal of these neoadjuvant treatments, including chemotherapy and radiation therapy, is to ultimately reduce local recurrence after surgery in patients with BR-PC and further improve their survival time. Additionally, several recent studies have reported results on the prognosis when surgery is performed after neoadjuvant chemotherapy (NACT) in patients with LA-PC. In the patients with LA-PC, surgery technically difficult because of major vascular invasion before NACT. Therefore, this study investigated the clinical outcomes of patients with LA-PC who underwent surgery after NACT. Additionally, the investigators evaluated factors affecting the prognosis related to survival after surgery in patients with LA-PC.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| locally advanced pancreatic cancer | – | Procedure: surgery after neoadjuvant chemotherapyLocally advanced pancreatic cancer (LA-PC) is classified according to the National Comprehansive Cancer Networks (NCCN) guidelines. Patients with the above conditions underwent surgery after neoadjuvant chemotherapy. |
| borderline resectable pancreatic cancer | – | Procedure: surgery after neoadjuvant chemotherapyBorderline resectable pancreatic cancer (BR-PC) is classified according to the NCCN guidelines. Patients with the above conditions underwent surgery after neoadjuvant chemotherapy. |
| resectable pancreatic cancer | – | –Resectable pancreatic cancer (PC) is classified according to the NCCN guidelines. There are no arterial and venous contact with tumor Patients with the above conditions underwent upfront surgery |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We retrospectively reviewed records of patients who were diagnosed with resectable, borderline resectable, or locally advanced pancreatic adenocarcinoma between January 2017 and December 2020, at the Department of Surgery, Asan Medical Center, Seoul, South Korea. A total of 1,358 patients were diagnosed with pancreatic ductal adenocarcinoma and treated.
Key inclusion criteria (1 listed)
- The study population consists of patients who underwent pancreatectomy for pancreatic adenocarcinoma between January 2017 and December 2020
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| surgery after neoadjuvant chemotherapysurgery after neoadjuvant chemotherapy | Procedure or surgery | borderline resectable pancreatic cancer, locally advanced pancreatic cancer |
Primary outcome
oncologic outcome
Time frame: 3 - 5 years after surgery
overall survival and recurrence free survival according to the groups
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 5 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Postoperative Complications
Recruiting
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
Anastomotic Leaks, Hartmanns Stump Leakage
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
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.
Song Cheol Kim, MD. PhD principal investigator
Asan Medical Center
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 Postoperative Complications, run by Asan Medical Center at 1 site in South Korea.
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 5 Jun 2023. 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 South Korea. 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?
oncologic outcome (time frame: 3 - 5 years after surgery). 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 5 Jun 2023.