Pancreatic NeoplasmsNCT07821775
Robotic vs Laparoscopic and Open Surgery for Abdominopelvic Cancers
An observational study of Pancreatic Neoplasms and Stomach Neoplasms, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Robotic surgery has become an increasingly common option for treating cancers in the abdomen and pelvis. However, whether robotic surgery leads to better cancer-related outcomes than laparoscopic (keyhole) surgery or open surgery is still uncertain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms, Stomach Neoplasms, Rectal Neoplasms
- How many people
- 32,949 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2012to 31 Dec 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Adults aged 18 years or older who underwent curative-intent abdominopelvic surgery for one of seven nonmetastatic malignant solid tumors (pancreatic, gastric, rectal, cervical, endometrial, kidney, or prostate cancer) at Asan Medical Center, a large tertiary referral center in Seoul, Republic of Korea, between January 1, 2012, and December 31, 2021.
Who may be able to join
- Age 18 years or older
- Underwent curative-intent abdominopelvic surgery for a nonmetastatic malignant solid tumor of one of the following types: pancreatic, gastric, rectal, cervical, endometrial, kidney, or prostate cancer
- Surgery performed between January 1, 2012, and December 31, 2021
- Available postoperative surveillance data
Who cannot join
- Presence of distant metastasis before surgery
- Presentation with recurrent disease from previously treated cancer
- Incomplete or missing key demographic, comorbidity, operative, or outcome data required for analysis
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Asan Medical Center, University of Ulsan College of Medicine
Seoul, Songpa-gu, 05505
About this study
Official title: Early Oncologic and Perioperative Outcomes of Robotic Surgery Across Seven Abdominopelvic Malignancies
Robotic surgery has become an increasingly common option for treating cancers in the abdomen and pelvis. However, whether robotic surgery leads to better cancer-related outcomes than laparoscopic (keyhole) surgery or open surgery is still uncertain. Results may differ across cancer types, and factors such as how complex the surgery is and how experienced the surgeon is may also influence the outcome.
This retrospective cohort study examined adults who underwent curative-intent surgery for one of seven abdominopelvic cancers (pancreatic, gastric, rectal, cervical, endometrial, kidney, or prostate cancer) at a large tertiary hospital in Seoul, South Korea, between January 2012 and December 2021. Patients were classified into three groups according to the surgical approach they received: open, laparoscopic, or robotic surgery.
Read more
The main outcome was 1-year disease-free survival, defined as the time from surgery to the first occurrence of cancer recurrence, distant metastasis, or death from any cause. Additional outcomes included 1-year mortality, overall mortality during follow-up, major postoperative complications, acute kidney injury, and length of hospital stay.
To reduce differences between groups that might affect the comparison, the study used a statistical method called propensity score overlap weighting. Additional analyses adjusted for surgical complexity, surgeon experience including robotic learning curve, and pathological cancer stage to isolate the effect of the surgical platform itself.
The purpose of this study was to evaluate whether the association between surgical approach and early oncologic and perioperative outcomes differed across the seven cancer types, and whether any observed advantage of the robotic platform remained after accounting for these factors.
Read the detailed description
Study Design This was a single-center, retrospective cohort study conducted at Asan Medical Center, a large tertiary referral center in Seoul, Republic of Korea. The study protocol was approved by the Institutional Review Board of Asan Medical Center (approval number 2026-0316), and the requirement for written informed consent was waived due to the retrospective design. The study is reported in accordance with the Strengthening the Reporting of Cohort, Cross-sectional and Case-control Studies in Surgery (STROCSS) guideline.
Study Population Adults aged 18 years or older who underwent curative-intent abdominopelvic surgery for one of seven nonmetastatic malignant solid tumors (pancreatic, gastric, rectal, cervical, endometrial, kidney, or prostate cancer) between January 1, 2012, and December 31, 2021 were considered eligible. Patients were excluded if they had distant metastasis before surgery, presented with recurrent disease from previously treated cancer, or had incomplete key demographic, comorbidity, operative, or outcome data.
Exposure Patients were classified into three groups according to the surgical approach: open surgery, laparoscopic surgery, and robotic surgery. Two pairwise cohorts were constructed for comparative effectiveness analyses: (1) open versus robotic surgery for all seven cancer types, and (2) laparoscopic versus robotic surgery for six cancer types (prostate cancer excluded due to absence of laparoscopic prostatectomy at the study institution during the study period).
Primary Outcome
1-year disease-free survival (DFS), defined as the interval from surgery to the first occurrence of cancer recurrence, distant metastasis, or death from any cause. The 1-year time horizon was selected because postoperative oncologic surveillance was systematically available during the first postoperative year across the included malignancies.
Secondary Outcomes
- 1-year all-cause mortality
- Overall mortality during the entire follow-up period
- Major postoperative complications within 30 days (composite of cardiovascular events, stroke, venous thromboembolism, pneumonia, wound dehiscence, systemic infection, sepsis, acute kidney injury, and urinary tract infection)
- Postoperative acute kidney injury (KDIGO criteria)
- Hospital length of stay
Statistical Analysis Propensity scores were estimated separately for each pairwise comparison within each cancer type using multivariable logistic regression, incorporating demographics, tumor stage, surgical factors, comorbidities, preoperative medications, and laboratory measurements. Overlap weights were applied to emphasize patients with substantial covariate overlap without trimming. Time-to-event outcomes were analyzed using weighted Cox proportional hazards models with robust variance estimation. Pooled estimates across cancer types were obtained from models stratified by cancer type, with heterogeneity assessed by interaction testing. Binary outcomes were analyzed using Firth penalized logistic regression, and length of stay using weighted linear regression after log transformation. E-values were computed to assess sensitivity to unmeasured confounding.
Sensitivity Analyses A stepwise doubly robust strategy was applied. Model 1 was the primary overlap-weighted analysis. Model 2 additionally adjusted for surgical complexity (European Society of Cardiology surgical risk category and cancer-specific operation subtypes) and provider-level factors including cumulative robotic experience of the operating surgeon as a proxy for the robotic learning curve. Model 3 further adjusted for pathological severity (advanced T stage, nodal involvement, and FIGO stage where applicable) among patients with available staging.
- Conditions
- Pancreatic Neoplasms, Stomach Neoplasms, Rectal Neoplasms, Uterine Cervical Neoplasms, Endometrial Neoplasms, Kidney Neoplasms
- Being tested
- No Intervention: Observational Cohort
- Keywords
- Robotic Surgery, Laparoscopic Surgery, Open Surgery, Oncologic Outcomes
- Medical subject headings
- Pancreatic Neoplasms, Stomach Neoplasms, Rectal Neoplasms, Uterine Cervical Neoplasms, Endometrial Neoplasms, Kidney Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
Participants underwent curative-intent surgery for abdominopelvic malignancies (pancreatic, gastric, rectal, cervical, endometrial, kidney, or prostate cancer) and were followed retrospectively without any experimental intervention. The surgical approach (open, laparoscopic, or robotic) was determined by routine clinical practice, not by study protocol. Data were extracted from the institutional electronic medical record system and linked with national administrative data for outcome ascertainment.
| Study group | Role | What they receive |
|---|---|---|
| Open Surgery | Adults who underwent curative-intent abdominopelvic cancer surgery via open (laparotomy) approach for one of seven cancer types (pancreatic, gastric, rectal, cervical, endometrial, kidney, or prostate cancer) between January 2012 and December 2021. Receives: Other: No Intervention: Observational Cohort | |
| Laparoscopic Surgery | Adults who underwent curative-intent abdominopelvic cancer surgery via conventional laparoscopic approach for one of six cancer types (pancreatic, gastric, rectal, cervical, endometrial, or kidney cancer) between January 2012 and December 2021. Laparoscopic prostatectomy was not performed at the study institution during the study period. Receives: Other: No Intervention: Observational Cohort | |
| Robotic Surgery | Adults who underwent curative-intent abdominopelvic cancer surgery via robotic-assisted (da Vinci) approach for one of seven cancer types (pancreatic, gastric, rectal, cervical, endometrial, kidney, or prostate cancer) between January 2012 and December 2021. Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-Year Disease-Free Survival
Time from surgery to the first occurrence of cancer recurrence, distant metastasis, or death from any cause, censored at 1 year. Recurrence and metastasis were confirmed radiologically or pathologically. Patients without an event were censored at the last postoperative surveillance encounter.
Measured: 1 year after surgery
Secondary outcomes (5)
1-Year All-Cause Mortality
Death from any cause within 1 year after surgery, ascertained through linked national administrative data.
Measured: 1 year after surgery
Overall All-Cause Mortality During Follow-up
Death from any cause during the entire follow-up period, ascertained through linked national administrative data.
Measured: From date of surgery to date of death or end of follow-up, assessed up to approximately 10 years
Major Postoperative Complications Within 30 Days
Composite of cardiovascular events, stroke, venous thromboembolism, pneumonia, wound dehiscence, systemic infection, sepsis, acute kidney injury (KDIGO criteria), and urinary tract infection occurring within 30 days after surgery.
Measured: Within 30 days after surgery
Postoperative Acute Kidney Injury
Acute kidney injury within 7 days after surgery, defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria based on changes in serum creatinine from preoperative baseline.
Measured: Within 7 days after surgery
Hospital Length of Stay
Number of days from the index operation to hospital discharge.
Measured: From date of surgery to date of hospital discharge, up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start1 Jan 2012
- Primary completion31 Dec 2022
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies 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
- 32,949 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji-Hoon Sim, Asan Medical Center
- Investigators
- Ji-Hoon Sim, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07821775
- Sponsor's protocol ID
- AMC [2026-0316]
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Oncologic and Perioperative Outcomes of Robotic Surgery Across Seven Abdominopelvic Malignancies
- ClinicalTrials.gov ID
- NCT07821775
- Acronym / sponsor ID
- AMC [2026-0316]
- Conditions
- Pancreatic Neoplasms, Stomach Neoplasms, Rectal Neoplasms, Uterine Cervical Neoplasms, Endometrial Neoplasms, Kidney Neoplasms
- Keywords
- Robotic Surgery, Laparoscopic Surgery, Open Surgery, Oncologic Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32,949 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 16 Sep 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.
Robotic surgery has become an increasingly common option for treating cancers in the abdomen and pelvis. However, whether robotic surgery leads to better cancer-related outcomes than laparoscopic (keyhole) surgery or open surgery is still uncertain. Results may differ across cancer types, and factors such as how complex the surgery is and how experienced the surgeon is may also influence the outcome.
This retrospective cohort study examined adults who underwent curative-intent surgery for one of seven abdominopelvic cancers (pancreatic, gastric, rectal, cervical, endometrial, kidney, or prostate cancer) at a large tertiary hospital in Seoul, South Korea, between January 2012 and December 2021. Patients were classified into three groups according to the surgical approach they received: open, laparoscopic, or robotic surgery.
The main outcome was 1-year disease-free survival, defined as the time from surgery to the first occurrence of cancer recurrence, distant metastasis, or death from any cause. Additional outcomes included 1-year mortality, overall mortality during follow-up, major postoperative complications, acute kidney injury, and length of hospital stay.
To reduce differences between groups that might affect the comparison, the study used a statistical method called propensity score overlap weighting. Additional analyses adjusted for surgical complexity, surgeon experience including robotic learning curve, and pathological cancer stage to isolate the effect of the surgical platform itself.
The purpose of this study was to evaluate whether the association between surgical approach and early oncologic and perioperative outcomes differed across the seven cancer types, and whether any observed advantage of the robotic platform remained after accounting for these factors.
Detailed description
Study Design This was a single-center, retrospective cohort study conducted at Asan Medical Center, a large tertiary referral center in Seoul, Republic of Korea. The study protocol was approved by the Institutional Review Board of Asan Medical Center (approval number 2026-0316), and the requirement for written informed consent was waived due to the retrospective design. The study is reported in accordance with the Strengthening the Reporting of Cohort, Cross-sectional and Case-control Studies in Surgery (STROCSS) guideline.
Study Population Adults aged 18 years or older who underwent curative-intent abdominopelvic surgery for one of seven nonmetastatic malignant solid tumors (pancreatic, gastric, rectal, cervical, endometrial, kidney, or prostate cancer) between January 1, 2012, and December 31, 2021 were considered eligible. Patients were excluded if they had distant metastasis before surgery, presented with recurrent disease from previously treated cancer, or had incomplete key demographic, comorbidity, operative, or outcome data.
Exposure Patients were classified into three groups according to the surgical approach: open surgery, laparoscopic surgery, and robotic surgery. Two pairwise cohorts were constructed for comparative effectiveness analyses: (1) open versus robotic surgery for all seven cancer types, and (2) laparoscopic versus robotic surgery for six cancer types (prostate cancer excluded due to absence of laparoscopic prostatectomy at the study institution during the study period).
Primary Outcome
1-year disease-free survival (DFS), defined as the interval from surgery to the first occurrence of cancer recurrence, distant metastasis, or death from any cause. The 1-year time horizon was selected because postoperative oncologic surveillance was systematically available during the first postoperative year across the included malignancies.
Secondary Outcomes
- 1-year all-cause mortality
- Overall mortality during the entire follow-up period
- Major postoperative complications within 30 days (composite of cardiovascular events, stroke, venous thromboembolism, pneumonia, wound dehiscence, systemic infection, sepsis, acute kidney injury, and urinary tract infection)
- Postoperative acute kidney injury (KDIGO criteria)
- Hospital length of stay
Statistical Analysis Propensity scores were estimated separately for each pairwise comparison within each cancer type using multivariable logistic regression, incorporating demographics, tumor stage, surgical factors, comorbidities, preoperative medications, and laboratory measurements. Overlap weights were applied to emphasize patients with substantial covariate overlap without trimming. Time-to-event outcomes were analyzed using weighted Cox proportional hazards models with robust variance estimation. Pooled estimates across cancer types were obtained from models stratified by cancer type, with heterogeneity assessed by interaction testing. Binary outcomes were analyzed using Firth penalized logistic regression, and length of stay using weighted linear regression after log transformation. E-values were computed to assess sensitivity to unmeasured confounding.
Sensitivity Analyses A stepwise doubly robust strategy was applied. Model 1 was the primary overlap-weighted analysis. Model 2 additionally adjusted for surgical complexity (European Society of Cardiology surgical risk category and cancer-specific operation subtypes) and provider-level factors including cumulative robotic experience of the operating surgeon as a proxy for the robotic learning curve. Model 3 further adjusted for pathological severity (advanced T stage, nodal involvement, and FIGO stage where applicable) among patients with available staging.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Open Surgery | – | Other: No Intervention: Observational CohortAdults who underwent curative-intent abdominopelvic cancer surgery via open (laparotomy) approach for one of seven cancer types (pancreatic, gastric, rectal, cervical, endometrial, kidney, or prostate cancer) between January 2012 and December 2021. |
| Laparoscopic Surgery | – | Other: No Intervention: Observational CohortAdults who underwent curative-intent abdominopelvic cancer surgery via conventional laparoscopic approach for one of six cancer types (pancreatic, gastric, rectal, cervical, endometrial, or kidney cancer) between January 2012 and December 2021. Laparoscopic prostatectomy was not performed at the study institution during the study period. |
| Robotic Surgery | – | Other: No Intervention: Observational CohortAdults who underwent curative-intent abdominopelvic cancer surgery via robotic-assisted (da Vinci) approach for one of seven cancer types (pancreatic, gastric, rectal, cervical, endometrial, kidney, or prostate cancer) between January 2012 and December 2021. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 years or older who underwent curative-intent abdominopelvic surgery for one of seven nonmetastatic malignant solid tumors (pancreatic, gastric, rectal, cervical, endometrial, kidney, or prostate cancer) at Asan Medical Center, a large tertiary referral center in Seoul, Republic of Korea, between January 1, 2012, and December 31, 2021.
Key inclusion criteria (4 listed)
- Age 18 years or older
- Underwent curative-intent abdominopelvic surgery for a nonmetastatic malignant solid tumor of one of the following types: pancreatic, gastric, rectal, cervical, endometrial, kidney, or prostate cancer
- Surgery performed between January 1, 2012, and December 31, 2021
- Available postoperative surveillance data
Key exclusion criteria (3 listed)
- Presence of distant metastasis before surgery
- Presentation with recurrent disease from previously treated cancer
- Incomplete or missing key demographic, comorbidity, operative, or outcome data required for analysis
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 |
|---|---|---|
| No Intervention: Observational CohortParticipants underwent curative-intent surgery for abdominopelvic malignancies (pancreatic, gastric, rectal, cervical, endometrial, kidney, or prostate cancer) and were followed retrospectively without any experimental intervention. The surgical approach (open, laparoscopic, or robotic) was determined by routine clinical practice, not by study protocol. Data were extracted from the institutional electronic medical record system and linked with national administrative data for outcome ascertainment. | Other | Laparoscopic Surgery, Open Surgery, Robotic Surgery |
Primary outcome
1-Year Disease-Free Survival
Time frame: 1 year after surgery
Time from surgery to the first occurrence of cancer recurrence, distant metastasis, or death from any cause, censored at 1 year. Recurrence and metastasis were confirmed radiologically or pathologically. Patients without an event were censored at the last postoperative surveillance encounter.
5 secondary outcomes
1-Year All-Cause Mortality
Time frame: 1 year after surgery
Overall All-Cause Mortality During Follow-up
Time frame: From date of surgery to date of death or end of follow-up, assessed up to approximately 10 years
Major Postoperative Complications Within 30 Days
Time frame: Within 30 days after surgery
Postoperative Acute Kidney Injury
Time frame: Within 7 days after surgery
Hospital Length of Stay
Time frame: From date of surgery to date of hospital discharge, up to 90 days
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 16 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Ji-Hoon Sim, 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 Pancreatic Neoplasms and Stomach Neoplasms, 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 4 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 16 Sep 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 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?
1-Year Disease-Free Survival (time frame: 1 year 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 16 Sep 2026.