Vascular ResectionVR in RPDNCT07871045
Vascular Resection in Robotic Pancreaticoduodenectomy for Pancreatic Cancer
An observational study of Vascular Resection and Pancreatic Cancer, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Data for this propensity score-matched (PSM) comparative study were obtained from a prospectively maintained database comprising 679 cases of robotic pancreaticoduodenectomy (RPD). This study aimed to evaluate the feasibility and justification of vascular resection (VR) in RPD for pancreatic cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vascular Resection, Pancreatic Cancer, Robotic Pancreaticoduodenectomy
- What is being tested?
- vascular resection
- Type of treatment
- Surgery or procedure
- How many people
- 239 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jul 2025to 31 Dec 2025
- How long will I take part?
- 132 Months
- 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: Data for this propensity score-matched comparative study were obtained from a prospectively maintained database comprising 679 cases of RPD performed between July 2014 and August 2024. This study focused exclusively on patients with pancreatic head adenocarcinoma.
Who may be able to join
- Pancreatic cancer undergoing robotic pancreaticoduodenectomy
Who cannot join
- severe intra-abdominal adhesions
- extensive vascular encasement exceeding 2 cm
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
General Surgery, Taipei Veterans General Hospital
Taipei, Other, 11217
About this study
Official title: Vascular Resection in Robotic Pancreaticoduodenectomy for Pancreatic Cancer: a Propensity Score-matched Study
Data for this propensity score-matched (PSM) comparative study were obtained from a prospectively maintained database comprising 679 cases of robotic pancreaticoduodenectomy (RPD). This study aimed to evaluate the feasibility and justification of vascular resection (VR) in RPD for pancreatic cancer. The primary study endpoint was to compare the surgical outcomes between patients undergoing VR (+) and VR (-) in RPD using PSM to minimize selection bias and allow for balanced comparisons. The secondary study endpoint was to assess the impact of VR on oncological outcomes and overall survival in patients with pancreatic cancer undergoing RPD.
Read the detailed description
- Introduction Pancreaticoduodenectomy, commonly known as the Whipple procedure, was first described in 1935. Since then, it has become the standard surgical treatment for pancreatic head cancer. It is well established that curative resection with negative microscopic margins (R0 resection) is crucial for long-term survival. Unfortunately, fewer than 20% of patients present with resectable disease at diagnosis, as approximately 50% have distant metastases and 30-40% present with borderline resectable or locally advanced disease due to tumor involvement of major vessels such as the superior mesenteric vein (SMV), portal vein (PV), or superior mesenteric artery (SMA). Nevertheless, vascular involvement does not necessarily preclude curative surgery. In selected cases, pancreatic resection with en bloc resection of the PV-SMV confluence can achieve R0 resection. The first report of pancreaticoduodenectomy with PV-SMV resection was published by Moore, et al. in 1951[10]. Despite its technical feasibility, vascular resection (VR) remains a challenging extension to an already complex operation. It is often associated with increased perioperative morbidity and mortality, particularly in cases of extensive vascular involvement or when performed in low-volume centers. Moreover, the long-term survival benefit and likelihood of achieving R0 resection with VR continue to be subjects of ongoing debate. Recent advancements in chemotherapy and increased surgical expertise have led to more patients being considered eligible for curative resection, including those with borderline resectable or locally advanced disease previously deemed inoperable. Consequently, VR has gained wider acceptance and is now supported by expert consensus as a standard approach for pancreatic cancer with local vascular involvement. Pancreaticoduodenectomy remains one of the most technically demanding abdominal operations, requiring careful identification of complex vascular structures, meticulous dissection, and precise reconstruction, and, therefore, carrying a significant risk of surgical morbidity and mortality. Traditionally performed via an open approach, open pancreaticoduodenectomy (OPD), this operation is associated with significant postoperative pain, prolonged recovery, and large abdominal incisions. More recently, the advent of the da Vinci Robotic Surgical System (Intuitive Surgical®, Sunnyvale, CA, USA) has expanded the scope of minimally invasive surgery, including robotic pancreaticoduodenectomy (RPD). This platform offers enhanced dexterity, superior ergonomics, and improved visualization, which are particularly valuable for performing intricate dissections, suturing, and vascular reconstructions. While RPD presents unique challenges for VR compared to OPD, it also offers potential benefits such as reduced blood loss, less delayed gastric emptying, faster recovery, and improved cosmetic outcomes. In other words, providing it is done at high-volume centers, RPD is usually considered as safe as OPD, with some advantages in perioperative outcomes. Currently, the experience with VR in RPD remains limited, primarily due to a lack of large-scale studies. This study aimed to evaluate the feasibility and clinical justification of VR in the context of RPD for pancreatic cancer. To minimize selection bias, a comparison was conducted between patients undergoing RPD with and without VR, using propensity score matching (PSM) based on ten potential confounding variables related to surgical technique and survival outcomes. To date, this represents the first PSM-based study evaluating VR in RPD from a single high-volume center.
- Materials and Methods 2.1. Study population and design Data for this propensity score-matched comparative study were obtained from a prospectively maintained database comprising 679 cases of RPD performed between July 2014 and August 2024. This study focused exclusively on patients with pancreatic head adenocarcinoma. The research was retrospectively registered. In accordance with the Declaration of Helsinki, the research registration number was x, and it was registered at Chinese Clinical Trial Registry (ChiCTR), with a hyperlink to the registry entry by https://www.chictr.org.cn. The study protocol was approved by the Institutional Review Board (IRB) of Taipei Veterans General Hospital (IRB-TPEVGH No.: 2025-06-008BC). Informed consent was waived due to the retrospective and anonymized nature of the study. Patient selection for RPD was based on individual preference following detailed counseling regarding the benefits and risks of the robotic approach. Exclusion criteria included severe intra-abdominal adhesions and extensive vascular encasement exceeding 2 cm. In Taiwan, patients are responsible for the cost of robotic instruments, and RPD scheduling depends on the availability of the robotic system. Patients undergoing RPD for pancreatic cancer were categorized into two groups: those with VR and those without. Perioperative data, including demographic information, operative outcomes, pathological findings, and survival details, were prospectively collected and stored in the computer database for use in this propensity score-matched analysis.
2.2. Study endpoints This study aimed to evaluate the feasibility and justification of VR in RPD for pancreatic cancer. The primary study endpoint was to compare the surgical outcomes between patients undergoing VR (+) and VR (-) in RPD using PSM to minimize selection bias and allow for balanced comparisons. The secondary study endpoint was to assess the impact of VR on oncological outcomes and overall survival in patients with pancreatic cancer undergoing RPD.
2.3. Propensity score matching (PSM) strategy PSM was employed to reduce selection bias and facilitate equitable comparisons of treatment effects between the VR (+) and VR (-) groups in RPD. Individual propensity scores were calculated using logistic regression based on ten potential confounding variables related to surgical techniques and survival outcomes: (1) body mass index (BMI), (2) pancreatic parenchymal texture, (3) pancreatic duct diameter, (4) American Society of Anesthesiologists physical status (ASA-PS), (5) tumor size, (6) lymph node involvement, (7) perineural invasion, (8) lymphovascular invasion, (9) tumor differentiation, and (10) disease stage. Patients in the VR (+) and VR (-) groups were matched in a 1:1 ratio using nearest-neighbor matching based on the closest propensity scores. A caliper width of 0.05 standard deviations of the logit of the estimated propensity score was applied to ensure that observed differences in surgical and survival outcomes were attributable to the surgical intervention rather than baseline imbalances in prognostic factors.
2.4. Surgical technique All RPD procedures were performed by the same experienced pancreatic surgical team, led by senior surgeons Dr. Shyr Y.M. and Dr. Wang S.E. The da Vinci® Si or Xi system (Intuitive Surgical Inc., Sunnyvale, CA, USA) was used for all cases. The surgical technique was consistent across the cohort, with the only difference being the inclusion or exclusion of VR. Vascular reconstruction was performed using a continuous 5-0 Prolene suture. Open conversion through a 10-15 cm upper midline incision was undertaken in cases where technical difficulty arose during VR. Pancreatic reconstruction was carried out using the modified Blumgart pancreaticojejunostomy technique, as previously described in our published studies. In brief, patients were positioned supine with legs apart in the reverse Trendelenburg position. Temporary vascular cross-clamping of the superior mesenteric artery (SMA), superior mesenteric vein (SMV), and portal vein (PV) was performed using laparoscopic bulldog clamps (Aesculap Inc., Center Valley, PA, USA), controlled by the robotic ProGrasp Forceps™. Pancreatic duct stents were not routinely used, but soft silicone internal stents were selectively placed in cases with a non-dilated pancreatic duct. The final anastomosis, a hand-sewn gastrojejunostomy, was performed extracorporeally through a 3-6 cm umbilical incision, which also served as the extraction site for the surgical specimen. According to the Brescia consensus classification, this approach constitutes a type I combined robotic/open procedure.[20] Adjuvant chemotherapy was routinely administered within three months postoperatively, regardless of cancer stage, whenever the patient's condition permitted.
2.5. Definitions of surgical complications Postoperative pancreatic fistula (POPF) was defined as clinically relevant grade B or C, according to the 2016 revised grading system by the International Study Group on Pancreatic Fistula (ISGPF). Delayed gastric emptying (DGE), post-pancreatectomy hemorrhage (PPH), and chyle leak were classified based on the definitions established by the International Study Group of Pancreatic Surgery (ISGPS). The radicality of resection was categorized into three groups based on resection margin status: R0 resection, no gross or microscopic tumor within >1 mm of the resection margin; R1 resection, macroscopically negative but microscopically positive margin, with tumor cells present <1 mm from the margin; R2 resection, gross residual tumor at the resection margin. Surgical mortality was defined as any death occurring within 90 days postoperatively, including deaths during the initial hospitalization or any subsequent readmission. Postoperative complications were graded according to the Clavien-Dindo classification system.
2.6. Statistical analysis Statistical analyses were performed using SPSS version 26.0 (IBM Corp., Armonk, NY, USA). Categorical variables were expressed as absolute numbers and percentages, and compared using Pearson's chi-squared test or Fisher's exact test, as appropriate. Continuous variables were presented as median (range) or mean±standard deviation (SD), depending on data distribution. Group comparisons for continuous variables were conducted using the two-tailed Student's t-test for normally distributed data, and the Wilcoxon rank-sum test for non-normally distributed data. Overall survival was defined as the time from pancreatic resection to death from any cause or last follow-up. Survival curves were estimated using the Kaplan-Meier method and compared using the log-rank test. All tests were two-sided, and a p-value of < 0.05 was considered statistically significant.
- Being tested
- vascular resection
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vascular resectionProcedure or surgery
Vascular resection in robotic pancreaticoduodenectomy for pancreatic cancer
| Study group | Role | What they receive |
|---|---|---|
| pancreatic cancer | undergoing robotic pancreaticoduodenectomy Receives: Procedure: vascular resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary study endpoint was to compare the complication rates between patients undergoing vascular resection (VR) (+) and VR (-) in robotic pancreaticoduodenectomy (RPD).
using PSM to minimize selection bias and allow for balanced comparisons.
Measured: between July 2014 and August 2024
Secondary outcomes (1)
The secondary study endpoint was to assess the 1-year and 5-year patient survival rates after vascular resection (VR) in patients with pancreatic cancer undergoing robotic pancreaticoduodenectomy (RPD).
The secondary study endpoint was to assess the impact of vascular resection (VR) on the overall 1-year and 5-year patient survival rates patient survical rates for patients with pancreatic cancer undergoing robotic pancreaticoduodenectomy (RPD).
Measured: between July 2014 and August 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start1 Jul 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
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 Vascular ResectionStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 239 participants (actual)
- Target duration
- 132 Months
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871045
- Sponsor's protocol ID
- 2025-06-008BC
- Acronym
- VR in RPD
- Status last verified
- Oct 2026
- First submitted
- 25 Jun 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
[1] Whipple AO, Parsons WB, Mullins CR. Treatment of carcinoma of the ampulla of Vater. Ann Surg 1935;102(4):763-79. [2] Bellotti R, Aroori S, Cardini B, et al. Venous Resection During Pancreatoduodenectomy for Pancreatic Ductal Adenocarcinoma-A Multicentre Propensity Score Matching Analysis of the Recurrence After Whipple's (RAW) Study. Cancers (Basel) 2025;17(7). [3] Hackert T, Klaiber U, Hinz U, et al. Portal Vein Resection in Pancreatic Cancer Surgery: Risk of Thrombosis and Radicality Determine Survival. Ann Surg 2023;277(6):e1291-8. [4] Marino MV, Giovinazzo F, Podda M, et al. Robotic-assisted pancreaticoduodenectomy with vascular resection. Description of the surgical technique and analysis of early outcomes. Surg Oncol 2020;35:344-50. [5] Pedrazzoli S. Surgical Treatment of Pancreatic Cancer: Currently Debated Topics on Vascular Resection. Cancer Control 2023;30:10732748231153094. [6] Jeong HJ, Heo D, Lim SY, et al. Impact of portal/superior mesenteric vein abutment angle on prognosis in pancreatic cancer: a single-center retrospective cohort study. Ann Surg Treat Res 2025;108(4):231-9. [7] Serenari M, Ercolani G, Cucchetti A, et al. The impact of extent of pancreatic and venous resection on survival for patients with pancreatic cancer. Hepatobiliary Pancreat Dis Int 2019;18(4):389-94. [8] Ramacciato G, Nigri G, Petrucciani N, et al. Pancreatectomy with Mesenteric and Portal Vein Resection for Borderline Resectable Pancreatic Cancer: Multicenter Study of 406 Patients. Ann Surg Oncol 2016;23(6):2028-37. [9] Rahib L, Coffin T, Kenner B. Factors Driving Pancreatic Cancer Survival Rates. Pancreas 2025;1;54(6):e530-6. [10] Moore GE, Sako Y, Thomas LB. Radical pancreatoduodenectomy with resection and reanastomosis of the superior mesenteric vein. Surgery 1951;30(3):550-3. [11] Al Faraï A, Garnier J, Ewald J, et al. International Study Group of Pancreatic Surgery type 3 and 4 venous resections in patients with pancreatic adenocarcinoma:the Paoli-Calmettes Institute
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Resection in Robotic Pancreaticoduodenectomy for Pancreatic Cancer: a Propensity Score-matched Study
- ClinicalTrials.gov ID
- NCT07871045
- Acronym / sponsor ID
- VR in RPD / 2025-06-008BC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 13 Oct 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.
Data for this propensity score-matched (PSM) comparative study were obtained from a prospectively maintained database comprising 679 cases of robotic pancreaticoduodenectomy (RPD). This study aimed to evaluate the feasibility and justification of vascular resection (VR) in RPD for pancreatic cancer. The primary study endpoint was to compare the surgical outcomes between patients undergoing VR (+) and VR (-) in RPD using PSM to minimize selection bias and allow for balanced comparisons. The secondary study endpoint was to assess the impact of VR on oncological outcomes and overall survival in patients with pancreatic cancer undergoing RPD.
Detailed description
- Introduction Pancreaticoduodenectomy, commonly known as the Whipple procedure, was first described in 1935. Since then, it has become the standard surgical treatment for pancreatic head cancer. It is well established that curative resection with negative microscopic margins (R0 resection) is crucial for long-term survival. Unfortunately, fewer than 20% of patients present with resectable disease at diagnosis, as approximately 50% have distant metastases and 30-40% present with borderline resectable or locally advanced disease due to tumor involvement of major vessels such as the superior mesenteric vein (SMV), portal vein (PV), or superior mesenteric artery (SMA). Nevertheless, vascular involvement does not necessarily preclude curative surgery. In selected cases, pancreatic resection with en bloc resection of the PV-SMV confluence can achieve R0 resection. The first report of pancreaticoduodenectomy with PV-SMV resection was published by Moore, et al. in 1951[10]. Despite its technical feasibility, vascular resection (VR) remains a challenging extension to an already complex operation. It is often associated with increased perioperative morbidity and mortality, particularly in cases of extensive vascular involvement or when performed in low-volume centers. Moreover, the long-term survival benefit and likelihood of achieving R0 resection with VR continue to be subjects of ongoing debate. Recent advancements in chemotherapy and increased surgical expertise have led to more patients being considered eligible for curative resection, including those with borderline resectable or locally advanced disease previously deemed inoperable. Consequently, VR has gained wider acceptance and is now supported by expert consensus as a standard approach for pancreatic cancer with local vascular involvement. Pancreaticoduodenectomy remains one of the most technically demanding abdominal operations, requiring careful identification of complex vascular structures, meticulous dissection, and precise reconstruction, and, therefore, carrying a significant risk of surgical morbidity and mortality. Traditionally performed via an open approach, open pancreaticoduodenectomy (OPD), this operation is associated with significant postoperative pain, prolonged recovery, and large abdominal incisions. More recently, the advent of the da Vinci Robotic Surgical System (Intuitive Surgical®, Sunnyvale, CA, USA) has expanded the scope of minimally invasive surgery, including robotic pancreaticoduodenectomy (RPD). This platform offers enhanced dexterity, superior ergonomics, and improved visualization, which are particularly valuable for performing intricate dissections, suturing, and vascular reconstructions. While RPD presents unique challenges for VR compared to OPD, it also offers potential benefits such as reduced blood loss, less delayed gastric emptying, faster recovery, and improved cosmetic outcomes. In other words, providing it is done at high-volume centers, RPD is usually considered as safe as OPD, with some advantages in perioperative outcomes. Currently, the experience with VR in RPD remains limited, primarily due to a lack of large-scale studies. This study aimed to evaluate the feasibility and clinical justification of VR in the context of RPD for pancreatic cancer. To minimize selection bias, a comparison was conducted between patients undergoing RPD with and without VR, using propensity score matching (PSM) based on ten potential confounding variables related to surgical technique and survival outcomes. To date, this represents the first PSM-based study evaluating VR in RPD from a single high-volume center.
- Materials and Methods 2.1. Study population and design Data for this propensity score-matched comparative study were obtained from a prospectively maintained database comprising 679 cases of RPD performed between July 2014 and August 2024. This study focused exclusively on patients with pancreatic head adenocarcinoma. The research was retrospectively registered. In accordance with the Declaration of Helsinki, the research registration number was x, and it was registered at Chinese Clinical Trial Registry (ChiCTR), with a hyperlink to the registry entry by https://www.chictr.org.cn. The study protocol was approved by the Institutional Review Board (IRB) of Taipei Veterans General Hospital (IRB-TPEVGH No.: 2025-06-008BC). Informed consent was waived due to the retrospective and anonymized nature of the study. Patient selection for RPD was based on individual preference following detailed counseling regarding the benefits and risks of the robotic approach. Exclusion criteria included severe intra-abdominal adhesions and extensive vascular encasement exceeding 2 cm. In Taiwan, patients are responsible for the cost of robotic instruments, and RPD scheduling depends on the availability of the robotic system. Patients undergoing RPD for pancreatic cancer were categorized into two groups: those with VR and those without. Perioperative data, including demographic information, operative outcomes, pathological findings, and survival details, were prospectively collected and stored in the computer database for use in this propensity score-matched analysis.
2.2. Study endpoints This study aimed to evaluate the feasibility and justification of VR in RPD for pancreatic cancer. The primary study endpoint was to compare the surgical outcomes between patients undergoing VR (+) and VR (-) in RPD using PSM to minimize selection bias and allow for balanced comparisons. The secondary study endpoint was to assess the impact of VR on oncological outcomes and overall survival in patients with pancreatic cancer undergoing RPD.
2.3. Propensity score matching (PSM) strategy PSM was employed to reduce selection bias and facilitate equitable comparisons of treatment effects between the VR (+) and VR (-) groups in RPD. Individual propensity scores were calculated using logistic regression based on ten potential confounding variables related to surgical techniques and survival outcomes: (1) body mass index (BMI), (2) pancreatic parenchymal texture, (3) pancreatic duct diameter, (4) American Society of Anesthesiologists physical status (ASA-PS), (5) tumor size, (6) lymph node involvement, (7) perineural invasion, (8) lymphovascular invasion, (9) tumor differentiation, and (10) disease stage. Patients in the VR (+) and VR (-) groups were matched in a 1:1 ratio using nearest-neighbor matching based on the closest propensity scores. A caliper width of 0.05 standard deviations of the logit of the estimated propensity score was applied to ensure that observed differences in surgical and survival outcomes were attributable to the surgical intervention rather than baseline imbalances in prognostic factors.
2.4. Surgical technique All RPD procedures were performed by the same experienced pancreatic surgical team, led by senior surgeons Dr. Shyr Y.M. and Dr. Wang S.E. The da Vinci® Si or Xi system (Intuitive Surgical Inc., Sunnyvale, CA, USA) was used for all cases. The surgical technique was consistent across the cohort, with the only difference being the inclusion or exclusion of VR. Vascular reconstruction was performed using a continuous 5-0 Prolene suture. Open conversion through a 10-15 cm upper midline incision was undertaken in cases where technical difficulty arose during VR. Pancreatic reconstruction was carried out using the modified Blumgart pancreaticojejunostomy technique, as previously described in our published studies. In brief, patients were positioned supine with legs apart in the reverse Trendelenburg position. Temporary vascular cross-clamping of the superior mesenteric artery (SMA), superior mesenteric vein (SMV), and portal vein (PV) was performed using laparoscopic bulldog clamps (Aesculap Inc., Center Valley, PA, USA), controlled by the robotic ProGrasp Forceps™. Pancreatic duct stents were not routinely used, but soft silicone internal stents were selectively placed in cases with a non-dilated pancreatic duct. The final anastomosis, a hand-sewn gastrojejunostomy, was performed extracorporeally through a 3-6 cm umbilical incision, which also served as the extraction site for the surgical specimen. According to the Brescia consensus classification, this approach constitutes a type I combined robotic/open procedure.[20] Adjuvant chemotherapy was routinely administered within three months postoperatively, regardless of cancer stage, whenever the patient's condition permitted.
2.5. Definitions of surgical complications Postoperative pancreatic fistula (POPF) was defined as clinically relevant grade B or C, according to the 2016 revised grading system by the International Study Group on Pancreatic Fistula (ISGPF). Delayed gastric emptying (DGE), post-pancreatectomy hemorrhage (PPH), and chyle leak were classified based on the definitions established by the International Study Group of Pancreatic Surgery (ISGPS). The radicality of resection was categorized into three groups based on resection margin status: R0 resection, no gross or microscopic tumor within >1 mm of the resection margin; R1 resection, macroscopically negative but microscopically positive margin, with tumor cells present <1 mm from the margin; R2 resection, gross residual tumor at the resection margin. Surgical mortality was defined as any death occurring within 90 days postoperatively, including deaths during the initial hospitalization or any subsequent readmission. Postoperative complications were graded according to the Clavien-Dindo classification system.
2.6. Statistical analysis Statistical analyses were performed using SPSS version 26.0 (IBM Corp., Armonk, NY, USA). Categorical variables were expressed as absolute numbers and percentages, and compared using Pearson's chi-squared test or Fisher's exact test, as appropriate. Continuous variables were presented as median (range) or mean±standard deviation (SD), depending on data distribution. Group comparisons for continuous variables were conducted using the two-tailed Student's t-test for normally distributed data, and the Wilcoxon rank-sum test for non-normally distributed data. Overall survival was defined as the time from pancreatic resection to death from any cause or last follow-up. Survival curves were estimated using the Kaplan-Meier method and compared using the log-rank test. All tests were two-sided, and a p-value of < 0.05 was considered statistically significant.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 132 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pancreatic cancer | – | Procedure: vascular resectionundergoing robotic pancreaticoduodenectomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Data for this propensity score-matched comparative study were obtained from a prospectively maintained database comprising 679 cases of RPD performed between July 2014 and August 2024. This study focused exclusively on patients with pancreatic head adenocarcinoma.
Key inclusion criteria (1 listed)
- Pancreatic cancer undergoing robotic pancreaticoduodenectomy
Key exclusion criteria (2 listed)
- severe intra-abdominal adhesions
- extensive vascular encasement exceeding 2 cm
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 |
|---|---|---|
| vascular resectionVascular resection in robotic pancreaticoduodenectomy for pancreatic cancer | Procedure or surgery | pancreatic cancer |
Primary outcome
The primary study endpoint was to compare the complication rates between patients undergoing vascular resection (VR) (+) and VR (-) in robotic pancreaticoduodenectomy (RPD).
Time frame: between July 2014 and August 2024
using PSM to minimize selection bias and allow for balanced comparisons.
1 secondary outcome
The secondary study endpoint was to assess the 1-year and 5-year patient survival rates after vascular resection (VR) in patients with pancreatic cancer undergoing robotic pancreaticoduodenectomy (RPD).
Time frame: between July 2014 and August 2024
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 Oct 2026.
- Results publication[1] Whipple AO, Parsons WB, Mullins CR. Treatment of carcinoma of the ampulla of Vater. Ann Surg 1935;102(4):763-79. [2] Bellotti R, Aroori S, Cardini B, et al. Venous Resection During Pancreatoduodenectomy for Pancreatic Ductal Adenocarcinoma-A Multicentre Propensity Score Matching Analysis of the Recurrence After Whipple's (RAW) Study. Cancers (Basel) 2025;17(7). [3] Hackert T, Klaiber U, Hinz U, et al. Portal Vein Resection in Pancreatic Cancer Surgery: Risk of Thrombosis and Radicality Determine Survival. Ann Surg 2023;277(6):e1291-8. [4] Marino MV, Giovinazzo F, Podda M, et al. Robotic-assisted pancreaticoduodenectomy with vascular resection. Description of the surgical technique and analysis of early outcomes. Surg Oncol 2020;35:344-50. [5] Pedrazzoli S. Surgical Treatment of Pancreatic Cancer: Currently Debated Topics on Vascular Resection. Cancer Control 2023;30:10732748231153094. [6] Jeong HJ, Heo D, Lim SY, et al. Impact of portal/superior mesenteric vein abutment angle on prognosis in pancreatic cancer: a single-center retrospective cohort study. Ann Surg Treat Res 2025;108(4):231-9. [7] Serenari M, Ercolani G, Cucchetti A, et al. The impact of extent of pancreatic and venous resection on survival for patients with pancreatic cancer. Hepatobiliary Pancreat Dis Int 2019;18(4):389-94. [8] Ramacciato G, Nigri G, Petrucciani N, et al. Pancreatectomy with Mesenteric and Portal Vein Resection for Borderline Resectable Pancreatic Cancer: Multicenter Study of 406 Patients. Ann Surg Oncol 2016;23(6):2028-37. [9] Rahib L, Coffin T, Kenner B. Factors Driving Pancreatic Cancer Survival Rates. Pancreas 2025;1;54(6):e530-6. [10] Moore GE, Sako Y, Thomas LB. Radical pancreatoduodenectomy with resection and reanastomosis of the superior mesenteric vein. Surgery 1951;30(3):550-3. [11] Al Faraï A, Garnier J, Ewald J, et al. International Study Group of Pancreatic Surgery type 3 and 4 venous resections in patients with pancreatic adenocarcinoma:the Paoli-Calmettes Institute
- 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.
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 Vascular Resection and Pancreatic Cancer, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 2 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 Oct 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 Taiwan. 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?
The primary study endpoint was to compare the complication rates between patients undergoing vascular resection (VR) (+) and VR (-) in robotic pancreaticoduodenectomy (RPD). (time frame: between July 2014 and August 2024). 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 NCT07871045, 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 13 Oct 2026.