Pancreatic AdenocarcinomaPORTALNCT04400357
Robotic Versus Open Pancreaticoduodenectomy for Pancreatic and Periampullary Tumors
A study testing Robotic pancreaticoduodenectomy and Open pancreaticoduodenectomy in people with Pancreatic Adenocarcinoma and Pancreatic Cysts, run by Ruijin Hospital at 1 site in China.
Trial summary
This multicenter randomized trial aims to primarily assess and compare the functional recovery of patients who undergo open versus robotic pancreaticoduodenectomy for benign and malignant lesions of the head of the pancreas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma, Pancreatic Cysts, Pancreatic Endocrine Tumors
- What is being tested?
- Robotic pancreaticoduodenectomy and Open pancreaticoduodenectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 1 siteChina
- Study dates
- 28 Sep 2020to 28 Feb 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with an indication for elective pancreaticoduodenectomy for malignant, premalignant, and symptomatic benign disease in the pancreatic and periampullary region
- Performance status of 0/1 (assessed based on comorbidities using the Karnofsky score and Malnutrition Universal Screening Tool score among others, especially for patients with malignant disease)
- Imaging with computed tomography and/or MRI pancreas performed within 8 weeks for benign and 4 weeks for malignant disease; for the latter tumor staging with MRI liver, CT chest, and Cancer Antigen 19-9 is also mandatory.
Who cannot join
- Body mass index > 35 kg/m2
- Pregnancy
- Previous history of major abdominal surgery
- Requirement for multivisceral resection (additional surgical resection)
- Preoperative chemotherapy and/or radiotherapy (for patients with pancreatic adenocarcinoma)
- Involvement of major regional vessels by the tumor (portal and superior mesenteric vein, superior mesenteric artery, hepatic artery, celiac artery) as defined by the borderline resectable and locally advanced nomenclature
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
Official title: Robotic Versus Open Pancreaticoduodenectomy for Pancreatic and Periampullary Tumors: A Multicenter Phase III Non-Inferiority Randomized Controlled Trial
This multicenter randomized trial aims to primarily assess and compare the functional recovery of patients who undergo open versus robotic pancreaticoduodenectomy for benign and malignant lesions of the head of the pancreas.
Read the detailed description
The PORTAL trial is a Phase 3 multicenter non-inferiority randomized controlled trial that aims to address the question of feasibility and efficacy of the robotic minimally invasive approach in pancreaticoduodenectomy.
In the past 10 years there has been an increasing number of retrospective series from major centers for pancreatic surgery worldwide, that demonstrate similar and occasionally improved postoperative outcomes in patients who undergo a robotic pancreaticoduodenectomy (Whipple). The benefits of this minimally invasive approach appear to be decreased intraoperative estimated blood loss, lower postoperative pain levels and smaller length of hospital stay, whereas postoperative complications rates are comparable with the standard open approach.
This trial is conducted in multiple major centers for pancreatic surgery (open and robotic) in China and aims to address these questions in a prospective fashion. All eligible patients who present to these centers within the study period will be randomized in a 1:1 ratio to either of the two arms (open vs. robotic). Patients enrolled in the study will be blinded regarding the type of the procedure by application of identical wound dressings at the trocar sites and the open incision. Patients will be followed up closely and will be evaluated routinely for quality of life parameters for a period of at least 2 years postoperatively. Additionally, patients who undergo surgery in either arm for pancreatic adenocarcinoma will also be evaluated for time to adjuvant chemotherapy postoperatively, as well as recurrence and survival data.
- Conditions
- Pancreatic Adenocarcinoma, Pancreatic Cysts, Pancreatic Endocrine Tumors, Chronic Pancreatitis, Cholangiocarcinoma, Extrahepatic, Ampullary Adenocarcinoma
- Being tested
- Robotic pancreaticoduodenectomy, Open pancreaticoduodenectomy
- Keywords
- pancreaticoduodenectomy, Whipple, robotic, daVinci, pancreatic cancer, outcomes, pancreatectomy, functional recovery, complications, recurrence, circulating tumor DNA, perioperative inflammation
- Medical subject headings
- Pancreatic Cyst, Pancreatitis, Chronic, Cholangiocarcinoma, Pancreatic Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic pancreaticoduodenectomyProcedure or surgery
Patients in this arm will undergo a pancreaticoduodenectomy with robotic-assisted techonology.
Open pancreaticoduodenectomyProcedure or surgery
Patients in this arm will undergo an open pancreaticoduodenectomy which is the standard surgical approach.
| Study group | Role | What they receive |
|---|---|---|
| Robotic pancreaticoduodenectomy | Experimental | Patients randomized in this arm will undergo a robotic pancreaticoduodenectomy. Receives: Procedure: Robotic pancreaticoduodenectomy |
| Open pancreaticoduodenectomy | Active comparator | Patients randomized in this arm will undergo a routine open pancreaticoduodenectomy. Receives: Procedure: Open pancreaticoduodenectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to functional recovery postoperatively
Daily evaluation of patient postoperative course will take place by the nursing and medical staff and will be documented by the study coordinators. Postoperative criteria that need to be fulfilled independently to achieve functional recovery status are the following:
- Discontinuation of intravenous or subcutaneous analgesia and preservation of adequate control levels (pain score)
- Early ambulation and restoration of mobility to an independent level (or to preoperative level if previously impaired)
- Ability to maintain sufficient oral caloric intake as defined by institutional dietitian services, without intravenous fluid support
- No clinical signs of active abdominal infection affecting the patient's performance status: absence of fever, white cell count and C-reactive protein decreasing towards normalization. The patient can be in oral antibiotics.
Measured: From date of surgery to date of functional recovery as described, assessed up to 90 days.
Secondary outcomes (11)
Intraoperative blood loss
Comparison of estimated blood loss (in ml)
Measured: During surgery
Operative time
Comparison of operative time (in minutes, from first incision to skin closure)
Measured: During surgery
Percentage of patients with pancreatic adenocarcinoma who achieve administration of adjuvant chemotherapy at 8 weeks postoperatively
The number of patients who are fit and well to initiate adjuvant chemotherapy at the 8-week mark after the operation will be documented and compared between the two arms
Measured: Postoperative Day 1 to Day 56
Postoperative complication rates and associated interventions
Comparison of post-pancreatectomy morbidity between the two surgical approaches, that focus on:
- Pancreatic fistula
- Bile leak
- Chyle leak
- Delayed gastric emptying
- Surgical site infection
- Postoperative pancreatitis
- Postoperative hemorrhage
- Surgical site infections
- Other complications Additional documentation of re-intervention (radiological, endoscopic, or surgical) and re-admission rates, as well as postoperative hospital and ICU length of stay (time to discharge)
Measured: Postoperative Day 1 to Day 30
Postoperative mortality
Comparison of mortality rates as a result of the pancreaticoduodenectomy in each arm
Measured: Postoperative Day 1 to Day 90
Quality of life measurements
For assessment of postoperative quality of life (QoL) improvement, patients will be evaluated with the established EuqoQol EQ-5D-5L questionnaire, which is a self-reported assay focusing on five parameters: Pain/discomfort, anxiety/depression, usual activities, self-care, and mobility. Each of the five aforementioned parameters is scored from 0 to 5 (no issue, slight problem, moderate problem, severe problem, unable); patients also score independently their health status on a scale numbered from 0 to 100; 100 means the best health they can imagine, and 0 the worst.
Answered questionnaires will be collected on postoperative days 1, 3, 5, 7, and afterwards every week until day 30. QoL evaluation will terminate at Day 90.
Measured: Postoperative Day 1 to Day 90
Margin resection status (R) in patients with pancreatic adenocarcinoma
In a sub-cohort of patients with pancreatic adenocarcinoma, the margin resection status (R) will be assessed and compared: R0 is defined as presence of tumor >1mm from the resection margin, R1 as presence of tumor ≤1mm from the resection margin.
- Number of harvested lymph nodes
- Number of positive lymph nodes (infiltrated by tumor)
- Tumor size, degree of differentiation, perineural and lymphovascular invasion
Measured: During surgery
Differences in locoregional lymphadenectomy in patients with pancreatic adenocarcinoma
In a sub-cohort of patients with pancreatic adenocarcinoma, the number of harvested and positive lymph nodes (infiltrated by tumor) will be assessed and compared between the two groups.
Measured: During surgery
Postoperative recurrence in patients with pancreatic adenocarcinoma
Patients with pancreatic adenocarcinoma who undergo resection in each arm will be followed postoperatively to document disease recurrence, defined as the re-presentation of measurable tumor after resection.
Measured: Postoperative Day 1 up to 5 years after surgery
Postoperative survival in patients with pancreatic adenocarcinoma
Patients with pancreatic adenocarcinoma who undergo resection in each arm will be followed postoperatively to document overall survival, defined as the time between date of operation and date of death.
Measured: Postoperative Day 1 up to 5 years after surgery
Perioperative costs
Comparison of cost between the two groups, defined as the combination of intraoperative and postoperative costs, measured in US Dollars.
Measured: Postoperative Day 1 to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2020
- Study start28 Sep 2020
- Primary completion28 Nov 2024
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Intuitive Surgical
- Responsible party
- Principal investigator, JIABIN JIN, Ruijin Hospital
- Investigators
- Baiyong Shen, PhD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04400357
- Sponsor's protocol ID
- KY2020-93
- Acronym
- PORTAL
- Status last verified
- Dec 2025
- First submitted
- 10 May 2020
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nassour I, Winters SB, Hoehn R, Tohme S, Adam MA, Bartlett DL, Lee KK, Paniccia A, Zureikat AH. Long-term oncologic outcomes of robotic and open pancreatectomy in a national cohort of pancreatic adenocarcinoma. J Surg Oncol. 2020 Aug;122(2):234-242. doi: 10.1002/jso.25958. Epub 2020 Apr 29.
PubMed 32350882Shi Y, Jin J, Qiu W, Weng Y, Wang J, Zhao S, Huo Z, Qin K, Wang Y, Chen H, Deng X, Peng C, Shen B. Short-term Outcomes After Robot-Assisted vs Open Pancreaticoduodenectomy After the Learning Curve. JAMA Surg. 2020 May 1;155(5):389-394. doi: 10.1001/jamasurg.2020.0021.
PubMed 32129815Podda M, Gerardi C, Di Saverio S, Marino MV, Davies RJ, Pellino G, Pisanu A. Robotic-assisted versus open pancreaticoduodenectomy for patients with benign and malignant periampullary disease: a systematic review and meta-analysis of short-term outcomes. Surg Endosc. 2020 Jun;34(6):2390-2409. doi: 10.1007/s00464-020-07460-4. Epub 2020 Feb 18.
PubMed 32072286Zureikat AH, Beane JD, Zenati MS, Al Abbas AI, Boone BA, Moser AJ, Bartlett DL, Hogg ME, Zeh HJ 3rd. 500 Minimally Invasive Robotic Pancreatoduodenectomies: One Decade of Optimizing Performance. Ann Surg. 2021 May 1;273(5):966-972. doi: 10.1097/SLA.0000000000003550.
PubMed 31851003Girgis MD, Zenati MS, King JC, Hamad A, Zureikat AH, Zeh HJ, Hogg ME. Oncologic Outcomes After Robotic Pancreatic Resections Are Not Inferior to Open Surgery. Ann Surg. 2021 Sep 1;274(3):e262-e268. doi: 10.1097/SLA.0000000000003615.
PubMed 31663967Shi Y, Wang W, Qiu W, Zhao S, Wang J, Weng Y, Huo Z, Jin J, Wang Y, Deng X, Shen B, Peng C. Learning Curve From 450 Cases of Robot-Assisted Pancreaticoduocectomy in a High-Volume Pancreatic Center: Optimization of Operative Procedure and a Retrospective Study. Ann Surg. 2021 Dec 1;274(6):e1277-e1283. doi: 10.1097/SLA.0000000000003664.
PubMed 31651533Zhao W, Liu C, Li S, Geng D, Feng Y, Sun M. Safety and efficacy for robot-assisted versus open pancreaticoduodenectomy and distal pancreatectomy: A systematic review and meta-analysis. Surg Oncol. 2018 Sep;27(3):468-478. doi: 10.1016/j.suronc.2018.06.001. Epub 2018 Jun 4.
PubMed 30217304McMillan MT, Zureikat AH, Hogg ME, Kowalsky SJ, Zeh HJ, Sprys MH, Vollmer CM Jr. A Propensity Score-Matched Analysis of Robotic vs Open Pancreatoduodenectomy on Incidence of Pancreatic Fistula. JAMA Surg. 2017 Apr 1;152(4):327-335. doi: 10.1001/jamasurg.2016.4755.
PubMed 28030724Zureikat AH, Postlewait LM, Liu Y, Gillespie TW, Weber SM, Abbott DE, Ahmad SA, Maithel SK, Hogg ME, Zenati M, Cho CS, Salem A, Xia B, Steve J, Nguyen TK, Keshava HB, Chalikonda S, Walsh RM, Talamonti MS, Stocker SJ, Bentrem DJ, Lumpkin S, Kim HJ, Zeh HJ 3rd, Kooby DA. A Multi-institutional Comparison of Perioperative Outcomes of Robotic and Open Pancreaticoduodenectomy. Ann Surg. 2016 Oct;264(4):640-9. doi: 10.1097/SLA.0000000000001869.
PubMed 27433907Jin J, Qin K, Gemenetzis G, Wang Z, Zheng C, Li W, Wu Z, Shi Y, Chen M, Qian J, Weng Y, Chen W, Jin W, Jin R, Li J, Liu L, Chen Y, Han B, Liang X, Sun C, Wu Z, Mou Y, Yin X, Deng X, Peng C, He T, Song Y, Shen B. Robotic versus Open Pancreatoduodenectomy (PORTAL): multicentre, single masked, phase 3, non-inferiority randomised controlled trial. BMJ. 2026 Jul 1;394:e319692. doi: 10.1136/bmj-2026-319692.
PubMed 42386316Jin J, Shi Y, Chen M, Qian J, Qin K, Wang Z, Chen W, Jin W, Lu F, Li Z, Wu Z, Jian L, Han B, Liang X, Sun C, Wu Z, Mou Y, Yin X, Huang H, Chen H, Gemenetzis G, Deng X, Peng C, Shen B. Robotic versus Open Pancreatoduodenectomy for Pancreatic and Periampullary Tumors (PORTAL): a study protocol for a multicenter phase III non-inferiority randomized controlled trial. Trials. 2021 Dec 27;22(1):954. doi: 10.1186/s13063-021-05939-6.
PubMed 34961558