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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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
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
  • 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

Other trials in China

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.

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 groups in NCT04400357
Study groupRoleWhat they receive
Robotic pancreaticoduodenectomyExperimentalPatients randomized in this arm will undergo a robotic pancreaticoduodenectomy.
Receives: Procedure: Robotic pancreaticoduodenectomy
Open pancreaticoduodenectomyActive comparatorPatients 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.

  1. 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)

  1. Intraoperative blood loss

    Comparison of estimated blood loss (in ml)

    Measured: During surgery

  2. Operative time

    Comparison of operative time (in minutes, from first incision to skin closure)

    Measured: During surgery

  3. 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

  4. 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

  5. Postoperative mortality

    Comparison of mortality rates as a result of the pancreaticoduodenectomy in each arm

    Measured: Postoperative Day 1 to Day 90

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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.

  1. First posted22 May 2020
  2. Study start28 Sep 2020
  3. Primary completion28 Nov 2024
  4. Study completion28 Feb 2025

Resources

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)
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 32350882

  • Shi 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 32129815

  • Podda 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 32072286

  • Zureikat 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 31851003

  • Girgis 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 31663967

  • Shi 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 31651533

  • Zhao 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 30217304

  • McMillan 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 28030724

  • Zureikat 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 27433907

  • Jin 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 42386316

  • Jin 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

Questions about this trial

What is this clinical trial studying?

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.

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 3 inclusion and 6 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 18 Dec 2025. 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 China. 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?

Time to functional recovery postoperatively (time frame: From date of surgery to date of functional recovery as described, assessed up to 90 days.). 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 NCT04400357, which also lists 11 linked publications.

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 18 Dec 2025.

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