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Robotic Versus Open Pancreaticoduodenectomy for Pancreatic and Periampullary Tumors (PORTAL)

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ClinicalTrials.gov Identifier: NCT04400357
Recruitment Status : Recruiting
First Posted : May 22, 2020
Last Update Posted : May 22, 2020
Sponsor:
Collaborator:
Intuitive Surgical
Information provided by (Responsible Party):
JIABIN JIN, Ruijin Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Pancreatic Adenocarcinoma Pancreatic Cysts Pancreatic Endocrine Tumors Chronic Pancreatitis Cholangiocarcinoma, Extrahepatic Ampullary Adenocarcinoma Duodenal Adenocarcinoma Procedure: Robotic pancreaticoduodenectomy Procedure: Open pancreaticoduodenectomy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 244 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Robotic Versus Open Pancreaticoduodenectomy for Pancreatic and Periampullary Tumors: A Multicenter Phase III Non-Inferiority Randomized Controlled Trial
Estimated Study Start Date : June 15, 2020
Estimated Primary Completion Date : May 7, 2021
Estimated Study Completion Date : November 30, 2022


Arm Intervention/treatment
Experimental: Robotic pancreaticoduodenectomy
Patients randomized in this arm will undergo a robotic pancreaticoduodenectomy.
Procedure: Robotic pancreaticoduodenectomy
Patients in this arm will undergo a pancreaticoduodenectomy with robotic-assisted techonology.

Active Comparator: Open pancreaticoduodenectomy
Patients randomized in this arm will undergo a routine open pancreaticoduodenectomy.
Procedure: Open pancreaticoduodenectomy
Patients in this arm will undergo an open pancreaticoduodenectomy which is the standard surgical approach.




Primary Outcome Measures :
  1. Time to functional recovery postoperatively [ Time Frame: From date of surgery to date of functional recovery as described, assessed up to 90 days. ]

    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.

  2. Percentage of patients with pancreatic adenocarcinoma who achieve administration of adjuvant chemotherapy at 8 weeks postoperatively [ Time Frame: Postoperative Day 1 to Day 56 ]
    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


Secondary Outcome Measures :
  1. Intraoperative blood loss [ Time Frame: During surgery ]
    Comparison of estimated blood loss (in ml)

  2. Operative time [ Time Frame: During surgery ]
    Comparison of operative time (in minutes, from first incision to skin closure)

  3. Postoperative complication rates and associated interventions [ Time Frame: Postoperative Day 1 to Day 30 ]

    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)

  4. Postoperative mortality [ Time Frame: Postoperative Day 1 to Day 90 ]
    Comparison of mortality rates as a result of the pancreaticoduodenectomy in each arm

  5. Quality of life measurements [ Time Frame: Postoperative Day 1 to Day 90 ]

    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.


  6. Margin resection status (R) in patients with pancreatic adenocarcinoma [ Time Frame: During surgery ]

    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

  7. Differences in locoregional lymphadenectomy in patients with pancreatic adenocarcinoma [ Time Frame: During surgery ]
    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.

  8. Postoperative recurrence in patients with pancreatic adenocarcinoma [ Time Frame: Postoperative Day 1 up to 5 years after surgery ]
    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.

  9. Postoperative survival in patients with pancreatic adenocarcinoma [ Time Frame: Postoperative Day 1 up to 5 years after surgery ]
    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.

  10. Perioperative costs [ Time Frame: Postoperative Day 1 to Day 90 ]
    Comparison of cost between the two groups, defined as the combination of intraoperative and postoperative costs, measured in US Dollars.

  11. Effect of operative approach on circulating biomarkers in the postoperative setting [ Time Frame: Postoperative Day 1 to Day 30 ]
    Enrolled patients in the study will be consented for peripheral blood draws in multiple time-points to assess the amount of circulating tumor DNA (ctDNA) and assess potential differences between the two groups in patients with pancreatic adenocarcinoma. The blood draws will occur: 1. immediately pre-operatively, 2. Postoperative days 2, 7, and 30.

  12. Comparison of perioperative inflammatory response (C-reactive protein) [ Time Frame: Day of surgery to Postoperative Day 7 ]
    Patients C-reactive protein (CRP, measured in ng/L) will be assessed with peripheral blood draws on the day of operation, and postoperative days 1, 3, and 7.

  13. Comparison of perioperative inflammatory response (Neutrophil-to-Lymphocyte ratio) [ Time Frame: Day of surgery to Postoperative Day 7 ]
    Patients neutrophil-to-lymphocyte ratio (NLR, defined as the division of absolute neutrophil number to absolute lymphocyte number) will be assessed with peripheral blood draws on the day of operation, and postoperative days 1, 3, and 7.

  14. Comparison of perioperative inflammatory response (Interleukin-6) [ Time Frame: Day of surgery to Postoperative Day 7 ]
    Patients Interleukin 6 (IL-6, measured in pg/mL) will be assessed with peripheral blood draws on the day of operation, and postoperative days 1, 3, and 7.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04400357


Contacts
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Contact: Jiabin JIN, PhD 008618101870031 jjb11501@rjh.com.cn
Contact: Georgios Gemenetzis, MD georgios.gemenetzis@glasgow.ac.uk

Locations
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China, Shanghai
Ruijin Hospital Shanghai Jiaotong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200025
Contact: jiabin JIN, PhD    008602164370045 ext 670904    jjb11501@rjh.com.cn   
Sponsors and Collaborators
Ruijin Hospital
Intuitive Surgical
Investigators
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Principal Investigator: Baiyong Shen, PhD Ruijin Hospital
Publications:

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Responsible Party: JIABIN JIN, Attending Surgeon, Pancreatic Disease Center, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT04400357    
Other Study ID Numbers: KY2020-93
First Posted: May 22, 2020    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by JIABIN JIN, Ruijin Hospital:
pancreatic cancer
circulating tumor DNA
pancreaticoduodenectomy
Whipple
robotic
daVinci
outcomes
pancreatectomy
functional recovery
complications
recurrence
perioperative inflammation
Additional relevant MeSH terms:
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Cholangiocarcinoma
Endocrine Gland Neoplasms
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Adenocarcinoma
Pancreatic Cyst
Pancreatitis
Pancreatitis, Chronic
Carcinoma
Pancreatic Diseases
Digestive System Diseases
Cysts
Endocrine System Diseases