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

April 30, 2022 updated by: JIABIN JIN, Ruijin Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

244

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital Shanghai Jiaotong University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From date of surgery to date of functional recovery as described, assessed up to 90 days.
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
Postoperative Day 1 to Day 56

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative blood loss
Time Frame: During surgery
Comparison of estimated blood loss (in ml)
During surgery
Operative time
Time Frame: During surgery
Comparison of operative time (in minutes, from first incision to skin closure)
During surgery
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)
Postoperative Day 1 to Day 30
Postoperative mortality
Time Frame: Postoperative Day 1 to Day 90
Comparison of mortality rates as a result of the pancreaticoduodenectomy in each arm
Postoperative Day 1 to Day 90
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.
Postoperative Day 1 to Day 90
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
During surgery
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.
During surgery
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.
Postoperative Day 1 up to 5 years after surgery
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.
Postoperative Day 1 up to 5 years after surgery
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.
Postoperative Day 1 to Day 90
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.
Postoperative Day 1 to Day 30
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.
Day of surgery to Postoperative Day 7
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.
Day of surgery to Postoperative Day 7
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.
Day of surgery to Postoperative Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Collaborators

Intuitive Surgical

Investigators

  • Principal Investigator: Baiyong Shen, PhD, Ruijin Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 15, 2020

Primary Completion (ANTICIPATED)

October 7, 2022

Study Completion (ANTICIPATED)

November 30, 2022

Study Registration Dates

First Submitted

May 10, 2020

First Submitted That Met QC Criteria

May 20, 2020

First Posted (ACTUAL)

May 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 3, 2022

Last Update Submitted That Met QC Criteria

April 30, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2020-93

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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