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Comparison of Perioperative Outcomes Between Minimally Invasive and Open Pancreaticoduodenectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04171440
Recruitment Status : Not yet recruiting
First Posted : November 21, 2019
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary:
The phase 3 randomized trial is to compare perioperative outcomes between minimally invasive and open approach for pancreaticoduodenectomy

Condition or disease Intervention/treatment Phase
Pancreaticoduodenectomy Procedure: minimally invasive pancreaticoduodenectomy Procedure: open pancreaticoduodenectomy Not Applicable

Detailed Description:

This is a single-blinded randomized trial aiming to examine the outcomes associated with minimally invasive pancreaticoduodenectomy (MIPD), including robotic or laparoscopic, versus open pancreaticoduodenectomy. Adult patients with symptomatic benign, premalignant, or resectable malignant pathologies recommended for resection after a multidisciplinary review will be evaluated for inclusion into the study.

Patients recruited will be randomized in a 1:1 ratio to either MIPD or open pancreaticoduodenectomy. A specialized abdominal dressing (40x40cm) will be applied to blind the patient from the intervention. The primary outcome(time to functional recovery) and secondary outcomes(including rates of post-surgery complications and sequential quality of life) will be recorded in detail and analyzed.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of Perioperative Outcomes Between Minimally Invasive and Open Approach for Pancreaticoduodenectomy: a Single-center, Patient-blinded, Randomized Controlled Trial
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

Arm Intervention/treatment
Experimental: Cohort A-minimally invasive pancreaticoduodenectomy
Patients randomized to Cohort A will undergo pancreaticoduodenectomy through small incisions with state-of-the-art robotic-assisted technology or endoscopic techniques.
Procedure: minimally invasive pancreaticoduodenectomy
The minimally invasive pancreaticoduodenectomy is performed through small incisions using robotic-assisted technology or endoscopic techniques. Pancreaticoduodenectomy is the operation that is necessary to remove tumors of the head and neck of the pancreas, lower portion of the bile duct, and the ampulla of Vater.

Active Comparator: Cohort B-open pancreaticoduodenectomy
Patients randomized to this arm will undergo open pancreaticoduodenectomy.
Procedure: open pancreaticoduodenectomy
Open pancreaticoduodenectomy is considered the current standard of care. Pancreaticoduodenectomy is the operation that is necessary to remove tumors of the head and neck of the pancreas, lower portion of the bile duct, and the ampulla of Vater




Primary Outcome Measures :
  1. Time to functional recovery [ Time Frame: Day 1 post-intervention to functional recovery ]

    Days to functional recovery, which requires that all the following are met:

    • Pain controlled on oral analgesics only
    • Able to maintain ≥50% of required caloric intake
    • No need for intravenous fluids for hydration
    • Return to independent mobility or baseline mobility for those with previous mobility deficits


Secondary Outcome Measures :
  1. Number of participants experiencing complications [ Time Frame: Day 90 post-intervention ]
    Number of participants who experience Clavien-Dindo Grade III or higher complications

  2. Length of hospital stay [ Time Frame: up to 90 days post intervention ]
    Days from date of intervention to discharge

  3. Number of participants experiencing pancreaticoduodenectomy-specific complications [ Time Frame: Day 90 post-intervention ]
    Number of participants who experience complications including pancreatic fistula, delayed gastric emptying, postoperative bleeding, wound infection, bile leak, chyle leak, other gastrointestinal leakage, re-intervention (radiographic,surgical, endoscopic), 30-day mortality, 90-day mortality.

  4. Pathological outcomes as assessed by Pathological response to neoadjuvant therapy [ Time Frame: Day 90-post intervention ]
    Pathological response to neoadjuvant therapy(if there is any) reported by pathologist reviewing the resected surgical specimen. Pathological outcomes as defined by Protocol for Examination of Specimens from Patients with Carcinoma of the Pancreas (Pancreas Exocrine 4.0.0.1), where: complete response (score 0) is no viable cancer cells; marked response/minimal residual cancer (score 1) is presence of single cells or rare small groups of cancer cells; moderate response (score 2) is residual cancer with evident tumor regression, but more than single cells or rare groups of cancer cells; poor or no response (score 3) is extensive residual cancer with no evident tumor regression.

  5. Quality of life (QoL) as measured by EQ-5D-3L [ Time Frame: EQ-5D-3L will be measured at 2 to 4 weeks and 3 to 6 months-post intervention. ]

    The EQ-5D-3L questionnaire essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).

    The EQ-5D-3L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems.This decision results into a 1-digit number that expresses the level selected for that dimension. Numbers range from 1-3, with a higher number reflected more problems.

    The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state', ranging from 0 to 100. A higher score reflects a worse health state.


  6. Quality of life (QoL) as measured by QLQ-C30 (version 3) [ Time Frame: QLQ-C30 will be measured at 2 to 4 weeks and 3 to 6 months-post intervention. ]
    QLQ-C30 questionnaire includes five functional scales, three symptom scales, a global health status / QoL scale, and six single items. All of the scales and single-item measures range in score from 0 to 100. A higher score represents a higher response level.

  7. Operative estimated blood loss [ Time Frame: During the surgery ]
    Blood loss during the surgery (unit: ml)



Information from the National Library of Medicine

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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:

  • ≥18 years old
  • Symptomatic benign, premalignant, or resectable malignant pancreatic pathology requiring resection
  • Fit to undergo elective pancreaticoduodenectomy after evaluation by the surgical and anesthesiology teams
  • Able to consent to participate in the study
  • Appropriate for minimally invasive approach as determined by participating surgeons

Exclusion Criteria:

  • Arterial (superior mesenteric artery, celiac axis, hepatic artery) or venous involvement (superior mesenteric vein, portal vein) which meets the definition of borderline or unresectable tumor
  • Pregnancy
  • BMI >40 kg/m2
  • Patient requires an additional surgical resection during the index operation (such as hepatectomy or colectomy)

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): NCT04171440


Contacts
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Contact: Jin He, MD,PhD +1(410)614-7551 jhe11@jhmi.edu

Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Investigators
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Principal Investigator: Jin He, MD,PhD Johns Hopkins University

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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT04171440    
Other Study ID Numbers: J19102
IRB00219628 ( Other Identifier: Johns Hopkins Medicine IRB )
First Posted: November 21, 2019    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 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
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
minimal invasive, robotic, laparoscopic,open