Skip to main content
OpenTrials
Completed

NCT Number: NCT04171440

Observation of Perioperative Outcomes of Robotic Pancreaticoduodenectomy

This is a multi-site prospective, single arm, observational study examining the outcomes of robotic pancreaticoduodenectomy.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Hospital, Baltimore, Maryland, United States

Loading trial locations.

About this study

This is a multi-site prospective, single arm, observational study examining the outcomes of robotic pancreaticoduodenectomy. Adult patients with symptomatic benign, premalignant, or resectable malignant pathologies recommended for resection after multidisciplinary review and have already chosen to have robotic surgery will be evaluated for enrolling into the study.

Relevant operative, postoperative, and pathologic outcomes will be collected prospectively. The well-established enhanced recovery after pancreaticoduodenectomy pathway currently used in our institution will be applied to all patients postoperatively.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥18 years old
  • Symptomatic benign, premalignant, or resectable malignant periampullary and pancreatic tumor 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 robotic 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)

Treatment and study plan

Robotic pancreaticoduodenectomy

Procedure

The robotic pancreaticoduodenectomy is performed through small incisions using robotic-assisted technology. 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 outcomes

  1. Length of hospital stay

    Time frame: up to 90 days post intervention

    Days from date of intervention to discharge

Secondary outcomes

  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 (Yes/no, only the date when the result first changes from No to Yes will be recorded)
    • 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
  2. Number of participants experiencing complications

    Time frame: Day 90 post-intervention

    Number of participants who experience Clavien-Dindo Grade III or higher complications

  3. Operative estimated blood loss

    Time frame: During the surgery

    Blood loss during the surgery (unit: ml)

  4. 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.

  5. 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.

  6. Survival Outcome

    Time frame: Overall survival is from surgery to last time of follow-up or death, assessed up to 60 months-post intervention.

    Recurrence free outcome is from surgery to recurrence.

  7. 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.

  8. 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.

  9. Exploratory outcomes

    Time frame: 30 days after the surgery

    Comprehensive complication index (CCI) is calculated using the multiple complication information within 30 days after the surgery. Each complication included in the index will be recorded as yes or no, and a Clavien-Dindo Grade will be recorded for each complication marked as yes.

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Registry information

Official study title

Perioperative Outcomes of Robotic Approach for Pancreaticoduodenectomy: a Multi-center, Prospective, Single Arm, Observational Study

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Nov 21, 2019
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.