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Procedure

Robotic Surgery for Pancreatic Cancer

N/A

Recruiting

Led By Jin He, MD,PhD

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Fit to undergo elective pancreaticoduodenectomy after evaluation by the surgical and anesthesiology teams

Symptomatic benign, premalignant, or resectable malignant periampullary and pancreatic tumor requiring resection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up eq-5d-3l will be measured at 2 to 4 weeks and 3 to 6 months-post intervention.

Awards & highlights

Study Summary

This trial will study the outcomes of people who have had a robotic pancreaticoduodenectomy, which is a surgery to remove the pancreas and part of the small intestine.

Who is the study for?

This trial is for adults over 18 with symptomatic benign, premalignant, or resectable malignant tumors near the pancreas who are fit for surgery. Candidates must be able to consent and suitable for a robotic surgical approach. It's not for individuals with a BMI over 40, those needing additional major surgeries at the same time, or if their tumor involves major blood vessels or they're pregnant.Check my eligibility

What is being tested?

The study observes outcomes of patients undergoing robotic pancreaticoduodenectomy—a minimally invasive surgery performed by robots on the pancreas and surrounding areas. It's a single-arm observational study across multiple sites without comparing different treatments.See study design

What are the potential side effects?

Since this is an observational study focusing on surgical outcomes rather than medication side effects, specific side effects aren't listed. However, general risks may include bleeding, infection, pain at the incision site, and complications related to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am considered fit for major pancreatic surgery by my surgical and anesthesia teams.

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I have a tumor near the bile duct or pancreas that needs surgical removal.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ qlq-c30 will be measured at 2 to 4 weeks and 3 to 6 months-post intervention.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~qlq-c30 will be measured at 2 to 4 weeks and 3 to 6 months-post intervention.

This trial's timeline: 3 weeks for screening, Varies for treatment, and qlq-c30 will be measured at 2 to 4 weeks and 3 to 6 months-post intervention. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Length of hospital stay

Secondary outcome measures

Exploratory outcomes

Number of participants experiencing complications

Number of participants experiencing pancreaticoduodenectomy-specific complications

+6 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Minimally Invasive PancreaticoduodenectomyExperimental Treatment1 Intervention

Patients that undergo pancreaticoduodenectomy through small incisions with state-of-the-art robotic-assisted technology.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor

558 Previous Clinical Trials

32,839 Total Patients Enrolled

Jin He, MD,PhDPrincipal InvestigatorJohns Hopkins University

Media Library

minimally invasive pancreaticoduodenectomy (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04171440 — N/A

Pancreaticoduodenectomy Research Study Groups: Minimally Invasive Pancreaticoduodenectomy

Pancreaticoduodenectomy Clinical Trial 2023: minimally invasive pancreaticoduodenectomy Highlights & Side Effects. Trial Name: NCT04171440 — N/A

minimally invasive pancreaticoduodenectomy (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04171440 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant size of this research project?

"Affirmative. According to the clinicaltrials.gov database, this experiment is currently enrolling patients and was initially posted on February 18th 2020. Approximately 81 individuals need to be recruited from two distinct sites in order for it to reach completion."

Answered by AI

Are any additional participants being welcomed into this research effort?

"Affirmative. Records on clinicaltrials.gov establish that this medical trial has been recruiting since February 18th 2020 and updated as recently as April 22nd 2022. A total of 81 patients are required from two different healthcare institutions."

Answered by AI

Recent research and studies

Annals of SurgeryJournal

The Comprehensive Complication Index

Slankamenac, Ksenija, Rolf Graf, Jeffrey Barkun, Milo A. Puhan, and Pierre-Alain Clavien. 2013. “The Comprehensive Complication Index”. Annals of Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/sla.0b013e318296c732.

clinicaltrials.govStudy

Observation of Perioperative Outcomes of Robotic Pancreaticoduodenectomy

2020. "Observation of Perioperative Outcomes of Robotic Pancreaticoduodenectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04171440.