What side effects are associated with this type of intervention?

Common side effects of pancreaticoduodenectomy, including robotic-assisted procedures, are delayed gastric emptying, pancreatic fistula, infections, bleeding, and nutritional deficiencies. Robotic assistance aims to reduce complications through greater precision and minimally invasive techniques, potentially leading to reduced blood loss and shorter recovery times, though it still shares many of the same risks as traditional methods.

What prior FDA approvals exist?

The FDA has approved various treatments for pancreatic cancer, including chemotherapeutic agents like gemcitabine and FOLFIRINOX, which are often used in conjunction with surgical procedures like pancreaticoduodenectomy. While specific FDA approvals for robotic-assisted pancreaticoduodenectomy are not detailed, the use of robotic systems in surgery has been increasingly adopted to enhance precision and recovery outcomes. Robotic assistance in pancreaticoduodenectomy aims to improve surgical accuracy and reduce recovery times, aligning with the broader trend of minimally invasive surgical techniques.

What other types of research exist?

Promising, novel alternatives to Robotic Pancreaticoduodenectomy for patients in 2024 include: 1) Laparoscopic Pancreaticoduodenectomy, which offers a minimally invasive approach with potential benefits in recovery time and reduced complications. 2) Hybrid Minimally Invasive Pancreaticoduodenectomy, combining laparoscopic and open techniques to optimize outcomes. 3) Enhanced Recovery After Surgery (ERAS) protocols, which are being increasingly integrated with surgical techniques to improve patient outcomes and recovery times.

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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

Must not have

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

Patient requires an additional surgical resection during the index operation (such as hepatectomy or colectomy)

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

No Placebo-Only Group

Summary

This trial studies the outcomes of using a robot to help perform pancreatic surgery on adults with certain pancreatic conditions. The robot makes the surgery more precise and less invasive, which may lead to quicker recovery. Robotic surgery has been introduced in the field of minimally invasive surgery to improve the handling of high-demanding procedures with encouraging results.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My tumor cannot be surgically removed due to its location near major blood vessels.

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I need more surgery like liver or colon removal during my main operation.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Length of hospital stay

Secondary study objectives

Exploratory outcomes

Number of participants experiencing complications

Number of participants experiencing pancreaticoduodenectomy-specific complications

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Pancreaticoduodenectomy, commonly known as the Whipple procedure, involves the removal of the head of the pancreas, part of the small intestine, the gallbladder, and the bile duct to treat pancreatic cancer and other related conditions. Robotic assistance in performing this surgery enhances the precision of the procedure through improved visualization and dexterity, which can lead to fewer complications, reduced blood loss, and shorter recovery times. These benefits are crucial for patients as they can significantly improve surgical outcomes and overall survival rates, making the treatment more effective and less burdensome.

Robotic pancreatoduodenectomy with vascular resection: Outcomes and learning curve.