Robotic Surgery for Pancreatic Cancer

Recruiting at 1 trial location

Overseen By Jin He, MD,PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Disqualifiers: Pregnancy, BMI >40, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

81 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is robotic surgery for pancreatic cancer safe?

Research suggests that robotic pancreatic surgery is generally safe and feasible, with some studies showing fewer complications compared to traditional open surgery. However, there are limited reports specifically evaluating its safety after chemotherapy. ^{1 2 3 4 5}

How does robotic pancreaticoduodenectomy differ from other treatments for pancreatic cancer?

Robotic pancreaticoduodenectomy is a minimally invasive surgery that uses robotic technology to perform complex procedures with precision, potentially offering cosmetic benefits and safety similar to open surgery. However, it does not currently show oncologic advantages over traditional methods and is mainly justified for benign or low-grade malignant tumors. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment minimally invasive pancreaticoduodenectomy for pancreatic cancer?

Research suggests that minimally invasive pancreaticoduodenectomy, including robotic surgery, may offer benefits like improved recovery time and shorter hospital stays compared to traditional open surgery. However, the overall effectiveness and safety, especially for pancreatic cancer, are still being evaluated and remain somewhat controversial. ^{11 12 13 14 15}

Who Is on the Research Team?

Jin He, MD,PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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

Able to consent to participate in the study

Exclusion Criteria

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

BMI >40 kg/m2

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo robotic pancreaticoduodenectomy

During the surgery

1 visit (in-person)

Postoperative Recovery

Participants follow an enhanced recovery pathway after surgery

Up to 90 days

Multiple visits (in-person)

Follow-up

Participants are monitored for complications and quality of life

Up to 60 months

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• minimally invasive pancreaticoduodenectomy
• open pancreaticoduodenectomy
• robotic pancreaticoduodenectomy

Trial Overview 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.

How Is the Trial Designed?

Group I: Minimally Invasive Pancreaticoduodenectomy Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Survival and Robotic Approach for Pancreaticoduodenectomy: A Propensity Score-Match Study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Outcomes after robot-assisted pancreaticoduodenectomy for periampullary lesions. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Minimally invasive surgical approach compared with open pancreaticoduodenectomy: a systematic review and meta-analysis on the feasibility and safety. [2018]

4. Germany pubmed.ncbi.nlm.nih.gov

Perioperative and oncological outcomes following minimally invasive versus open pancreaticoduodenectomy for pancreatic duct adenocarcinoma. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Comparing Minimally Invasive and Open Pancreaticoduodenectomy for the Treatment of Pancreatic Cancer: a Win Ratio Analysis. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Safety and oncologic efficacy of robotic compared to open pancreaticoduodenectomy after neoadjuvant chemotherapy for pancreatic cancer. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Risk factors for complications in patients undergoing pancreaticoduodenectomy: A NSQIP analysis with propensity score matching. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Robotic Versus Laparoscopic Pancreaticoduodenectomy: a NSQIP Analysis. [2018]

9. Germany pubmed.ncbi.nlm.nih.gov

Unplanned conversions of robotic pancreaticoduodenectomy: short-term outcomes and suggested stepwise approach for a safe conversion. [2023]

10. Canada pubmed.ncbi.nlm.nih.gov

Early experience with robotic pancreatic surgery in a Canadian institution. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

The state of the art of robotic pancreatectomy. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Comparison Between Minimally Invasive and Open Pancreaticoduodenectomy: A Systematic Review. [2018]

13. United States pubmed.ncbi.nlm.nih.gov

Robotic versus open pancreaticoduodenectomy: a comparative study at a single institution. [2022]

14. France pubmed.ncbi.nlm.nih.gov

Surgical and oncological outcomes of our first 59 cases of robotic pancreaticoduodenectomy. [2020]

15. Denmark pubmed.ncbi.nlm.nih.gov

[Minimally invasive surgery for malignant diseases in pancreas]. [2021]