Robotic Surgery for Pancreatic Cancer

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the outcomes of using robotic surgery to treat pancreatic cancer. It focuses on a specific procedure, pancreaticoduodenectomy, which removes part of the pancreas and nearby tissues. Eligible patients have a removable pancreatic tumor and are prepared for this surgery. The trial aims to assess how robotic assistance enhances the procedure compared to traditional methods. Participants may find the surgery less invasive, potentially leading to a quicker recovery. As an unphased trial, it offers patients the chance to contribute to advancing surgical techniques and possibly experience a faster recovery.

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.

What prior data suggests that robotic pancreaticoduodenectomy is safe?

Research has shown that robotic pancreaticoduodenectomy, a surgery using robotic tools, is generally safe for patients. A review of studies found that this method can lead to better results in examining tissue, although it might take longer to perform. Studies also indicate that robotic-assisted surgery often results in better short-term outcomes compared to traditional methods, meaning patients might recover faster or experience fewer complications immediately after surgery. However, all surgeries carry some risk. The robotic approach remains a safe and practical option for those needing this type of procedure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about robotic pancreaticoduodenectomy because it offers a minimally invasive approach to treating pancreatic cancer, using cutting-edge robotic-assisted technology. Unlike traditional open surgery, which involves large incisions, this technique uses small incisions, potentially reducing recovery time and minimizing complications. The precision of robotic assistance may also enhance surgical outcomes by allowing for more accurate removal of cancerous tissue. This combination of less invasiveness and heightened precision is why there's so much interest in this treatment option.

What evidence suggests that robotic pancreaticoduodenectomy is effective for pancreatic cancer?

This trial will compare different surgical approaches for pancreatic cancer, including robotic pancreaticoduodenectomy (PD). Studies have shown that robotic PD holds promise for pancreatic cancer surgery. Research indicates that these procedures lead to fewer major complications, occurring in less than 24% of cases. Specifically, the risk of a significant issue like a pancreatic fistula, a problematic leak, is low, occurring in just 7.8% of patients. The chances of death within 30 and 90 days after surgery are also low, at 1.4%. Robotic PD is associated with slightly better overall survival compared to traditional open surgery. Additionally, it removes cancer tissue more cleanly, although it takes a bit longer to perform. ^{1 4 6 7 8}

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12287213/

Long-term oncologic outcomes of robot-assisted ... Robot-assisted pancreaticoduodenectomy (RPD) has been gaining attention for its potential benefits in short-term surgical outcomes compared with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7871451/

500 Minimally Invasive Robotic Pancreatoduodenectomies Major complications (Clavien >2) occurred in less than 24%, clinically relevant postoperative pancreatic fistula in 7.8%, 30- and 90-day mortality were 1.4% and ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1091255X2400581X

Open vs robotic-assisted pancreaticoduodenectomy, cost- ... Robotic PDs was associated with a slightly better overall survival (95% CI, 1.020–1.233) and higher costs (95% CI, 0.134–1.139; P = .013). Mean length of stay ( ...

4. nature.com nature.com/articles/s41598-021-83391-x

Robotic pancreaticoduodenectomy provides better ... This meta-analysis found that robotic PD provides better histopathological outcomes as compared to open PD at the cost of longer operating time.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06981273

Robotic vs Open Pancreatoduodenectomy (SPAIN PD) This is a national, multicenter study in Spain comparing the outcomes of robotic versus open pancreatoduodenectomy (PD). The main goal is to assess ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7511570/

Current statement and safe implementation of minimally ... Minimally invasive distal pancreatectomy for pancreatic ductal adenocarcinoma appears to be a feasible, safe, and oncologically equivalent technique in ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1015958423016883

Survival and surgical outcomes of robotic versus open ... Pancreaticoduodenectomy provides a 5-year overall survival of 38%–68 %, which is better than that of pancreatic head or distal common bile duct cancers.

8. wjgnet.com wjgnet.com/1948-9366/full/v15/i1/60.htm

An analysis of the National Cancer Database Despite all advancements, the prognosis remains, poor with an overall 5-year survival of only 10.8%. Recently, a robotic platform has become an ...