Robotic Surgery for Gallbladder Conditions

Overseen By Daniel Robledo, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: AdventHealth

Disqualifiers: Pregnancy, BMI > 26, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

35 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of the da Vinci SP® Single-Port Robotic Surgical System for surgeries involving the gallbladder, stomach, pancreas, esophagus, and liver. The researchers aim to evaluate how well this robotic system performs in specific operations, such as removing the gallbladder or parts of the stomach. Individuals diagnosed with conditions like GERD (a type of acid reflux), hiatal hernia, or certain benign or early-stage malignant diseases of the stomach, pancreas, or liver may be suitable candidates. Participants will undergo surgery using this advanced robotic system, with the hope of improving surgical outcomes. As an unphased trial, this study offers participants the chance to contribute to innovative surgical advancements and potentially benefit from cutting-edge technology.

Do I need to stop my current medications for the trial?

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 the da Vinci SP Surgical System is safe for HPB and Foregut operations?

Research shows that the da Vinci SP Single-Port Robotic Surgical System is generally well-received in surgeries. Studies have found that this system allows for minimally invasive surgery, enabling surgeons to make smaller cuts than with traditional methods. This can lead to fewer complications and faster recovery times for patients.

The da Vinci SP system avoids external collisions during surgery, providing surgeons with better access to the area they need to operate on. It has been used in various surgeries, demonstrating its adaptability and safety for different procedures.

While all surgeries carry some risk, robotic systems like the da Vinci SP aim to lower those risks. Most patients have experienced fewer negative events with this system compared to more invasive surgeries. However, discussing any concerns with a doctor is important to understand how this system might work for individual needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the da Vinci SP® Single-Port Robotic Surgical System because it offers a less invasive approach to surgeries like gallbladder removal and others included in this study. Unlike traditional open surgeries or even multi-port laparoscopic procedures, this robotic system uses a single incision, which can lead to less scarring, reduced pain, and quicker recovery times for patients. Additionally, the precision of the robotic system allows for more delicate and accurate operations, potentially improving overall surgical outcomes.

What evidence suggests that the da Vinci SP Surgical System is effective for gallbladder conditions?

Studies have shown that the da Vinci SP Single-Port Robotic Surgical System, used by participants in this trial, is safe and effective for various surgeries. Research indicates that this system enables surgeons to operate through a single small incision, potentially leading to quicker recovery times. One study involving over 300 patients who had their gallbladders removed using this method reported positive surgical outcomes. Initial findings suggest that the system is flexible and suitable for complex surgeries, such as those on the pancreas and liver. Overall, the da Vinci SP system appears to be a high-performance option with good short-term results for patients undergoing these surgeries. ^{1 2 6 7 8}

Who Is on the Research Team?

Sharona Ross, MD

Principal Investigator

AdventHealth

Are You a Good Fit for This Trial?

This trial is for individuals needing surgery for certain conditions of the liver, pancreas, gallbladder, stomach, and esophagus. It's not clear what specific criteria must be met or who can't participate without more detailed inclusion and exclusion information.

Inclusion Criteria

I am 18-80 years old, with a BMI ≤ 26, ASA ≤ 3, and have a pancreatic condition without spread or vascular involvement.

I am 18-80 years old, with a BMI of 26 or less, and have a benign condition needing gallbladder surgery.

I am 18-80 years old, with GERD or hiatal hernia, a BMI ≤ 26, and in good health.

Exclusion Criteria

I do not require emergency surgery, am not pregnant or nursing, have a BMI ≤ 26, have not had previous abdominal surgery, can consent, and am cleared for general anesthesia and minimally invasive surgery.

I am not pregnant, have a BMI ≤ 26, and can consent. I haven't had previous abdominal surgery and am fit for surgery.

I need an urgent gallbladder removal but I'm not pregnant, nursing, overweight, or have had previous abdominal surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Operative

Assessment of patient fitness using ASA Physical Status Score and Charlson Comorbidity Index Score

1 week

1 visit (in-person)

Surgery

Participants undergo the planned da Vinci SP-assisted operation

Intraoperative

1 visit (in-person)

Post-Operative

Monitoring of intraoperative and post-operative adverse events and complications

10 days

In-hospital stay

Follow-up

Participants are monitored for safety and effectiveness after surgery, including 30-day complications and readmission

2 months

2 visits (in-person)

Long-term Follow-up

Assessment of survival, disease recurrence, and long-term adverse events

Annually through year 5

What Are the Treatments Tested in This Trial?

Interventions

• da Vinci SP® Single-Port Robotic Surgical System

Trial Overview The study is testing the da Vinci SP Surgical System in various surgeries like gallbladder removal and stomach surgery to see how safe it is and how well it works.

How Is the Trial Designed?

Group I: da Vinci SP® Single-Port Robotic Surgical System Experimental Treatment 1 Intervention

This study will be separated into four stages, depending on the condition the participant is diagnosed with. Each Participant will go through (1) one operation. Stage One will include five (5) subjects who undergo cholecystectomy and five (5) subjects who undergo hiatal hernia repair with fundoplication (Nissen or Toupet) for a total of ten (10) subjects. Stage Two will include five (5) subjects who undergo gastrectomy and five (5) subjects who undergo distal pancreatectomy for a total of ten (10) subjects. Stage Three will include five (5) subjects who undergo pancreaticoduodenectomy and five (5) subjects who undergo esophagectomy for a total of ten (10) subjects. Stage Four will include five (5) subjects who undergo hepatectomy

da Vinci SP® Single-Port Robotic Surgical System is already approved in United States for the following indications:

Approved in United States as da Vinci SP Surgical System for:

• Urological procedures (including prostate and kidney surgery)
• Lateral oropharyngectomy procedures (radical tonsillectomy)
• Tongue base resection
• Simple prostatectomy
• Radical prostatectomy

Who Is Running the Clinical Trial?

AdventHealth

Lead Sponsor

Trials

118

Recruited

31,800+

Published Research Related to This Trial

In a study involving 10 patients with gallbladder disease, robotic single-port cholecystectomy using the da Vinci system was successfully completed in 9 out of 10 cases, demonstrating its feasibility.

The average operating time for robotic surgery (105.3 minutes) was comparable to traditional multiport laparoscopic cholecystectomy (106.1 minutes), and there were no serious complications reported, indicating a safe alternative for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-port robotic cholecystectomy: results from a first human use clinical study of the new da Vinci single-site surgical platform. Wren, SM., Curet, MJ.[2011]

The da Vinci SP® surgical system was evaluated in a study involving 50 patients undergoing various colorectal procedures, demonstrating significant reductions in operative time as experience with the system increased, indicating improved efficiency.

The study found that the dVSP system is safe for colorectal surgery, with only six mild adverse events reported and no local recurrences, suggesting it is a promising option for oncological procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-incision robotic colorectal surgery with the da Vinci SP® surgical system: initial results of 50 cases. Kim, HS., Oh, BY., Cheong, C., et al.[2023]

The first robotic single-site cholecystectomy using the da Vinci SP system was successfully performed on a 59-year-old female patient, demonstrating the system's safety and technical feasibility with no significant intraoperative events.

The operation took 89 minutes with a quick docking time of 6 minutes, highlighting the efficiency of the da Vinci SP system, although the lack of an assistant port may limit its use in more complex surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical feasibility of da Vinci SP single-port robotic cholecystectomy: a case report. Cruz, CJ., Yang, HY., Kang, I., et al.[2020]

In a study involving 31 women with benign gynecologic diseases, robotic single-port surgery using the da Vinci® SP system was performed successfully with no major complications or need for conversion to traditional laparoscopic methods.

The procedure demonstrated favorable operative outcomes, including a mean operating time of 126.3 minutes and a hospitalization duration of 4.6 days, suggesting it could be a safe and effective alternative for treating various benign gynecologic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic single-port surgery using the da Vinci SP® surgical system for benign gynecologic disease: A preliminary report. Shin, HJ., Yoo, HK., Lee, JH., et al.[2020]

The da Vinci SP robotic surgical system demonstrated improved perioperative outcomes in robotic single-site cholecystectomy, with significantly shorter operation, docking, and dissection times compared to the Si-robotic system, indicating enhanced efficiency.

Patients undergoing robotic single-site cholecystectomy with the da Vinci SP system experienced less immediate postoperative pain and shorter hospital stays, suggesting that this method is not only safe but also effective for gallbladder surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial experiences of robotic SP cholecystectomy: a comparative analysis with robotic Si single-site cholecystectomy. Cruz, CJ., Huynh, F., Kang, I., et al.[2023]

The da Vinci single port robotic platform for cholecystectomy in adolescents demonstrated safety and efficacy, with no fatalities or returns to the operating room among the 7 patients studied, and a low mean estimated blood loss of only 2 mL.

The use of wristed instruments allowed for improved surgeon dexterity, and the single umbilical incision provided excellent cosmetic results, making this approach promising for pediatric robotic surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the da Vinci Single Port Robotic Platform on Cholecystectomy in Adolescents. Klazura, G., Graf, A., Sims, T., et al.[2022]

The da Vinci SP system allows for successful single-port robotic urologic surgeries in 120 patients, demonstrating its efficacy without the need to convert to other surgical approaches.

The surgeries were performed safely, with only two cases experiencing Clavien-Dindo grade III complications, indicating a low rate of serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technique and perioperative outcomes of single-port robotic surgery using the da Vinci SP platform in urology. Kim, KH., Ahn, HK., Kim, M., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11362253/

Da Vinci single-port robotic system current application and ... The reported surgical and short-term outcomes are promising; a wide range of procedures have been performed safely. Some groups have found ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1743919122005593

Single-port (SP) robotic pancreatic surgery using the da ... In this study, we retrospectively analyzed the perioperative outcomes of SPRPS at a single center. 2. Patients and methods. The clinical data of 23 consecutive ...

3. intuitive.com intuitive.com/en-us/products-and-services/da-vinci/sp

Single Port | Da Vinci SP Da Vinci SP is a versatile and high-performance single port robotic surgical system that empowers surgeons to approach their surgical procedures differently.

4. nature.com nature.com/articles/s41598-023-36055-x

A single-center experience of over 300 cases ... This retrospective single-center study enrolled patients who underwent single-incision robotic cholecystectomy between July 2014 and July 2021.

5. link.springer.com link.springer.com/content/pdf/10.1007/s00464-024-11126-w.pdf

Da Vinci single-port robotic system current application and ... The reported surgical and short-term outcomes are promising; a wide range of procedures have been performed safely. Some groups have found ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06562179

A Prospective, Single-Center Investigation of the da Vinci ... The purpose of this study is to collect data to evaluate safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in ...

7. adventhealth.com adventhealth.com/news/innovative-use-da-vinci-sp-robot-hpb-surgeries-set-revolutionize-patient-care-0

Innovative use of Da Vinci SP robot for HPB surgeries set ... The system's single-arm design eliminates the risk of external collisions, providing surgeons with 360° anatomical access without the need for ...

8. ouhealth.com ouhealth.com/health-services/surgery-services/minimally-invasive-robotic-assisted-surgery/

Minimally Invasive & Robotic-Assisted Surgery at OU Health All minimally invasive procedures share the common approach of using much smaller incisions than typically required by traditional open surgery.