800 Participants Needed

Molecular Detection for Pancreatic Cysts

IT
Overseen ByIN-CYST Team
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 6 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing blood, stool, pancreas cyst fluid, and pancreas juice to find new ways to diagnose dangerous changes in pancreatic cysts. It focuses on patients with high-risk pancreatic cysts. Researchers hope to identify markers in these samples that can help doctors determine if a cyst is likely to become cancerous.

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

The trial protocol does not specify whether you need to stop taking your current medications.

Is the Whipple procedure generally safe for humans?

The Whipple procedure, a complex surgery for pancreatic conditions, has become safer over time, especially in specialized centers. Mortality rates have dropped significantly, and while complications like delayed gastric emptying can occur, improvements in surgical techniques have reduced risks.12345

How is pancreatic surgery different from other treatments for pancreatic cysts?

Pancreatic surgery, such as the Whipple Procedure, is a unique treatment for pancreatic cysts because it involves the physical removal of part or all of the pancreas, which is different from non-surgical methods like molecular analysis that aim to diagnose and manage cysts without surgery. This approach is typically reserved for larger cysts or those suspected to be malignant, whereas molecular analysis can help manage smaller cysts by providing detailed information that might change treatment plans.678910

What data supports the effectiveness of this treatment for pancreatic cysts?

The Whipple procedure, a part of the treatment for pancreatic cysts, has shown improved survival rates for pancreatic cancer, with some centers reporting 5-year survival rates of 20% for adenocarcinoma of the pancreas. Additionally, advancements in surgical techniques have significantly reduced mortality rates, making the procedure safer and more effective.311121314

Who Is on the Research Team?

SM

Shounak Majumder, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for patients with suspected pancreatic cysts who can consent to the study. They must meet specific criteria indicating a higher risk of cancer in their cysts. People are excluded if they've had previous treatments for pancreatic lesions, recent cancer other than skin cancer, past pancreas surgery or necrosis, current pregnancy or nursing, or chemotherapy/radiation within 5 years.

Inclusion Criteria

Patients with pancreatic cystic lesions meeting Fukuoka worrisome or Fukuoka high-risk criteris
Able to provide written informed consent
I might have a cystic tumor in my pancreas.

Exclusion Criteria

I have had chemotherapy or radiation to my abdomen in the past 5 years.
I have had pancreatic cancer or surgery on my pancreas before.
I have had treatment for a pancreatic cyst before.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Immediate Surgery

Participants scheduled for surgical resection after their initial clinical evaluation will be assigned to the 'Immediate Surgery' study group. Blood, stool, pancreatic juice, and cyst fluid collection will be done as per protocol.

Until surgical pathology is known

Clinical Follow-up

Participants not undergoing surgery will be assigned to the 'Clinical Follow-up' study group. Blood, stool, pancreatic juice, and cyst fluid collection will be done as per protocol. Participants will be contacted yearly for a telephone interview until they undergo surgery, die, receive a diagnosis that excludes them from the study, or for 5 years.

5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Blood Collection
  • Endoscopy Exam
  • Pancreatic Cyst Fluid Collection
  • Pancreatic Juice Collection
  • Pancreatic Surgery
  • Stool Collection
Trial Overview The study is testing new diagnostic methods using blood, stool, pancreatic juice and cyst fluid to detect malignant or pre-malignant changes in pancreatic cysts. It involves collecting samples from participants and may include an endoscopy exam and possibly surgery.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: SurgicalExperimental Treatment2 Interventions
Participants scheduled for surgical resection after their initial clinical evaluation will be assigned to the "Immediate Surgery" study group. Blood, stool, pancreatic juice and cyst fluid collection will be done as per protocol. Participants in the Immediate Surgery group will be followed until the surgical pathology of their pancreatic cyst is known.
Group II: Clinical Follow-upExperimental Treatment2 Interventions
Participants not undergoing surgery will be assigned to the "Clinical Follow-up" study group. Blood, stool, pancreatic juice and cyst fluid collection will be done as per protocol. All participants in the Clinical Follow-up group will be contacted yearly for a telephone interview until they undergo surgery, die, receive a diagnosis that excludes them from the study, or for 5 years, and interval medical records will be obtained and reviewed. During follow-up results of clinically indicated follow-up imaging studies will be abstracted

Pancreatic Surgery is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Pancreatic Surgery for:
  • Pancreatic cancer
  • Pancreatic cysts
  • Pancreatitis
  • Ampullary cancer
  • Bile duct cancer
  • Neuroendocrine tumors
  • Small intestine cancer
๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Pancreatic Surgery for:
  • Pancreatic cancer
  • Pancreatic cysts
  • Pancreatitis
  • Ampullary cancer
  • Bile duct cancer
  • Neuroendocrine tumors
  • Small intestine cancer
๐Ÿ‡จ๐Ÿ‡ฆ
Approved in Canada as Pancreatic Surgery for:
  • Pancreatic cancer
  • Pancreatic cysts
  • Pancreatitis
  • Ampullary cancer
  • Bile duct cancer
  • Neuroendocrine tumors
  • Small intestine cancer
๐Ÿ‡ฏ๐Ÿ‡ต
Approved in Japan as Pancreatic Surgery for:
  • Pancreatic cancer
  • Pancreatic cysts
  • Pancreatitis
  • Ampullary cancer
  • Bile duct cancer
  • Neuroendocrine tumors
  • Small intestine cancer
๐Ÿ‡จ๐Ÿ‡ณ
Approved in China as Pancreatic Surgery for:
  • Pancreatic cancer
  • Pancreatic cysts
  • Pancreatitis
  • Ampullary cancer
  • Bile duct cancer
  • Neuroendocrine tumors
  • Small intestine cancer
๐Ÿ‡จ๐Ÿ‡ญ
Approved in Switzerland as Pancreatic Surgery for:
  • Pancreatic cancer
  • Pancreatic cysts
  • Pancreatitis
  • Ampullary cancer
  • Bile duct cancer
  • Neuroendocrine tumors
  • Small intestine cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

Pancreatic resections, including Whipple procedures and total pancreatectomies, have a high postoperative complication rate of 36%, with a mortality rate of 17.9%, highlighting the risks associated with these surgeries.
Whipple resections resulted in significantly lower mortality (14.7%) compared to total pancreatectomies (23.4%), suggesting that Whipple procedures may be safer and equally effective for certain patients with pancreatic cancer.
Surgical experience with pancreatic and periampullary cancer.Herter, FP., Cooperman, AM., Ahlborn, TN., et al.[2019]
The Whipple procedure has significantly improved over the past 20 years, with mortality rates dropping from around 20% to near zero in high-volume centers, thanks to advancements in staging and surgical techniques.
Five-year survival rates for pancreatic adenocarcinoma have reached about 20%, and for other periampullary tumors, long-term survival rates are around 40%, indicating better outcomes and the procedure's expanded use in treating both malignant and benign conditions.
Evolution and current status of the Whipple procedure: an update for gastroenterologists.Strasberg, SM., Drebin, JA., Soper, NJ.[2019]
In a study of 93 patients undergoing Whipple's surgery for pancreatic adenocarcinoma, extensive resection did not lead to higher rates of postoperative complications or mortality compared to classical resection, with complication rates of 16.67% and mortality rates of 2.38% in the extensive group.
The 1- and 2-year survival rates were slightly higher in the extensive group (63.33% and 23.33%) compared to the classical group (58.82% and 20.59%), but the long-term survival benefits of extensive resection remain uncertain and need further research.
[Clinical comparison on the classical versus extensive Whipple's resection for adenocarcinoma of head of pancreas].Liu, XB., Yan, LN., Zhai, HJ., et al.[2005]

Citations

Surgical experience with pancreatic and periampullary cancer. [2019]
Evolution and current status of the Whipple procedure: an update for gastroenterologists. [2019]
[Clinical comparison on the classical versus extensive Whipple's resection for adenocarcinoma of head of pancreas]. [2005]
Guidelines for the surgical management of pancreatic adenocarcinoma. [2007]
Whipple operation revisited. [2004]
[Pancreatoduodenectomy: myth or reality? Personal experience]. [2018]
Complications among Patients Undergoing Pancreaticoduodenectomy in Tertiary Care Centers of Nepal: A Descriptive Cross-sectional Study. [2022]
Long term oncological outcome of laparoscopic techniques in pancreatic cancer. [2020]
Delayed Gastric Emptying as a Complication of Whipple's Procedure: Could it be Much Less Frequent than Anticipated? Could the Definition Be Revised? A Single Center Experience. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Molecular analysis of cyst fluid aspiration in the diagnosis and risk assessment of cystic lesions of the pancreas. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Molecular analysis of pancreatic cyst fluid: a comparative analysis with current practice of diagnosis. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
The role of pancreatic cyst fluid molecular analysis in predicting cyst pathology. [2019]
The role of molecular analysis in the diagnosis and surveillance of pancreatic cystic neoplasms. [2018]
Molecular analysis of pancreatic cyst fluid changes clinical management. [2022]
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