IPMN, PancreaticNCT05593393
A Long-term Follow-up Cohort Study in Patients With Intraductal Papillary Mucinous Neoplasm
An observational study of IPMN, Pancreatic, run by Peking Union Medical College Hospital.
Trial summary
Study objective: To establish a long-term follow-up cohort of patients with IPMN, study the follow-up, clinical outcomes and prognostic factors of patients with IPMN, and provide a basis for clinical decisions and guidelines. Study design: This is a real world, multicenter, prospective, observational cohort study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IPMN, Pancreatic
- What is being tested?
- Endoscopic ultrasound
- Type of treatment
- Medical device
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- Dec 2022to Sep 2025
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: IPMN patients in Peking Union Medical College Hospital and other related research centers
Who may be able to join
- Age: 18 years old or above;
- Diagnosis: Imaging examination showed the presence of intraductal papillary mucinous cystic tumor (IPMN) without high-risk features (including WF and HRS);
- The patient or family members can understand the study protocol, are willing to participate in the study, and provide written informed consent.
Who cannot join
- The patient's clinical, imaging and auxiliary examination characteristics conform to the surgical indications of the International Association of Pancreatic Diseases (IAP) 2018 guidelines, and the patient has no surgical contraindication;
- Previous history of pancreatic malignant tumor;
- There were the following worrisome features (WF) of IPMN found in the past examination: acute pancreatitis, cyst size ≥ 30mm, cyst wall thickening/strengthening, main pancreatic duct diameter of 5-9.9mm, non enhanced mural nodules, sudden change of main pancreatic duct diameter with distal pancreatic atrophy;
- The following high risk features of IPMN (HRS) were found in the past: obstructive jaundice, enhanced mural nodules or related solid components, and main pancreatic duct>10mm;
- The patient or family member could not understand the conditions and objectives of this study.
Trial locations and contacts
No sites are listed yet.
About this study
Study objective: To establish a long-term follow-up cohort of patients with IPMN, study the follow-up, clinical outcomes and prognostic factors of patients with IPMN, and provide a basis for clinical decisions and guidelines.
Study design: This is a real world, multicenter, prospective, observational cohort study
Read the detailed description
Baseline assessment will be conducted on IPMN patients who meet the inclusion conditions and are included in the study with informed consent, including: ① demographic characteristics (such as age, gender, etc.); ② Clinical features (such as symptoms, complications, past history, family history, living/eating habits); ③ Characteristics of laboratory indicators (such as pancreatic function, liver enzyme, bile duct enzyme, CA199, CEA in blood; CA199, CEA in cystic fluid, etc.); ④ Imaging features * (such as multiple or single lesions, diameter of cyst, whether there are mural nodules, diameter of main pancreatic duct, etc.); ⑤ Endoscopic ultrasound (EUS) features * (such as: cyst location, echo, maximum diameter, whether the cyst wall is thickened, wall nodules, the connection between the cyst and the main pancreatic duct, laser confocal endoscopy features, etc.); ⑥ Pathological information (cytology of cystic fluid; cytological smear of cystic lesion puncture, histopathology); ⑥ Molecular characteristics of cyst fluid (such as proteomics/mass spectrometry, new biomarkers, next generation sequencing (NGS), flora characteristics, etc.); ⑦ Treatment information (such as current medication, whether to have received endoscopic treatment, etc.).
The follow-up contents include: outpatient follow-up (symptoms, laboratory indicators; keeping peripheral blood samples) every six months;, imaging follow-up (including enhanced pancreatic MR and EUS imaging; the first pancreatic MRI follow-up was conducted 6 months after enrollment to determine the stability of the lesions) at baseline and every 12 months thereafter.
During the follow-up, if the patient died of various causes, the follow-up will be terminated; If enhanced nuclear magnetic resonance imaging or EUS imaging of the pancreas indicates worrisome features (WFs) or high-risk features (High risk stigmata, HRS), EUS-FNA ± nCLE should be performed (when performing EUS, perform contrast-enhanced ultrasonography on cystic lesions with mural nodules, and collect cystic fluid when puncturing some cystic lesions with sufficient volume).
If the cytological/histological pathological results of FNA indicate cancer or high grade dysplasia (HGD), or/and cystic fluid cytological results are positive, surgical treatment is recommended; If the FNA and cyst fluid cytology results are negative, the patients with WF will be followed up 6 months later, while the HRS patients will be followed up 3 months later (whether to accept EUS examination is decided jointly by the follow-up physician and the patient). It is suggested to review EUS-FNA ± nCLE according to the imaging results. If the patient was advised to receive surgical treatment due to IPMN, the follow-up was terminated.
- Conditions
- IPMN, Pancreatic
- Being tested
- Endoscopic ultrasound
- Keywords
- IPMN, clinical outcomes, EUS
- Medical subject headings
- Pancreatic Intraductal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ultrasoundDevice
The EUS follow-up will be conducted at baseline and every 12 months thereafter. For patients with new WF or HRS in the evaluation, the follow-up physician and the patient can jointly decide whether to perform EUS evaluation in the 6 or 3 month intensive follow-up.
What is being measured
The primary outcome is the main question the study is designed to answer.
The termination of the follow-up of IPMN patients, including death termination and recommended surgery termination.
Patient died or was recommended for surgical treatment.
Measured: 3 years
Secondary outcomes (1)
The new development of worrisome features or high-risk stigmata
High-risk stigmata refers to obstructive jaundice, enhancing mural nodules or an associated solid component, and those with an MPD ≥10 mm. Worrisome features refer to acute pancreatitis, cyst size ≥30 mm, thickened/enhancing cyst wall, MPD measuring 5-9.9 mm, nonenhancing mural nodules, and abrupt change in MPD caliber with distal atrophy of the pancreatic gland.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study startDec 2022 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IPMN, PancreaticStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Hospital, Tongji Hospital, The First Affiliated Hospital of Xiamen University
- Responsible party
- Principal investigator, Wu Xi, Peking Union Medical College Hospital
- Investigators
- Xi Wu, M.D., Study director, Peking Union Medical College HospitalShengyu Zhang, M.D., Principal investigator, Peking Union Medical College HospitalYiran Su, MD candidate, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05593393
- Sponsor's protocol ID
- K2378
- Status last verified
- Nov 2022
- First submitted
- 21 Oct 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No