Clinical trial · Observational

A Long-term Follow-up Cohort Study in Patients With Intraductal Papillary Mucinous Neoplasm

NCT05593393CI-TRIAL-00062141unknownClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
IPMN, Pancreatic	Pancreatic Intraductal Papillary Mucinous Neoplasm	ALIAS	0.90

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Endoscopic ultrasound	Device	—	UNRESOLVED

Design

Arms and outcomes

Arms (0)

[]

Primary outcomes (1)

measure
The termination of the follow-up of IPMN patients, including death termination and recommended surgery termination.
timeFrame
3 years
description
Patient died or was recommended for surgical treatment.

Secondary outcomes (1)

measure
The new development of worrisome features or high-risk stigmata
timeFrame
3 years
description
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.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

1. Age: 18 years old or above;
2. Diagnosis: Imaging examination showed the presence of intraductal papillary mucinous cystic tumor (IPMN) without high-risk features (including WF and HRS);
3. The patient or family members can understand the study protocol, are willing to participate in the study, and provide written informed consent.

Exclusion Criteria:

1. 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;
2. Previous history of pancreatic malignant tumor;
3. 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;
4. 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;
5. The patient or family member could not understand the conditions and objectives of this study.

References

Publications (0)

Data not yet available

No reference posted for this study.