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Clinical characteristics of ampullary tumors and analysis of the efficacy and safety of endoscopic papillectomy

Clinical characteristics of ampullary tumors and analysis of the efficacy and safety of endoscopic papillectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500112237
Enrollment
Unknown
Registered
2025-11-11
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ampullary carcinomas

Interventions

Case group:None
Control Group:None

Sponsors

Department of Gastroenterology, The First Medical Center of Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Case group Confirmed diagnosis of ampullary tumors (including adenomas, low-grade intraepithelial neoplasia, high-grade intraepithelial neoplasia, and adenocarcinoma) by endoscopic biopsy or postoperative pathology; Aged 18-80 years old, regardless of gender; Meeting the indications for endoscopic papillectomy (EP): The tumor is confined to the ampulla without invasion of surrounding tissues (Tis/T1 stage); Imaging examinations (EUS/MRCP/CT) show no evidence of regional lymph node metastasis or distant metastasis; No contraindications to endoscopic treatment (such as coagulation disorders, severe cardiopulmonary diseases). Having signed the informed consent form, voluntarily participating in the study and accepting long-term follow-up. Control Group (Healthy Individuals/Patients with Non-neoplastic Hepatobiliary and Pancreatic Diseases): Matched with the case group by age (±5 years) and gender; No medical history of ampullary tumors or other gastrointestinal tumors; For patients with non-neoplastic hepatobiliary and pancreatic diseases, ampullary space-occupying lesions must be excluded by imaging or endoscopy; Signed the informed consent form and voluntarily provided baseline data.

Exclusion criteria

Exclusion criteria: Case group Complicated with other malignant tumors of the digestive tract, or the ampullary tumor is a metastatic lesion; A history of ampullary surgery or radiotherapy. Complicated with severe cardiac, hepatic or renal insufficiency. Pregnant or lactating women. Inability to cooperate with follow-up (e.g., having mental illness, living in a remote area). Control Group Having a history of malignant tumors; Complicated with severe systemic diseases (such as end-stage renal disease, advanced liver cirrhosis)

Design outcomes

Primary

MeasureTime frame
Risk factors;Recurrence rate;

Secondary

MeasureTime frame
Protective factor;Overall survival rate;Progression-free survival rate;Complication rate;

Countries

China

Contacts

Public ContactChai Ningli

Department of Gastroenterology, The First Medical Center of Chinese PLA General Hospital

chainingli@vip.163.com+86 150 1136 2982

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026