An observational study in Ampullary Neoplasm and Ampullary Adenoma, sponsored by Qilu Hospital of Shandong University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Qilu Hospital of Shandong University · Observational
The aim of this study is to compare the efficacy and safety of endoscopic treatment (endoscopic papillectomy [EP] with or without intraductal radiofrequency ablation [RFA]) and surgical treatment (transduodenal ampullectomy [TSA] and pancreatoduodenectomy [PD]) in patients with ampullary tumors (ampullary adenoma and early ampullary carcinoma), focusing on residual disease, recurrence, postoperative complications, and overall costs.
This is a multicenter, two-arm, prospective cohort study. The diagnosis of ampullary adenoma must be confirmed by biopsy.
The endoscopic treatment group receives EP; patients without intraductal extension receive EP alone, while patients with intraductal extension receive additional RFA in the same or a subsequent session. The surgical treatment group receives TSA or PD. Patients are followed up at 3, 6, and 12 months after the initial treatment, then annually for at least 5 years, with side-viewing duodenoscopy, targeted biopsy, and CT assessment. To control confounding between the two groups, propensity score matching and inverse probability of treatment weighting will be applied.
Qilu Hospital of Shandong University is the lead sponsor of 310 studies on the registry; 188 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients with histologically confirmed ampullary adenoma or early ampullary carcinoma (Tis/T1) without invasion into the duodenal muscularis propria, staged M0/N0 by EUS , MRCP and CT , with intraductal tumor extension ≤ 20 mm on EUS, MRCP, or IDUS, undergoing endoscopic papillectomy or surgery.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergoing EP with or without RFA.
Procedure: Endoscopic treatment group
Patients undergoing surgical treatment.
Procedure: Surgical treatment group
Endoscopic papillectomy (EP); EP combined with intraductal RFA for lesions with intraductal tumor extension.
TSA or PD
Recurrence rate at 12 months
Recurrence confirmed by endoscopic biopsy after an interval ≥ 3 months from the end of treatment, assessed at the 12-month follow-up.
Time frame: At 12 months after the initial treatment
R0 resection rate
Proportion of patients with complete resection achieved at the first endoscopic or surgical intervention and confirmed by histology (negative margins).
Time frame: Periprocedural
Procedure-related adverse event rate
Proportion of patients who experienced at least one adverse event attributable to the initial endoscopic or surgical procedure within 30 days after the procedure, irrespective of severity.
Time frame: Up to 90 days after the initial treatment
Recurrence rate at 6 months
Recurrence confirmed by endoscopic biopsy after an interval ≥ 3 months from the end of treatment, assessed at the 6-month follow-up.
Time frame: At 6 months after the initial treatment
Residual lesion rate
Presence of residual adenoma tissue at the next endoscopy after treatment.
Time frame: Up to 3 months after the initial treatment
Clinical success rate
Proportion of patients who achieved complete excision of the lesion (regardless of the number of procedures) with no histologically confirmed adenoma regrowth, no evidence of invasive cancer, and without the need for surgical resection, during follow-up up to 5 years after the initial treatment.
Time frame: Up to 5 years after the initial treatment
Endoscopic treatment failure rate
Inability to completely resect the lesion endoscopically (regardless of the number of procedures), histopathologically invasive malignancy, or recurrence no longer amenable to endoscopic treatment.
Time frame: Up to 12 months after the initial treatment
Total number of readmissions within 12 months
All readmissions due to disease-related symptoms (e.g., cholangitis, pancreatitis, obstructive jaundice) or treatment-related events (e.g., bleeding, perforation, anastomotic problems).
Time frame: Up to 12 months after the initial treatment
Technical success rate
Proportion of patients in whom the planned procedure was completed as intended.
Time frame: Periprocedural
Total treatment cost
All direct medical costs from admission to 12 months after the initial treatment (including procedure, anesthesia, hospitalization, medication, examinations, and readmission costs).
Time frame: Up to 12 months after the initial treatment
Index hospitalization length of stay
Number of calendar days from the date of admission for the initial treatment to the date of discharge for the initial treatment,including the day of admission
Time frame: Periprocedural
Total length of stay within 12 months
Total number of calendar days spent in hospital within 12 months after the initial treatment, including the index hospitalization and all readmissions due to disease-related symptoms or treatment-related events.
Time frame: Up to 12 months after the initial treatment
Postprocedural pancreatitis rate
Defined by two of three criteria: characteristic abdominal pain; amylase or lipase \> 3× upper limit of normal; imaging features of pancreatitis; severity graded mild / moderate / severe per protocol.
Time frame: Up to 90 days after the initial treatment
Postprocedural bleeding rate
Proportion of patients with clinically significant post-procedural bleeding within 30 days after the procedure, defined as any of the following after achieving primary haemostasis: overt bleeding symptoms (hematemesis, melena, hematochezia, or blood aspirated via nasogastric tube); haemodynamic instability attributable to bleeding; a decrease in haemoglobin greater than 2 g/dL; or direct endoscopic evidence of bleeding from the papillectomy site.
Time frame: Up to 90 days after the initial treatment
Postprocedural perforation rate
Direct visualization of a transmural defect during endoscopy, or radiographic evidence of extraluminal free air on abdominal CT or plain radiograph.
Time frame: Up to 90 days after the initial treatment
Postprocedural cholangitis rate
New onset temperature \>38 °C for more than 24 hours combined with cholestasis. Severity will be graded separately according to the TG18 severity classification (Grade I / II / III) and reported descriptively.
Time frame: Up to 90 days after the initial treatment
Cumulative recurrence rate
Cumulative recurrence during annual follow-up up to 5 years
Time frame: Through study completion, an average of 5 years
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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