Endoscopic Papillectomy Versus Surgery for Ampullary Tumors: A Prospective Multicenter Cohort Study
NCT07915726, Not yet recruiting, Qilu Hospital of Shandong University
Trial 9
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Endoscopic Papillectomy Versus Surgery for Ampullary Tumors: A Prospective Multicenter Cohort Study | ClinicalTrials.gov |
| NCT number | NCT07915726 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Enrollment | 306 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Qilu Hospital of Shandong University | ClinicalTrials.gov |
| Conditions | Ampullary Neoplasm, Ampullary Adenoma | ClinicalTrials.gov |
| Interventions | Endoscopic treatment group, Surgical treatment group | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Recurrence rate at 12 months | At 12 months after the initial treatment | Recurrence confirmed by endoscopic biopsy after an interval ≥ 3 months from the end of treatment, assessed at the 12-month follow-up. | ClinicalTrials.gov |
| Secondary | R0 resection rate | Periprocedural | Proportion of patients with complete resection achieved at the first endoscopic or surgical intervention and confirmed by histology (negative margins). | ClinicalTrials.gov |
| Secondary | Procedure-related adverse event rate | Up to 90 days after the initial treatment | 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. | ClinicalTrials.gov |
| Secondary | Recurrence rate at 6 months | At 6 months after the initial treatment | Recurrence confirmed by endoscopic biopsy after an interval ≥ 3 months from the end of treatment, assessed at the 6-month follow-up. | ClinicalTrials.gov |
| Secondary | Residual lesion rate | Up to 3 months after the initial treatment | Presence of residual adenoma tissue at the next endoscopy after treatment. | ClinicalTrials.gov |
| Secondary | Clinical success rate | Up to 5 years after the initial treatment | 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. | ClinicalTrials.gov |
| Secondary | Endoscopic treatment failure rate | Up to 12 months after the initial treatment | Inability to completely resect the lesion endoscopically (regardless of the number of procedures), histopathologically invasive malignancy, or recurrence no longer amenable to endoscopic treatment. | ClinicalTrials.gov |
| Secondary | Total number of readmissions within 12 months | Up to 12 months after the initial treatment | All readmissions due to disease-related symptoms (e.g., cholangitis, pancreatitis, obstructive jaundice) or treatment-related events (e.g., bleeding, perforation, anastomotic problems). | ClinicalTrials.gov |
| Secondary | Technical success rate | Periprocedural | Proportion of patients in whom the planned procedure was completed as intended. | ClinicalTrials.gov |
| Secondary | Total treatment cost | Up to 12 months after the initial treatment | All direct medical costs from admission to 12 months after the initial treatment (including procedure, anesthesia, hospitalization, medication, examinations, and readmission costs). | ClinicalTrials.gov |
| Secondary | Index hospitalization length of stay | Periprocedural | 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 | ClinicalTrials.gov |
| Secondary | Total length of stay within 12 months | Up to 12 months after the initial treatment | 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. | ClinicalTrials.gov |
| Secondary | Postprocedural pancreatitis rate | Up to 90 days after the initial treatment | 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. | ClinicalTrials.gov |
| Secondary | Postprocedural bleeding rate | Up to 90 days after the initial treatment | 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. | ClinicalTrials.gov |
| Secondary | Postprocedural perforation rate | Up to 90 days after the initial treatment | Direct visualization of a transmural defect during endoscopy, or radiographic evidence of extraluminal free air on abdominal CT or plain radiograph. | ClinicalTrials.gov |
| Secondary | Postprocedural cholangitis rate | Up to 90 days after the initial treatment | 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. | ClinicalTrials.gov |
| Secondary | Cumulative recurrence rate | Through study completion, an average of 5 years | Cumulative recurrence during annual follow-up up to 5 years | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 8
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)