Trial · NCT07891715
Biliary Plus Pancreatic Stent vs Pancreatic Stent Alone After Endoscopic Papillectomy
NCT07891715, Not applicable, Not yet recruiting, Qilu Hospital of Shandong University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Biliary Plus Pancreatic Stent vs Pancreatic Stent Alone After Endoscopic Papillectomy. Trials, record NCT07891715. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07891715
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Biliary Plus Pancreatic Stent vs Pancreatic Stent Alone After Endoscopic Papillectomy
- NCT number
- NCT07891715
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 190 participants, estimated
- Lead sponsor
- Qilu Hospital of Shandong University
- Conditions
- Post-Procedural Complications
- Interventions
- Endoscopic papillectomy with pancreatic duct stent placement, Endoscopic papillectomy with pancreatic duct and biliary stent placement
- First posted
- 2026-10-23
- Last updated
- 2026-10-23
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall incidence of post-procedural complications | Within 30 days after the initial treatment | The primary outcome is the proportion of patients who develop at least one post-procedural complication (including bleeding, pancreatitis, cholangitis, and perforation) within 30 days after EP . Complications will be graded according to established criteria. |
| Secondary | Incidence of post-procedural pancreatitis | Within 30 days after the initial treatment | Post-procedural pancreatitis is defined as meeting at least two of the following three criteria: (1) abdominal pain characteristic of acute pancreatitis; (2) serum amylase or lipase \>3 times the upper limit of normal; (3) characteristic imaging findings of pancreatitis on CT or ultrasound. Severity will be classified as mild (interstitial edematous pancreatitis without organ failure or necrosis), moderate (transient organ failure ≤48h and/or local complications), or severe (persistent organ failure \>48h and/or death) per the revised Atlanta classification. |
| Secondary | Incidence of post-procedural bleeding | Within 30 days after the initial treatment | Post-procedural bleeding is defined as any of the following after achieving primary hemostasis: (1) overt bleeding symptoms (hematemesis, melena, hematochezia, or blood aspirated via nasogastric tube); (2) hemodynamic instability due to bleeding; (3) hemoglobin drop \>2 g/dL; (4) direct endoscopic evidence of bleeding from the papillectomy site. |
| Secondary | Incidence of post-procedural perforation | Within 30 days after the initial treatment | Post-procedural perforation is defined as evidence of transmural defect detected by emergency endoscopy, or radiological evidence of free air in the retroperitoneum or peritoneal cavity on CT scan. |
| Secondary | Incidence of post-procedural cholangitis | Within 30 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. |
| Secondary | Incidence of biliary stricture | Within 12 months after the initial treatment | EP-related biliary stricture diagnosed by CT, EUS, or MRCP during follow-up, defined as focal narrowing of the common bile duct with or without proximal dilation. |
| Secondary | Incidence of transient adverse events (TAEs) | Within 7 days after the initial treatment | Transient adverse events are temporary, reversible procedure-related injuries that do not require medical intervention and do not prolong hospital stay. Includes fever, abdominal pain, nausea, vomiting, and hyperamylasemia (elevated amylase not meeting pancreatitis criteria). |
| Secondary | Recurrence rate | At 12 months after the initial treatment | Recurrence is defined as histologically confirmed ampullary adenoma growth at follow-up endoscopy more than 3 months after initial treatment. |
| Secondary | Residual rates | Within 3 monthsafter the initial treatment | Residual is defined as histologically confirmed adenoma growth within 3 months after initial treatment. |
| Secondary | Length of hospital stay | Within 12 months after the initial treatment | Total number of calendar days spent in hospital from the date of admission for the initial treatment through 12 months after the initial treatment, including the index hospitalization and all readmissions due to disease-related symptoms or treatment-related events. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers10
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07891715
GET https://conductscience.org/api/trials/v1/NCT07891715/registered