Duodenal AdenomaNCT06301048
Effectiveness of Endoscopic Papillectomy With Stent for Treating Duodenal Papillary Adenoma
An observational study of Duodenal Adenoma and Complication of Treatment, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
This is a retrospective study, including 79 patients with duodenal papillary adenoma, who treated with Endoscopic Papillectomy (EP) at Beijing friendship hospital. The cohort included patients who underwent EP with or without Pancreatic Duct (PD) and Common Bile Duct (CBD) stent placement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Duodenal Adenoma, Complication of Treatment
- What is being tested?
- Stent Placement in Pancreatic and Bile Ducts
- Type of treatment
- Surgery or procedure
- How many people
- 79 participants
- Where
- 1 siteChina
- Study dates
- 7 Nov 2023to 7 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who diagnosed with duodenal papillary adenoma underwent endoscopic papillectomy and optionally complemented by pancreatic and biliary stent placement at Beijing Friendship Hospital.
Who may be able to join
- Age ≥18 years.
- Identification of duodenal papillary lesions via gastroscopy or duodenoscopy.
- Intraductal involvement <20mm.
- Absence of preoperative peripheral lymph node metastasis and pancreatic/biliary duct stenosis (verified by CT, MRI, or other imaging).
- Postoperative biopsy confirming adenoma.
Who cannot join
- Diagnosis of familial adenomatous polyposis or multiple hamartoma syndrome.
- Patients undergoing pancreaticoduodenectomy within a month post-EP for residual lesions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Endoscopic Papillectomy With Stent Placement in Pancreatic and Bile Ducts for Treating Duodenal Papillary Adenoma
This is a retrospective study, including 79 patients with duodenal papillary adenoma, who treated with Endoscopic Papillectomy (EP) at Beijing friendship hospital. The cohort included patients who underwent EP with or without Pancreatic Duct (PD) and Common Bile Duct (CBD) stent placement. The investigators assessed the outcomes of EP and the impact of stent placement on complications and recurrence rates.
Read the detailed description
Duodenal papillary adenoma, a potentially malignant benign tumor is primarily treated with endoscopic papillectomy. Despite its efficacy, endoscopic papillectomy has a high complication rate. This study investigates whether pancreatic duct and common bile duct stent placement can mitigate these complications. In a retrospective analysis, 79 patients with duodenal papillary adenoma, treated with endoscopic papillectomy at our center, were studied. The cohort included patients who underwent endoscopic papillectomy with no stents placement, common bile duct stent placement alone, pancreatic duct stent placement alone, or stents placement in both ducts. Complete resection rates did not significantly differ between patients with or without stent placement. Early complication rates were similar across groups. However, significant reduction in common bile duct stenosis was observed in the stenting group. Furthermore, stent placement correlated with lower adenoma recurrence rates during follow-up. Thus, Pancreatic duct and common bile duct stent placement in endoscopic papillectomy may decrease late complications, particularly common bile duct stenosis, and reduce the recurrence of duodenal papillary adenoma.
- Conditions
- Duodenal Adenoma, Complication of Treatment
- Being tested
- Stent Placement in Pancreatic and Bile Ducts
- Keywords
- Duodenal papillary adenoma, Endoscopic duodenal papillectomy, Pancreatic duct stent, Common bile duct stent, Complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stent Placement in Pancreatic and Bile DuctsProcedure or surgery
Post-resection, endoscopic retrograde cholangiopancreatography (ERCP) was performed for stent placement in pancreatic or bile ducts as needed, with X-ray confirmation of stent positioning.
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic Stenting Group | performed pancreatic duct stent placement after endoscopic papillectomy Receives: Procedure: Stent Placement in Pancreatic and Bile Ducts | |
| Non-Pancreatic Stenting Group | have not performed pancreatic duct stent placement after endoscopic papillectomy | |
| Biliary Stenting Group | performed common bile duct stent placement after endoscopic papillectomy Receives: Procedure: Stent Placement in Pancreatic and Bile Ducts | |
| Non-Biliary Stenting Group | have not performed common bile duct stent placement after endoscopic papillectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complications
Complications related with Endoscopic Papillectomy (EP), including pancreatitis, cholangitis, bleeding, perforation, hyperamylasemia, stenosis. The results of intraoperative endoscopic observation, postoperative symptoms and signs, blood routine examination, amylase, lipase, and imaging and endoscopic examination during follow-up were measured.
Measured: through study completion, an average of 1 year
Rate of complete resection
The pathological margins results were used to determine whether the lesion was completely resected.
Measured: 1 week after the operation
Secondary outcomes (1)
Rate of recurrence
Endoscopic observation and biopsy results were used to find recurrence.
Measured: Within 3 years after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start7 Nov 2023
- Primary completion7 Dec 2023
- Study completion7 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duodenal AdenomaStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fujing Lv, M.D., Study director, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06301048
- Sponsor's protocol ID
- BFHHZS20230203
- Status last verified
- Jan 2024
- First submitted
- 18 Feb 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Endoscopic Papillectomy With Stent Placement in Pancreatic and Bile Ducts for Treating Duodenal Papillary Adenoma
- ClinicalTrials.gov ID
- NCT06301048
- Acronym / sponsor ID
- BFHHZS20230203
- Conditions
- Duodenal Adenoma, Complication of Treatment
- Keywords
- Duodenal papillary adenoma, Endoscopic duodenal papillectomy, Pancreatic duct stent, Common bile duct stent, Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- 7 Dec 2023 (actual)
- Study completion
- 7 Dec 2023 (actual)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a retrospective study, including 79 patients with duodenal papillary adenoma, who treated with Endoscopic Papillectomy (EP) at Beijing friendship hospital. The cohort included patients who underwent EP with or without Pancreatic Duct (PD) and Common Bile Duct (CBD) stent placement. The investigators assessed the outcomes of EP and the impact of stent placement on complications and recurrence rates.
Detailed description
Duodenal papillary adenoma, a potentially malignant benign tumor is primarily treated with endoscopic papillectomy. Despite its efficacy, endoscopic papillectomy has a high complication rate. This study investigates whether pancreatic duct and common bile duct stent placement can mitigate these complications. In a retrospective analysis, 79 patients with duodenal papillary adenoma, treated with endoscopic papillectomy at our center, were studied. The cohort included patients who underwent endoscopic papillectomy with no stents placement, common bile duct stent placement alone, pancreatic duct stent placement alone, or stents placement in both ducts. Complete resection rates did not significantly differ between patients with or without stent placement. Early complication rates were similar across groups. However, significant reduction in common bile duct stenosis was observed in the stenting group. Furthermore, stent placement correlated with lower adenoma recurrence rates during follow-up. Thus, Pancreatic duct and common bile duct stent placement in endoscopic papillectomy may decrease late complications, particularly common bile duct stenosis, and reduce the recurrence of duodenal papillary adenoma.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pancreatic Stenting Group | – | Procedure: Stent Placement in Pancreatic and Bile Ductsperformed pancreatic duct stent placement after endoscopic papillectomy |
| Non-Pancreatic Stenting Group | – | –have not performed pancreatic duct stent placement after endoscopic papillectomy |
| Biliary Stenting Group | – | Procedure: Stent Placement in Pancreatic and Bile Ductsperformed common bile duct stent placement after endoscopic papillectomy |
| Non-Biliary Stenting Group | – | –have not performed common bile duct stent placement after endoscopic papillectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who diagnosed with duodenal papillary adenoma underwent endoscopic papillectomy and optionally complemented by pancreatic and biliary stent placement at Beijing Friendship Hospital.
Key inclusion criteria (5 listed)
- Age ≥18 years.
- Identification of duodenal papillary lesions via gastroscopy or duodenoscopy.
- Intraductal involvement <20mm.
- Absence of preoperative peripheral lymph node metastasis and pancreatic/biliary duct stenosis (verified by CT, MRI, or other imaging).
- Postoperative biopsy confirming adenoma.
Key exclusion criteria (2 listed)
- Diagnosis of familial adenomatous polyposis or multiple hamartoma syndrome.
- Patients undergoing pancreaticoduodenectomy within a month post-EP for residual lesions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stent Placement in Pancreatic and Bile DuctsPost-resection, endoscopic retrograde cholangiopancreatography (ERCP) was performed for stent placement in pancreatic or bile ducts as needed, with X-ray confirmation of stent positioning. | Procedure or surgery | Biliary Stenting Group, Pancreatic Stenting Group |
Primary outcome
Rate of complications
Time frame: through study completion, an average of 1 year
Complications related with Endoscopic Papillectomy (EP), including pancreatitis, cholangitis, bleeding, perforation, hyperamylasemia, stenosis. The results of intraoperative endoscopic observation, postoperative symptoms and signs, blood routine examination, amylase, lipase, and imaging and endoscopic examination during follow-up were measured.
Rate of complete resection
Time frame: 1 week after the operation
The pathological margins results were used to determine whether the lesion was completely resected.
1 secondary outcome
Rate of recurrence
Time frame: Within 3 years after the operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fujing Lv, M.D. study director
Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Duodenal Adenoma and Complication of Treatment, run by Beijing Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of complications (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.