Ampulla of Vater AdenomaPhase 3NCT02165852
Comparison on the Efficacy of Endoscopic Snare Papillectomy With or Without Submucosal Injection
A Phase 3 study testing Papillectomy without injection and Papillectomy with injection in people with Ampulla of Vater Adenoma, run by Soon Chun Hyang University at 1 site in South Korea.
Trial summary
Because the ampulla of Vater is strategically located at the confluence of the pancreatic and common bile ducts, endoscopic resection of papillary neoplasms may be technically different from endoscopic mucosal resection in other parts of the gastrointestinal tract. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ampulla of Vater Adenoma
- What is being tested?
- Papillectomy without injection and Papillectomy with injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2014to Oct 2015
- Phase
- Phase 3
- 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
Who may be able to join
- ampulla of Vater adenoma
- no uncontrolled coagulopathy
Who cannot join
- adenocarcinoma of ampulla of Vater
- uncontrolled coagulopathy
- refusal to this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Comparative Study of Papillectomy
Because the ampulla of Vater is strategically located at the confluence of the pancreatic and common bile ducts, endoscopic resection of papillary neoplasms may be technically different from endoscopic mucosal resection in other parts of the gastrointestinal tract. The best method of endoscopic ablation and the optimal period for surveillance have not been established.
Read the detailed description
While some endoscopists advocate the use of submucosal injection of either physiologic saline solution or dilute epinephrine, some do not. Whether physiologic saline solution or dilute epinephrine should be used is also not established. Submucosal injection of either dilute epinephrine or saline solution may be useful for avoiding inappropriate resection because failure to lift the tumor from the proper muscle layer of the duodenum may indicate deeper invasion18 and is the strongest predictor of malignancy.
In adenomas of the major duodenal papilla, however, some investigators do not recommend submucosal injection. Not only the surrounding mucosa at the region of the duodenal papilla but also the tumor is lifted by submucosal injection, so capturing the lesion with a snare becomes difficult.
- Conditions
- Ampulla of Vater Adenoma
- Being tested
- Papillectomy without injection, Papillectomy with injection
- Keywords
- ampulla of Vater, adenoma, papillectomy, injection, non-injection
- Medical subject headings
- Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Papillectomy without injectionProcedure or surgery
Conventional endoscopic mucosal resection of ampulla of Vater using a snare with electrocurrent.
Papillectomy with injectionProcedure or surgery
Conventional endoscopic mucosal resection of ampulla of Vater without submucosal saline or diluted epinephrine injection.
| Study group | Role | What they receive |
|---|---|---|
| Papillectomy without injection | Experimental | Conventional snaring mucoal resection without submucosal injection Receives: Procedure: Papillectomy without injection |
| Papillectomy with injection | Active comparator | Conventional mucosal resction method following injeciton of diluted epinephrine mixture. Receives: Procedure: Papillectomy with injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete resection
Following endoscopic papillectomy, complete resection will be estimated by pathologic examination
Measured: one month
Secondary outcomes (1)
complication
Immediate complications after papillecotmy Delayed complications during 24 hours
Measured: within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startJan 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ampulla of Vater AdenomaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soon Chun Hyang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae Hoon Lee, Soon Chun Hyang University
- Investigators
- Tae Hoon Lee, MD, PhD, Principal investigator, Soonchunhyang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02165852
- Sponsor's protocol ID
- Papillectomy Study
- Status last verified
- Oct 2015
- First submitted
- 25 Mar 2014
- Last updated
- 15 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hyun JJ, Lee TH, Park JS, Han JH, Jeong S, Park SM, Lee HS, Moon JH, Park SH. A prospective multicenter study of submucosal injection to improve endoscopic snare papillectomy for ampullary adenoma. Gastrointest Endosc. 2017 Apr;85(4):746-755. doi: 10.1016/j.gie.2016.08.013. Epub 2016 Aug 24.
PubMed 27566056
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparative Study of Papillectomy
- ClinicalTrials.gov ID
- NCT02165852
- Acronym / sponsor ID
- Papillectomy Study
- Conditions
- Ampulla of Vater Adenoma
- Keywords
- ampulla of Vater, adenoma, papillectomy, injection, non-injection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Soon Chun Hyang UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 18 Jun 2014 (estimated)
- 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.
Because the ampulla of Vater is strategically located at the confluence of the pancreatic and common bile ducts, endoscopic resection of papillary neoplasms may be technically different from endoscopic mucosal resection in other parts of the gastrointestinal tract. The best method of endoscopic ablation and the optimal period for surveillance have not been established.
Detailed description
While some endoscopists advocate the use of submucosal injection of either physiologic saline solution or dilute epinephrine, some do not. Whether physiologic saline solution or dilute epinephrine should be used is also not established. Submucosal injection of either dilute epinephrine or saline solution may be useful for avoiding inappropriate resection because failure to lift the tumor from the proper muscle layer of the duodenum may indicate deeper invasion18 and is the strongest predictor of malignancy.
In adenomas of the major duodenal papilla, however, some investigators do not recommend submucosal injection. Not only the surrounding mucosa at the region of the duodenal papilla but also the tumor is lifted by submucosal injection, so capturing the lesion with a snare becomes difficult.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Papillectomy without injection | Experimental | Procedure: Papillectomy without injectionConventional snaring mucoal resection without submucosal injection |
| Papillectomy with injection | Active comparator | Procedure: Papillectomy with injectionConventional mucosal resction method following injeciton of diluted epinephrine mixture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ampulla of Vater adenoma
- no uncontrolled coagulopathy
Key exclusion criteria (3 listed)
- adenocarcinoma of ampulla of Vater
- uncontrolled coagulopathy
- refusal to this study
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 |
|---|---|---|
| Papillectomy without injectionConventional endoscopic mucosal resection of ampulla of Vater using a snare with electrocurrent. | Procedure or surgery | Papillectomy without injection |
| Papillectomy with injectionConventional endoscopic mucosal resection of ampulla of Vater without submucosal saline or diluted epinephrine injection. | Procedure or surgery | Papillectomy with injection |
Primary outcome
complete resection
Time frame: one month
Following endoscopic papillectomy, complete resection will be estimated by pathologic examination
1 secondary outcome
complication
Time frame: within 24 hours
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 15 Oct 2015.
- Derived from this study: PubMed 27566056Hyun JJ, Lee TH, Park JS, Han JH, Jeong S, Park SM, Lee HS, Moon JH, Park SH. A prospective multicenter study of submucosal injection to improve endoscopic snare papillectomy for ampullary adenoma. Gastrointest Endosc. 2017 Apr;85(4):746-755. doi: 10.1016/j.gie.2016.08.013. Epub 2016 Aug 24.
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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.
Tae Hoon Lee, MD, PhD principal investigator
Soonchunhyang University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Papillectomy without injection and Papillectomy with injection in people with Ampulla of Vater Adenoma, run by Soon Chun Hyang University at 1 site in South Korea.
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 2 inclusion and 3 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 15 Oct 2015. 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 South Korea. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
complete resection (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02165852, which also lists 1 linked publication.
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 15 Oct 2015.