Ampulla of Vater NeoplasmsNCT07446543
Effect of Negative-Pressure Drainage Versus Pancreatic Duct Stenting for Preventing Pancreatitis After Endoscopic Papillectomy for Duodenal Papillary Tumors
A study testing Placement of a negative pressure drainage tube and Placement of a pancreatic duct stent in people with Ampulla of Vater Neoplasms and Ampullary Adenoma, run by Cui Xiaobing.
Trial summary
This prospective, multicenter, randomized controlled trial aims to evaluate the effectiveness of negative-pressure duodenal drainage compared with prophylactic pancreatic duct stenting in preventing post-endoscopic papillectomy (EP) pancreatitis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ampulla of Vater Neoplasms, Ampullary Adenoma, Ampullary Carcinoma
- What is being tested?
- Placement of a negative pressure drainage tube and Placement of a pancreatic duct stent
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2026to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years
- Preoperative diagnosis of duodenal papillary adenoma or early-stage adenocarcinoma (≤T1a)
- Scheduled to undergo endoscopic papillectomy
Who cannot join
- Preoperative diagnosis suggestive of adenocarcinoma ≥T1b stage.
- Preoperative imaging indicating intraductal extension into the pancreatic or bile duct ≥20 mm.
- Lesion diameter >40 mm, location adjacent to a duodenal diverticulum, or other anatomical or technical factors deemed unsuitable for endoscopic resection.
- Known familial adenomatous polyposis (FAP).
- Severe cardiopulmonary disease precluding tolerance of anesthesia or endoscopic procedures.
- Coagulopathy or bleeding disorders.
- Pregnancy or lactation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
kaiyun liu contact
About this study
Official title: Effect of Negative-Pressure Drainage Versus Pancreatic Duct Stenting for Preventing Pancreatitis After Endoscopic Papillectomy for Duodenal Papillary Tumors: A Prospective, Multicenter, Randomized Controlled Trial
This prospective, multicenter, randomized controlled trial aims to evaluate the effectiveness of negative-pressure duodenal drainage compared with prophylactic pancreatic duct stenting in preventing post-endoscopic papillectomy (EP) pancreatitis. Eligible patients undergoing EP will be randomized 1:1 to receive either negative-pressure drainage or pancreatic duct stenting. The primary outcome is the incidence of post-EP pancreatitis. Secondary outcomes include other procedure-related complications, procedure time, technical success, length of hospital stay, hospitalization cost, en-bloc and R0 resection rates, and postoperative hyperamylasemia.
Read the detailed description
This study is a prospective, multicenter, open-label, randomized controlled trial designed to evaluate two postoperative drainage strategies following endoscopic papillectomy (EP). Patients scheduled for EP for duodenal papillary neoplasms will be screened according to predefined inclusion and exclusion criteria. After providing written informed consent, eligible participants will be randomized in a 1:1 ratio to the negative-pressure drainage group or the pancreatic duct stent group.
All participants will undergo standardized EP performed by experienced endoscopists. According to group assignment, either a nasally inserted negative-pressure drainage tube or a prophylactic pancreatic duct stent will be placed intraoperatively. Postoperative management includes intravenous fluids and nutritional support, fasting for the first 48 hours, and routine medications to prevent infection, pancreatitis, and bleeding. Diet will be gradually resumed based on clinical and imaging assessments.
Throughout hospitalization, key clinical outcomes will be recorded, including the incidence of post-EP pancreatitis, other procedure-related complications, procedure time, technical success, length of hospital stay, total hospitalization cost, resection quality (en-bloc and R0 resection rates), and postoperative hyperamylasemia. All participants will undergo inpatient postoperative monitoring and a scheduled 1-month follow-up visit to collect clinical status, laboratory results, and device-related information.
The study team will perform statistical analyses based on follow-up data to compare the efficacy and safety of the two drainage strategies. The findings are expected to clarify the clinical value of negative-pressure duodenal drainage and provide evidence to guide optimization of postoperative management after endoscopic papillectomy.
- Being tested
- Placement of a negative pressure drainage tube, Placement of a pancreatic duct stent
- Keywords
- endoscopic papillectomy, ampullary tumor, negative-pressure drainage, pancreatic duct stent, randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of a negative pressure drainage tubeDevice
A flexible polymer drainage tube is inserted transnasally immediately after endoscopic papillectomy and advanced so that the tip rests distal to the papilla in the descending duodenum. The external end is connected to a manual suction device to provide continuous negative pressure and promote evacuation of pancreatic secretions and duodenal contents. The tube is monitored for function, displacement, and blockage and is removed approximately 72 hours postprocedure if no significant complications occur. Rescue therapy: in the event of significant intraoperative bleeding, perforation, or other device-related complications, a pancreatic duct stent may be placed while maintaining the negative-pressure tube for continued drainage.
Placement of a pancreatic duct stentProcedure or surgery
A plastic pancreatic duct stent is placed under endoscopic and fluoroscopic guidance immediately after endoscopic papillectomy to facilitate pancreatic drainage and reduce the risk of postoperative pancreatitis. Stent diameter and length are selected by the endoscopist based on intraoperative findings and preoperative imaging. If stent placement fails after three or more attempts or cumulative placement time exceeds 15 minutes, the procedure is considered unsuccessful and a nasally inserted negative-pressure drainage tube will be used as rescue therapy. Successfully placed stents are scheduled for endoscopic removal within 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Negative Pressure Drainage Group | Experimental | Participants undergo endoscopic papillectomy followed by intraoperative placement of a nasally inserted negative-pressure drainage tube positioned distal to the papilla in the descending duodenum. Continuous negative suction is applied to facilitate pancreatic and duodenal drainage. Receives: Device: Placement of a negative pressure drainage tube |
| Pancreatic Duct Stenting Group | Active comparator | Participants undergo endoscopic papillectomy followed by prophylactic placement of a plastic pancreatic duct stent under endoscopic and fluoroscopic guidance to promote pancreatic drainage and reduce the risk of postoperative pancreatitis. Receives: Procedure: Placement of a pancreatic duct stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post-endoscopic papillectomy pancreatitis
Diagnosis will be based on the revised Atlanta classification, incorporating clinical symptoms (abdominal pain), laboratory findings (serum amylase or lipase ≥3 times the upper limit of normal), and imaging evidence (CT or MRI indicating pancreatitis). Daily assessment and documentation will be performed by study physicians.
Measured: Postoperative days 1, 2, and 3 (assessed daily); from postoperative day 4 through hospital discharge from the index hospitalization, assessed as clinically indicated (when pancreatitis is suspected)
Secondary outcomes (8)
R0 resection rate (complete resection)
R0 resection will be determined based on the pathology report, defined as histologically negative resection margins. Final assessment will be made by the pathologist.
Measured: At final pathology assessment (upon pathology report issuance; typically within 7 days after endoscopic papillectomy）
Technical success rate of intended drainage placement
Defined as successful completion of the initially assigned drainage method (negative pressure drainage or pancreatic duct stenting) without intraoperative crossover. For pancreatic duct stenting, technical success requires successful pancreatic duct cannulation and stent deployment. For negative pressure drainage, technical success requires successful placement of the drainage tube at the intended duodenal position with effective negative pressure suction. Determined and recorded by the endoscopist during the procedure.
Measured: During the endoscopic papillectomy procedure (Day 0), assessed immediately after attempted completion of the assigned drainage method
Incidence of hyperamylasemia
Serum amylase levels will be measured at scheduled postoperative timepoints. Hyperamylasemia is defined as an elevation above the upper limit of normal in the absence of clinical signs of pancreatitis. Diagnosis is based on laboratory results and recorded in the case report form (CRF).
Measured: 6 hours, 24 hours, and 48 hours after endoscopic papillectomy.
Length of hospital stay
Length of hospital stay will be calculated from the date of admission to the date of discharge, measured in days and extracted from the hospital medical record system.
Measured: From admission to hospital discharge (up to 7 days)
En bloc resection rate
Defined as whether the lesion was resected in a single piece. Determination is made postoperatively by the endoscopist and confirmed immediately through gross inspection of the resected specimen.
Measured: Immediately after lesion resection during the endoscopic papillectomy procedure (Day 0)
Incidence of postoperative complications
Postoperative complications-including bleeding, perforation, and infection (e.g., cholangitis)-will be recorded based on clinical diagnostic criteria and medical records. Assessment will be performed by study physicians and documented in the case report form (CRF).
Measured: From completion of endoscopic papillectomy (Day 0) through postoperative day 30 (±7 days).
Duration of endoscopic papillectomy (EP)
Measured from the time the endoscope enters the duodenum to the completion of lesion resection and any intraoperative adjunct procedures (e.g., hemostasis, drainage device placement). Duration is recorded by the operating endoscopist
Measured: During the endoscopic papillectomy procedure (Day 0), recorded immediately after procedure completion
Total hospitalization cost
Total hospitalization cost will be obtained from the hospital billing system and recorded in Chinese Yuan (RMB) by the study coordinator.
Measured: From admission to hospital discharge (up to 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start20 Mar 2026 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ampulla of Vater NeoplasmsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1 to one of two parallel groups: negative-pressure drainage or pancreatic duct stenting. All participants will undergo standardized endoscopic papillectomy (EP) performed by experienced endoscopists. In the experimental arm, a nasally inserted negative-pressure drainage tube will be positioned distal to the papilla in the descending duodenum and connected to a manual suction device to provide continuous drainage; in the comparator arm, a prophylactic pancreatic duct stent will be placed after EP. The trial will compare the two groups with respect to the primary outcome (incidence of post-EP pancreatitis) and secondary outcomes (other procedure-related complications, procedure and device-placement time, technical success rate, resection quality including en-bloc and R0 rates, length of hospital stay and total hospitalization cost, and postoperative hyperamylasemia). This is an open-label study; imaging review and statistical analysis will be performed b
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cui Xiaobing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cui Xiaobing, Shenzhen Hospital of Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446543
- Sponsor's protocol ID
- NYSZYYEC2025K110R002
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Negative-Pressure Drainage Versus Pancreatic Duct Stenting for Preventing Pancreatitis After Endoscopic Papillectomy for Duodenal Papillary Tumors: A Prospective, Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07446543
- Acronym / sponsor ID
- NYSZYYEC2025K110R002
- Keywords
- endoscopic papillectomy, ampullary tumor, negative-pressure drainage, pancreatic duct stent, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Cui XiaobingUniversity, hospital or other
- Study start
- 20 Mar 2026 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 3 Mar 2026 (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 prospective, multicenter, randomized controlled trial aims to evaluate the effectiveness of negative-pressure duodenal drainage compared with prophylactic pancreatic duct stenting in preventing post-endoscopic papillectomy (EP) pancreatitis. Eligible patients undergoing EP will be randomized 1:1 to receive either negative-pressure drainage or pancreatic duct stenting. The primary outcome is the incidence of post-EP pancreatitis. Secondary outcomes include other procedure-related complications, procedure time, technical success, length of hospital stay, hospitalization cost, en-bloc and R0 resection rates, and postoperative hyperamylasemia.
Detailed description
This study is a prospective, multicenter, open-label, randomized controlled trial designed to evaluate two postoperative drainage strategies following endoscopic papillectomy (EP). Patients scheduled for EP for duodenal papillary neoplasms will be screened according to predefined inclusion and exclusion criteria. After providing written informed consent, eligible participants will be randomized in a 1:1 ratio to the negative-pressure drainage group or the pancreatic duct stent group.
All participants will undergo standardized EP performed by experienced endoscopists. According to group assignment, either a nasally inserted negative-pressure drainage tube or a prophylactic pancreatic duct stent will be placed intraoperatively. Postoperative management includes intravenous fluids and nutritional support, fasting for the first 48 hours, and routine medications to prevent infection, pancreatitis, and bleeding. Diet will be gradually resumed based on clinical and imaging assessments.
Throughout hospitalization, key clinical outcomes will be recorded, including the incidence of post-EP pancreatitis, other procedure-related complications, procedure time, technical success, length of hospital stay, total hospitalization cost, resection quality (en-bloc and R0 resection rates), and postoperative hyperamylasemia. All participants will undergo inpatient postoperative monitoring and a scheduled 1-month follow-up visit to collect clinical status, laboratory results, and device-related information.
The study team will perform statistical analyses based on follow-up data to compare the efficacy and safety of the two drainage strategies. The findings are expected to clarify the clinical value of negative-pressure duodenal drainage and provide evidence to guide optimization of postoperative management after endoscopic papillectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 to one of two parallel groups: negative-pressure drainage or pancreatic duct stenting. All participants will undergo standardized endoscopic papillectomy (EP) performed by experienced endoscopists. In the experimental arm, a nasally inserted negative-pressure drainage tube will be positioned distal to the papilla in the descending duodenum and connected to a manual suction device to provide continuous drainage; in the comparator arm, a prophylactic pancreatic duct stent will be placed after EP. The trial will compare the two groups with respect to the primary outcome (incidence of post-EP pancreatitis) and secondary outcomes (other procedure-related complications, procedure and device-placement time, technical success rate, resection quality including en-bloc and R0 rates, length of hospital stay and total hospitalization cost, and postoperative hyperamylasemia). This is an open-label study; imaging review and statistical analysis will be performed b
| Arm | Type | Receives |
|---|---|---|
| Negative Pressure Drainage Group | Experimental | Device: Placement of a negative pressure drainage tubeParticipants undergo endoscopic papillectomy followed by intraoperative placement of a nasally inserted negative-pressure drainage tube positioned distal to the papilla in the descending duodenum. Continuous negative suction is applied to facilitate pancreatic and duodenal drainage. |
| Pancreatic Duct Stenting Group | Active comparator | Procedure: Placement of a pancreatic duct stentParticipants undergo endoscopic papillectomy followed by prophylactic placement of a plastic pancreatic duct stent under endoscopic and fluoroscopic guidance to promote pancreatic drainage and reduce the risk of postoperative pancreatitis. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 75 years
- Preoperative diagnosis of duodenal papillary adenoma or early-stage adenocarcinoma (≤T1a)
- Scheduled to undergo endoscopic papillectomy
Key exclusion criteria (7 listed)
- Preoperative diagnosis suggestive of adenocarcinoma ≥T1b stage.
- Preoperative imaging indicating intraductal extension into the pancreatic or bile duct ≥20 mm.
- Lesion diameter >40 mm, location adjacent to a duodenal diverticulum, or other anatomical or technical factors deemed unsuitable for endoscopic resection.
- Known familial adenomatous polyposis (FAP).
- Severe cardiopulmonary disease precluding tolerance of anesthesia or endoscopic procedures.
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 |
|---|---|---|
| Placement of a negative pressure drainage tubeA flexible polymer drainage tube is inserted transnasally immediately after endoscopic papillectomy and advanced so that the tip rests distal to the papilla in the descending duodenum. The external end is connected to a manual suction device to provide continuous negative pressure and promote evacuation of pancreatic secretions and duodenal contents. The tube is monitored for function, displacement, and blockage and is removed approximately 72 hours postprocedure if no significant complications occur. Rescue therapy: in the event of significant intraoperative bleeding, perforation, or other device-related complications, a pancreatic duct stent may be placed while maintaining the negative-pressure tube for continued drainage. | Device | Negative Pressure Drainage Group |
| Placement of a pancreatic duct stentA plastic pancreatic duct stent is placed under endoscopic and fluoroscopic guidance immediately after endoscopic papillectomy to facilitate pancreatic drainage and reduce the risk of postoperative pancreatitis. Stent diameter and length are selected by the endoscopist based on intraoperative findings and preoperative imaging. If stent placement fails after three or more attempts or cumulative placement time exceeds 15 minutes, the procedure is considered unsuccessful and a nasally inserted negative-pressure drainage tube will be used as rescue therapy. Successfully placed stents are scheduled for endoscopic removal within 30 days. | Procedure or surgery | Pancreatic Duct Stenting Group |
Primary outcome
Incidence of post-endoscopic papillectomy pancreatitis
Time frame: Postoperative days 1, 2, and 3 (assessed daily); from postoperative day 4 through hospital discharge from the index hospitalization, assessed as clinically indicated (when pancreatitis is suspected)
Diagnosis will be based on the revised Atlanta classification, incorporating clinical symptoms (abdominal pain), laboratory findings (serum amylase or lipase ≥3 times the upper limit of normal), and imaging evidence (CT or MRI indicating pancreatitis). Daily assessment and documentation will be performed by study physicians.
8 secondary outcomes
R0 resection rate (complete resection)
Time frame: At final pathology assessment (upon pathology report issuance; typically within 7 days after endoscopic papillectomy）
Technical success rate of intended drainage placement
Time frame: During the endoscopic papillectomy procedure (Day 0), assessed immediately after attempted completion of the assigned drainage method
Incidence of hyperamylasemia
Time frame: 6 hours, 24 hours, and 48 hours after endoscopic papillectomy.
Length of hospital stay
Time frame: From admission to hospital discharge (up to 7 days)
En bloc resection rate
Time frame: Immediately after lesion resection during the endoscopic papillectomy procedure (Day 0)
Incidence of postoperative complications
Time frame: From completion of endoscopic papillectomy (Day 0) through postoperative day 30 (±7 days).
Duration of endoscopic papillectomy (EP)
Time frame: During the endoscopic papillectomy procedure (Day 0), recorded immediately after procedure completion
Total hospitalization cost
Time frame: From admission to hospital discharge (up to 7 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No
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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.
kaiyun liu contact
Questions about this trial
What is this clinical trial studying?
A study testing Placement of a negative pressure drainage tube and Placement of a pancreatic duct stent in people with Ampulla of Vater Neoplasms and Ampullary Adenoma, run by Cui Xiaobing.
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 3 inclusion and 7 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: opening soon, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact xiaobing cui (+8613631312723, xbing119@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of post-endoscopic papillectomy pancreatitis (time frame: Postoperative days 1, 2, and 3 (assessed daily); from postoperative day 4 through hospital discharge from the index hospitalization, assessed as clinically indicated (when pancreatitis is suspected)). 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 4 Mar 2026.