Ampulla of Vater Neoplasms, Ampullary Adenoma, Ampullary Carcinoma
Conditions
Keywords
endoscopic papillectomy, ampullary tumor, negative-pressure drainage, pancreatic duct stent, randomized controlled trial
Brief 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. 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.
Interventions
DEVICEPlacement of a negative pressure drainage tube
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.
PROCEDUREPlacement of a pancreatic duct stent
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.
Sponsors
Cui Xiaobing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18 and 75 years 2. Preoperative diagnosis of duodenal papillary adenoma or early-stage adenocarcinoma (≤T1a) 3. Scheduled to undergo endoscopic papillectomy
Exclusion criteria
1. Preoperative diagnosis suggestive of adenocarcinoma ≥T1b stage. 2. Preoperative imaging indicating intraductal extension into the pancreatic or bile duct ≥20 mm. 3. Lesion diameter \>40 mm, location adjacent to a duodenal diverticulum, or other anatomical or technical factors deemed unsuitable for endoscopic resection. 4. Known familial adenomatous polyposis (FAP). 5. Severe cardiopulmonary disease precluding tolerance of anesthesia or endoscopic procedures. 6. Coagulopathy or bleeding disorders. 7. Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of post-endoscopic papillectomy pancreatitis | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| R0 resection rate (complete resection) | At final pathology assessment (upon pathology report issuance; typically within 7 days after endoscopic papillectomy） | R0 resection will be determined based on the pathology report, defined as histologically negative resection margins. Final assessment will be made by the pathologist. |
| Technical success rate of intended drainage placement | During the endoscopic papillectomy procedure (Day 0), assessed immediately after attempted completion of the assigned drainage method | 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. |
| Incidence of hyperamylasemia | 6 hours, 24 hours, and 48 hours after endoscopic papillectomy. | 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). |
| Length of hospital stay | From admission to hospital discharge (up to 7 days) | 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. |
| En bloc resection rate | Immediately after lesion resection during the endoscopic papillectomy procedure (Day 0) | 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. |
| Incidence of postoperative complications | From completion of endoscopic papillectomy (Day 0) through postoperative day 30 (±7 days). | 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). |
| Duration of endoscopic papillectomy (EP) | During the endoscopic papillectomy procedure (Day 0), recorded immediately after procedure completion | 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 |
| Total hospitalization cost | From admission to hospital discharge (up to 7 days) | Total hospitalization cost will be obtained from the hospital billing system and recorded in Chinese Yuan (RMB) by the study coordinator. |
Contacts
CONTACTxiaobing cui
CONTACTkaiyun liu
Outcome results
None listed