Post-Procedural ComplicationsNCT07891715
Biliary Plus Pancreatic Stent vs Pancreatic Stent Alone After Endoscopic Papillectomy
A study testing Endoscopic papillectomy with pancreatic duct stent placement and Endoscopic papillectomy with pancreatic duct and biliary stent placement in people with Post-Procedural Complications, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
This is a prospective, multicenter, open-label, randomized controlled trial designed to evaluate the safety and efficacy of biliary stent placement combined with pancreatic stent placement versus pancreatic stent alone in patients undergoing endoscopic papillectomy (EP) for duodenal ampullary adenoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Procedural Complications
- What is being tested?
- Endoscopic papillectomy with pancreatic duct stent placement and Endoscopic papillectomy with pancreatic duct and biliary stent placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2026to 20 Apr 2029
- Phase
- Interventional
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
- Age ≥18 years.
- Patients with histologically confirmed duodenal papillary adenoma or early-stage adenocarcinoma (≤T1a)
- Scheduled to undergo endoscopic papillectomy (EP).
- Patients confirmed by endoscopic ultrasound (EUS), magnetic resonance cholangiopancreatography (MRCP) or Intraductal ultrasound (IDUS )indicating no intraductal extension into the pancreatic or bile duct.
- Patients who provide written informed consent.
Who cannot join
- Contraindications to endoscopic procedures (e.g., severe esophageal stricture, inability to tolerate sedation).
- Ectopic duodenal papilla or congenital pancreaticobiliary developmental anomalies (e.g., pancreaticobiliary maljunction, pancreas divisum) .
- Pregnant or lactating women.
- Uncorrectable coagulopathy (INR > 1.5) or thrombocytopenia (platelet count < 50,000/μL), or inability to withhold antithrombotic (anticoagulant or antiplatelet) therapy for the planned endoscopic procedure.
- Major upper abdominal surgery or previous biliary surgery history.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Zhen Li, MD, 18560086106, qilulizhen@sdu.edu.cn
About this study
Official title: Biliary Stent Combined With Pancreatic Stent Versus Pancreatic Stent Alone in Endoscopic Papillectomy for Duodenal Ampullary Adenoma: A Multicenter, Randomized Controlled Trial
This is a prospective, multicenter, open-label, randomized controlled trial designed to evaluate the safety and efficacy of biliary stent placement combined with pancreatic stent placement versus pancreatic stent alone in patients undergoing endoscopic papillectomy (EP) for duodenal ampullary adenoma. The primary objective is to compare the overall incidence of post-procedural complications between the two groups. A total of 190 patients will be enrolled and randomized 1:1 to receive either pancreatic stent alone (PS group) or combined biliary and pancreatic stents (PBS group).
Read the detailed description
This is a multicenter, randomized, open-label, parallel-group trial comparing prophylactic biliary plus pancreatic duct stenting versus pancreatic duct stenting alone after endoscopic papillectomy for duodenal ampillary adenoma or early ampullary carcinoma (less than or equal to T1a). Patients are randomized 1:1. In both groups a pancreatic duct stent is placed at the end of the procedure; the experimental group additionally receives a biliary duct stent. Patients are followed up at 3, 6 and 12 months after the initial treatment and annually thereafter for at least 5 years, with side-viewing duodenoscopy, targeted biopsy of the scar and of any abnormal area.
- Conditions
- Post-Procedural Complications
- Being tested
- Endoscopic papillectomy with pancreatic duct stent placement, Endoscopic papillectomy with pancreatic duct and biliary stent placement
- Keywords
- endoscopic papillectomy, biliary stent, pancreatic stent, randomized controlled trial, Ampullary adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic papillectomy with pancreatic duct stent placementProcedure or surgery
Patients undergo standard EP for duodenal ampullary adenoma. A pancreatic duct stent is placed at the end of the procedure; no biliary stent is placed.
Endoscopic papillectomy with pancreatic duct and biliary stent placementProcedure or surgery
Patients undergo standard EP for duodenal ampullary adenoma. Both prophylactic pancreatic duct and biliary stents are placed at the end of the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic stent group | Active comparator | Patients undergoing EP followed by pancreatic duct stent placement only. Receives: Procedure: Endoscopic papillectomy with pancreatic duct stent placement |
| Combined Biliary and Pancreatic Stent | Experimental | Patients undergoing EP followed by pancreatic duct and biliary stent placement. Receives: Procedure: Endoscopic papillectomy with pancreatic duct and biliary stent placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall incidence of post-procedural complications
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.
Measured: Within 30 days after the initial treatment
Secondary outcomes (9)
Incidence of post-procedural pancreatitis
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.
Measured: Within 30 days after the initial treatment
Incidence of post-procedural bleeding
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.
Measured: Within 30 days after the initial treatment
Incidence of post-procedural perforation
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.
Measured: Within 30 days after the initial treatment
Incidence of post-procedural cholangitis
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.
Measured: Within 30 days after the initial treatment
Incidence of biliary stricture
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.
Measured: Within 12 months after the initial treatment
Incidence of transient adverse events (TAEs)
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).
Measured: Within 7 days after the initial treatment
Recurrence rate
Recurrence is defined as histologically confirmed ampullary adenoma growth at follow-up endoscopy more than 3 months after initial treatment.
Measured: At 12 months after the initial treatment
Residual rates
Residual is defined as histologically confirmed adenoma growth within 3 months after initial treatment.
Measured: Within 3 monthsafter the initial treatment
Length of hospital stay
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.
Measured: Within 12 months after the initial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start20 Oct 2026 (estimated)
- Primary completion20 Apr 2028 (estimated)
- Study completion20 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Post-Procedural ComplicationsStudies 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
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Friendship Hospital, LanZhou University, Shandong First Medical University, Sir Run Run Shaw Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, The First Affiliated Hospital of Nanchang University, Shandong Provincial Hospital, Sichuan Provincial People's Hospital
- Responsible party
- Sponsor
- Investigators
- Zhen Li, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891715
- Sponsor's protocol ID
- 2026SDU-QILU-5
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.
PubMed 20189503Kiriyama S, Kozaka K, Takada T, Strasberg SM, Pitt HA, Gabata T, Hata J, Liau KH, Miura F, Horiguchi A, Liu KH, Su CH, Wada K, Jagannath P, Itoi T, Gouma DJ, Mori Y, Mukai S, Gimenez ME, Huang WS, Kim MH, Okamoto K, Belli G, Dervenis C, Chan ACW, Lau WY, Endo I, Gomi H, Yoshida M, Mayumi T, Baron TH, de Santibanes E, Teoh AYB, Hwang TL, Ker CG, Chen MF, Han HS, Yoon YS, Choi IS, Yoon DS, Higuchi R, Kitano S, Inomata M, Deziel DJ, Jonas E, Hirata K, Sumiyama Y, Inui K, Yamamoto M. Tokyo Guidelines 2018: diagnostic criteria and severity grading of acute cholangitis (with videos). J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):17-30. doi: 10.1002/jhbp.512. Epub 2018 Jan 5.
PubMed 29032610Espinel J, Pinedo E, Ojeda V, Guerra Del Rio M. Endoscopic ampullectomy: a technical review. Rev Esp Enferm Dig. 2016 May;108(5):271-8. doi: 10.17235/reed.2016.3867/2015.
PubMed 27187501Li S, Wang Z, Cai F, Linghu E, Sun G, Wang X, Meng J, Du H, Yang Y, Li W. New experience of endoscopic papillectomy for ampullary neoplasms. Surg Endosc. 2019 Feb;33(2):612-619. doi: 10.1007/s00464-018-6577-2. Epub 2018 Nov 12.
PubMed 30421083Kang SH, Kim KH, Kim TN, Jung MK, Cho CM, Cho KB, Han JM, Kim HG, Kim HS. Therapeutic outcomes of endoscopic papillectomy for ampullary neoplasms: retrospective analysis of a multicenter study. BMC Gastroenterol. 2017 May 30;17(1):69. doi: 10.1186/s12876-017-0626-5.
PubMed 28558658Ito K, Fujita N, Noda Y, Kobayashi G, Obana T, Horaguchi J, Koshita S, Kanno Y, Ogawa T, Kato Y, Yamashita Y. Impact of technical modification of endoscopic papillectomy for ampullary neoplasm on the occurrence of complications. Dig Endosc. 2012 Jan;24(1):30-5. doi: 10.1111/j.1443-1661.2011.01161.x. Epub 2011 Jun 1.
PubMed 22211409Ru N, Chai N, Zhang B, Li L, Bi Y, Linghu E. Impact of pancreatic and biliary stent on post-endoscopic papillectomy complications: A single-center retrospective study. Chin Med J (Engl). 2024 Sep 5;137(17):2111-2118. doi: 10.1097/CM9.0000000000002893. Epub 2024 May 27.
PubMed 38809090Jiang L, Ling-Hu EQ, Chai NL, Li W, Cai FC, Li MY, Guo X, Meng JY, Wang XD, Tang P, Zhu J, Du H, Wang HB. Novel endoscopic papillectomy for reducing postoperative adverse events (with videos). World J Gastroenterol. 2020 Oct 28;26(40):6250-6259. doi: 10.3748/wjg.v26.i40.6250.
PubMed 33177797Fritzsche JA, Fockens P, Barthet M, Bruno MJ, Carr-Locke DL, Costamagna G, Cote GA, Deprez PH, Giovannini M, Haber GB, Hawes RH, Hyun JJ, Itoi T, Iwasaki E, Kylanpaa L, Neuhaus H, Park JY, Reddy DN, Sakai A, Bourke MJ, Voermans RP. Expert consensus on endoscopic papillectomy using a Delphi process. Gastrointest Endosc. 2021 Oct;94(4):760-773.e18. doi: 10.1016/j.gie.2021.04.009. Epub 2021 Apr 19.
PubMed 33887269Vanbiervliet G, Strijker M, Arvanitakis M, Aelvoet A, Arnelo U, Beyna T, Busch O, Deprez PH, Kunovsky L, Larghi A, Manes G, Moss A, Napoleon B, Nayar M, Perez-Cuadrado-Robles E, Seewald S, Barthet M, van Hooft JE. Endoscopic management of ampullary tumors: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2021 Apr;53(4):429-448. doi: 10.1055/a-1397-3198. Epub 2021 Mar 16.
PubMed 33728632