NCT07891715

Brief 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. 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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
30mo left

Started Oct 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

October 20, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 23, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2029

Last Updated

October 23, 2026

Status Verified

October 1, 2026

Enrollment Period

1.5 years

First QC Date

October 18, 2026

Last Update Submit

October 18, 2026

Conditions

Post-Procedural Complications

Keywords

endoscopic papillectomybiliary stentpancreatic stentrandomized controlled trialAmpullary adenoma

Outcome Measures

Primary Outcomes (1)

  • 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.

    Within 30 days after the initial treatment

Secondary Outcomes (9)

  • Incidence of post-procedural pancreatitis

    Within 30 days after the initial treatment

  • Incidence of post-procedural bleeding

    Within 30 days after the initial treatment

  • Incidence of post-procedural perforation

    Within 30 days after the initial treatment

  • Incidence of post-procedural cholangitis

    Within 30 days after the initial treatment

  • Incidence of biliary stricture

    Within 12 months after the initial treatment

  • +4 more secondary outcomes

Study Arms (2)

Pancreatic stent group

ACTIVE COMPARATOR

Patients undergoing EP followed by pancreatic duct stent placement only.

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.

Procedure: Endoscopic papillectomy with pancreatic duct and biliary stent placement

Interventions

Endoscopic papillectomy with pancreatic duct stent placementPROCEDURE

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.

Pancreatic stent group
Endoscopic papillectomy with pancreatic duct and biliary stent placementPROCEDURE

Patients undergo standard EP for duodenal ampullary adenoma. Both prophylactic pancreatic duct and biliary stents are placed at the end of the procedure.

Combined Biliary and Pancreatic Stent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

Related Publications (10)

  • 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.

    PMID: 20189503BACKGROUND

  • Kiriyama 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.

    PMID: 29032610BACKGROUND

  • Espinel 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.

    PMID: 27187501BACKGROUND

  • Li 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.

    PMID: 30421083BACKGROUND

  • Kang 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.

    PMID: 28558658BACKGROUND

  • Ito 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.

    PMID: 22211409BACKGROUND

  • Ru 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.

    PMID: 38809090BACKGROUND

  • Jiang 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.

    PMID: 33177797BACKGROUND

  • Fritzsche 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.

    PMID: 33887269BACKGROUND

  • Vanbiervliet 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.

    PMID: 33728632BACKGROUND

Study Officials

  • Zhen Li

    Qilu Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhen Li, MD

CONTACT

18560086106qilulizhen@sdu.edu.cn

Ning Zhong, MD

CONTACT

18560086096zhongning@email.sdu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2026

First Posted

October 23, 2026

Study Start

October 20, 2026

Primary Completion (Estimated)

April 20, 2028

Study Completion (Estimated)

April 20, 2029

Last Updated

October 23, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)