Effect of ECPP on Recurrent Bile Duct Stones

NCT05896280 | Unknown DMC

• 1 other identifier: LM2023425
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Endoscopic retrograde cholangiopancreatography (ERCP) combined with endoscopic papillary sphinctomy (EST) is the preferred clinical treatment for common bile duct stones, and this minimally invasive treatment technique has been widely used in clinical practice for decades. However, even after successful stone removal by EST combined with various methods, the incidence of postoperative recurrent bile duct stones can still be as high as 9.8%\~30% . The emergence of these long-term complications after EST surgery is currently thought to be related to the loss of Oddi sphincter function. In clinical practice, the investigators tried a new method to repair the Oddi sphincter, that is, after ERCP+EST stone removal, a metal clip was inserted into the endoscopic clamp through the duodenoscopy, and clamp precisely on both lateral edges of the nipple after incision. This procedure is called endoscopic nipple clipping (ECPP). Initial explorations in animal and human trials showed good results, with 3 weeks after clipping of the incised nipple not only showing scar repair of the nipple shape and structure, but also confirmed the recovery of sphincter function by Oddi sphincter manometry, the Oddi's sphincter basal pressure, contraction frequency and contraction amplitude were able to return to the pre-EST level. In summary, the investigators designed a single-center randomized controlled trial to explore and verify the clinical effect of ECPP on the prevention of recurrent bile duct stones within one year by comparing the incidence of recurrent bile duct stones within one year after EST surgery. By observing the changes of intestinal biliary reflux, biliary bacterial colonization, biliary microecology and bile metabolism after EST surgery, the pathogenesis of long-term complications such as recurrent bile duct stones after EST surgery was further sought.

Conditions

Sphincterotomy, Endoscopic

Outcome Measures

Primary Outcomes (1)

• Recurrent bile duct stones

  The patient developed a recurrence of common bile duct stones within 1 year after surgery. Signs of recurrent bile duct stones include symptoms of cholangitis such as abdominal pain, fever, jaundice, or re-elevation of direct bilirubin/GGT/ALP or simple imaging of common bile duct stones.

  12 months after ERCP

Secondary Outcomes (1)

• Death or adverse events

  12 months after ERCP

Study Arms (2)

EST in common bile duct stones

ACTIVE COMPARATOR

With routine EST surgery, the sphincter is cut open and stones are removed

Procedure: EST

ECPP in common bile duct stones

EXPERIMENTAL

Common bile duct stones are removed after EST, and then ECPP is performed.

Procedure: EST; Procedure: ECPP

Interventions

EST PROCEDURE

Stones are taken by cutting the papillary sphincter

ECPP in common bile duct stones; EST in common bile duct stones

ECPP PROCEDURE

During ERCP, a generous biliary sphincterotomy (\>1 cm) will be performed to facilitate large stone extraction by use of a lithotripsy basket and a stone extraction balloon. After all stone fragments were cleared from the bile duct, this group will undergo ECPP after EST. A single-pigtail biliary stent will be placed (suspended overlength biliary stent, 7F × 20 cm). Then the rotatable repeatable opening and closing of soft tissue clamps (referred to as harmony clips, Mico-Tech, ROCC-D-26-195) should be applied to extend the bile duct axially, linear clamp the incised duodenal papilla, taking care to avoid clamping the bile duct stent, and removing the bile duct stent 3 weeks after ECPP.

ECPP in common bile duct stones

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Imaging confirms the presence of common bile duct stones.
• Common bile duct stones ≥ 1.0 cm in length.
• Common bile duct inner diameter≥1.2cm.
• The patient agrees to participate in the trial and signs the informed consent form.

You may not qualify if:

• Combined with coagulation dysfunction.
• heart, lung, kidney or other serious organic diseases.
• Patients with severe psychiatric illness.
• Previous papillary sphincterotomy.
• Patients who cannot cooperate with the completion of this study.
• Those with a life expectancy of less than 1 year and may not be able to complete follow-up.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100101, China

RECRUITING

Related Publications (12)

• Kageoka M, Watanabe F, Maruyama Y, Nagata K, Ohata A, Noda Y, Miwa I, Ikeya K. Long-term prognosis of patients after endoscopic sphincterotomy for choledocholithiasis. Dig Endosc. 2009 Jul;21(3):170-5. doi: 10.1111/j.1443-1661.2009.00880.x.

  PMID: 19691764 BACKGROUND

• Nzenza TC, Al-Habbal Y, Guerra GR, Manolas S, Yong T, McQuillan T. Recurrent common bile duct stones as a late complication of endoscopic sphincterotomy. BMC Gastroenterol. 2018 Mar 15;18(1):39. doi: 10.1186/s12876-018-0765-3.

  PMID: 29544453 BACKGROUND

• Tanaka M, Takahata S, Konomi H, Matsunaga H, Yokohata K, Takeda T, Utsunomiya N, Ikeda S. Long-term consequence of endoscopic sphincterotomy for bile duct stones. Gastrointest Endosc. 1998 Nov;48(5):465-9. doi: 10.1016/s0016-5107(98)70086-0.

  PMID: 9831833 BACKGROUND

• Yang J, Jin H, Gu W, Zhang X, Zhang X. Determinants of long-term complications of endoscopic sphincterotomy are infections and high risk factors of bile duct and not sphincter of Oddi dysfunction. Eur J Gastroenterol Hepatol. 2015 Apr;27(4):412-8. doi: 10.1097/MEG.0000000000000295.

  PMID: 25874514 BACKGROUND

• Costamagna G, Tringali A, Shah SK, Mutignani M, Zuccala G, Perri V. Long-term follow-up of patients after endoscopic sphincterotomy for choledocholithiasis, and risk factors for recurrence. Endoscopy. 2002 Apr;34(4):273-9. doi: 10.1055/s-2002-23632.

  PMID: 11932781 BACKGROUND

• Sugiyama M, Atomi Y. Risk factors predictive of late complications after endoscopic sphincterotomy for bile duct stones: long-term (more than 10 years) follow-up study. Am J Gastroenterol. 2002 Nov;97(11):2763-7. doi: 10.1111/j.1572-0241.2002.07019.x.

  PMID: 12425545 BACKGROUND

• Mortensen FV, Jepsen P, Tarone RE, Funch-Jensen P, Jensen LS, Sorensen HT. Endoscopic sphincterotomy and long-term risk of cholangiocarcinoma: a population-based follow-up study. J Natl Cancer Inst. 2008 May 21;100(10):745-50. doi: 10.1093/jnci/djn102. Epub 2008 May 13.

  PMID: 18477806 BACKGROUND

• Stromberg C, Luo J, Enochsson L, Arnelo U, Nilsson M. Endoscopic sphincterotomy and risk of malignancy in the bile ducts, liver, and pancreas. Clin Gastroenterol Hepatol. 2008 Sep;6(9):1049-53. doi: 10.1016/j.cgh.2008.04.016. Epub 2008 Jun 30.

  PMID: 18585972 BACKGROUND

• Afghani E, Lo SK, Covington PS, Cash BD, Pandol SJ. Sphincter of Oddi Function and Risk Factors for Dysfunction. Front Nutr. 2017 Jan 30;4:1. doi: 10.3389/fnut.2017.00001. eCollection 2017.

  PMID: 28194398 BACKGROUND

• Mandryka Y, Klimczak J, Duszewski M, Kondras M, Modzelewski B. [Bile duct infections as a late complication after endoscopic sphincterotomy]. Pol Merkur Lekarski. 2006 Dec;21(126):525-7. Polish.

  PMID: 17405290 BACKGROUND

• Yasuda I, Fujita N, Maguchi H, Hasebe O, Igarashi Y, Murakami A, Mukai H, Fujii T, Yamao K, Maeshiro K, Tada T, Tsujino T, Komatsu Y. Long-term outcomes after endoscopic sphincterotomy versus endoscopic papillary balloon dilation for bile duct stones. Gastrointest Endosc. 2010 Dec;72(6):1185-91. doi: 10.1016/j.gie.2010.07.006. Epub 2010 Sep 25.

  PMID: 20869711 BACKGROUND

• Wang Y, Chang H, Zhang Y, Wang K, Zhang H, Yan X, Meng L, Yao W, Li K, Huang Y. Endoscopic endoclip papilloplasty preserves sphincter of oddi function. Eur J Clin Invest. 2021 Mar;51(3):e13408. doi: 10.1111/eci.13408. Epub 2020 Sep 22.

  PMID: 32929751 BACKGROUND

Study Officials

• Yonghui Huang, archiater

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yonghui Huang, archiater

CONTACT

13911765322; xuxiao_1028@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 9, 2023
• Study Start: December 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: December 31, 2023
• Last Updated: July 11, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)