Endoscopic Retrograde Cholangiopancreatography Access and Complication Rates After Cholecystectomy With Common Bile Duct Stones

NCT07640204 | Not Yet Recruiting

• 1 other identifier: 2026-02132-01
• Study Type: observational
• Target: 10,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this retrospective, register-based study is to investigate whether access, or no access, to endoscopic retrograde cholangiopancreatography (ERCP) at a surgical unit is associated with the risk of complications in patients undergoing laparoscopic cholecystectomy with common bile duct stones detected on intraoperative cholangiography.

Conditions

Common Bile Duct Stones

Keywords

Common bile duct stones; ERCP

Outcome Measures

Primary Outcomes (1)

• Complications

  Overall complications from both the cholecystectomy and the endoscopic retrograde cholangiopancreatography (ERCP).

  0- 30 days from the cholecystectomy, 0-30 days from any performed ERCP

Secondary Outcomes (5)

• Length of hospital stay

  0-100 days from the cholecystectomy, 0-100 days from any performed ERCP

• Time from cholecystectomy to first treatment of common bile duct stones

  0-100 days from the cholecystectomy

• Unplanned ERCP after surgery due to CBDS

  1-365 days

• Unplanned readmission

  0- 30 days from the cholecystectomy, 0-30 days from any performed ERCP

• Mortality

  0-30 days from the cholecystectomy, 0-30 days from any performed ERCP

Study Arms (2)

Cholecystectomy without access to endoscopic retrograde cholangiopancreatography (ERCP)

Patients, ≥18 years old, undergoing laparoscopic cholecystectomy with CBDS detected on IOC in Sweden 2015-2025 and registered in GallRiks. The cholecystectomy is performed in a unit without access to ERCP.

Other: Exposed group

Cholecystectomy with access to ERCP

Patients, ≥18 years old, undergoing laparoscopic cholecystectomy with CBDS detected on IOC in Sweden 2015-2025 and registered in GallRiks. The cholecystectomy is performed in a unit with access to ERCP.

Interventions

Exposed group OTHER

The exposed group consists of patients undergoing laparoscopic and diagnosed with CBDS during cholecystectomy at a unit where ERCP is not available.

Cholecystectomy without access to endoscopic retrograde cholangiopancreatography (ERCP)

Eligibility Criteria

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

Study Population

Patients, ≥18 years old, undergoing laparoscopic cholecystectomy with common bile duct stones detected on intraoperative cholangiography in Sweden 2015-2025 and registered in GallRiks.

You may qualify if:

• ≥18 years old
• Laparoscopic cholecystectomy with common bile duct stones (CBDS) detected on intraoperative cholangiography (IOC)
• Procedure registered in the Swedish Registry for Gallstone Surgery and ERCP (GallRiks) 2015-2025

You may not qualify if:

• Open surgery
• Conversion to open surgery
• Transgastric ERCP

Sponsors & Collaborators

• Karolinska Institutet: lead

Related Publications (8)

• Rystedt J, Montgomery A, Persson G. Completeness and correctness of cholecystectomy data in a national register--GallRiks. Scand J Surg. 2014 Dec;103(4):237-44. doi: 10.1177/1457496914523412. Epub 2014 Apr 15.

  PMID: 24737852 BACKGROUND

• Johansson S, Runfors C, Sandblom G, Lindkvist B, Thorell A, Reuterwall Hansson M. Laparoscopic transcystic stenting with postoperative ERCP for the treatment of common bile duct stones: a safe alternative to intraoperative rendezvous ERCP-Data from the Swedish registry for gallstone surgery and ERCP (GallRiks). Surg Endosc. 2026 Jan 21;40(4):3040-7. doi: 10.1007/s00464-026-12565-3. Online ahead of print.

  PMID: 41566062 BACKGROUND

• Syren EL, Sandblom G, Enochsson L, Eklund A, Isaksson B, Osterberg J, Eriksson S. Outcome of ERCP related to case-volume. Surg Endosc. 2022 Jul;36(7):5339-5347. doi: 10.1007/s00464-021-08915-y. Epub 2022 Jan 3.

  PMID: 34981237 BACKGROUND

• Swahn F, Nilsson M, Arnelo U, Lohr M, Persson G, Enochsson L. Rendezvous cannulation technique reduces post-ERCP pancreatitis: a prospective nationwide study of 12,718 ERCP procedures. Am J Gastroenterol. 2013 Apr;108(4):552-9. doi: 10.1038/ajg.2012.470. Epub 2013 Feb 19.

  PMID: 23419386 BACKGROUND

• Noel R, Arnelo U, Swahn F. Intraoperative versus postoperative rendezvous endoscopic retrograde cholangiopancreatography to treat common bile duct stones during cholecystectomy. Dig Endosc. 2019 Jan;31(1):69-76. doi: 10.1111/den.13222. Epub 2018 Jul 24.

  PMID: 29947437 BACKGROUND

• Moller M, Gustafsson U, Rasmussen F, Persson G, Thorell A. Natural course vs interventions to clear common bile duct stones: data from the Swedish Registry for Gallstone Surgery and Endoscopic Retrograde Cholangiopancreatography (GallRiks). JAMA Surg. 2014 Oct;149(10):1008-13. doi: 10.1001/jamasurg.2014.249.

  PMID: 25133326 BACKGROUND

• Tornqvist B, Stromberg C, Persson G, Nilsson M. Effect of intended intraoperative cholangiography and early detection of bile duct injury on survival after cholecystectomy: population based cohort study. BMJ. 2012 Oct 11;345:e6457. doi: 10.1136/bmj.e6457.

  PMID: 23060654 BACKGROUND

• Tornqvist B, Stromberg C, Akre O, Enochsson L, Nilsson M. Selective intraoperative cholangiography and risk of bile duct injury during cholecystectomy. Br J Surg. 2015 Jul;102(8):952-8. doi: 10.1002/bjs.9832. Epub 2015 Apr 28.

  PMID: 25919401 BACKGROUND

Central Study Contacts

Sara Johansson

CONTACT

+46727362315; snnsjohan@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator. MD, PhD

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): April 1, 2029
• Last Updated: June 10, 2026

Record last verified: 2026-06