Diagnostic and Therapeutic Impact of Spyglass DS-Assisted Single-Operator Digital Cholangioscopy During ERCP

Öz

Aim: This study aimed to evaluate the technical success, diagnostic and therapeutic impact, safety profile, and long-term outcomes of SpyGlass DS-assisted single-operator digital cholangioscopy performed concomitantly with endoscopic retrograde cholangiopancreatography (ERCP). Methods: A retrospective analysis of 55 consecutive adult patients who underwent SpyGlass DS-assisted cholangioscopy during ERCP at a tertiary referral center between February 2022 and May 2024 was performed. Technical success, additional diagnostic findings, therapeutic outcomes, complications, and long-term outcomes were assessed. Results: Cholangioscopy was technically successful in 49 of 55 patients (89.1%). The most common indication was choledocholithiasis (78.2%), followed by evaluation of indeterminate biliary strictures, intraoperative/perioperative biliary assessment, and management of migrated stents. Among the 49 technically successful procedures, cholangioscopy revealed additional clinically relevant findings that altered patient management in 10 patients (20.4%). In five patients (10.2%), residual stones were detected despite negative balloon occlusion cholangiography during ERCP. In two patients (4.0%), intraductal lesions that could not be adequately characterized by fluoroscopic methods were visualized. In three patients, intraoperative or perioperative cholangioscopy contributed directly to surgical decision-making. Post-ERCP pancreatitis occurred in 5 patients (9.1%), all mild. During a mean follow-up of 30 months, 4 patients (7.3%) required repeat biliary intervention. Conclusions: SpyGlass DS-assisted digital cholangioscopy is a valuable adjunct to conventional ERCP, providing a high technical success rate and clinically meaningful diagnostic information beyond that obtained with standard imaging. Its ability to detect residual stones and characterize intraductal lesions may influence patient management, while selected intraoperative applications suggest a promising role in hepatobiliary surgery.

Anahtar Kelimeler

• Cholangioscopy
• SpyGlass DS
• ERCP
• choledocholithiasis
• biliary stricture
• single-operator cholangioscopy

ERCP ile Eş Zamanlı SpyGlass DS Tek Operatörlü Dijital Kolanjioskopi: Tanısal ve Terapötik Sonuçların Değerlendirilmesi

Öz

Amaç: Bu çalışmanın amacı, ERCP ile eş zamanlı uygulanan SpyGlass DS destekli tek operatörlü dijital kolanjioskopinin teknik başarısını, tanısal ve terapötik katkılarını, güvenlik profilini ve uzun dönem klinik sonuçlarını değerlendirmektir. Yöntem: Şubat 2022–Mayıs 2024 tarihleri arasında üçüncü basamak bir referans merkezinde ERCP ile eş zamanlı SpyGlass DS kolanjioskopi uygulanan 55 ardışık erişkin hasta retrospektif olarak incelendi. Teknik başarı, ek tanısal katkı, terapötik girişim başarısı, komplikasyonlar ve uzun dönem takip sonuçları değerlendirildi. Bulgular: Kolanjioskopi 55 hastanın 49’unda (%89.1) teknik olarak başarıyla gerçekleştirildi. En sık endikasyon koledokolitiazis (%78.2) olup, belirsiz biliyer darlık değerlendirilmesi, intraoperatif/perioperatif biliyer değerlendirme ve migre stent yönetimi diğer endikasyonları oluşturdu. Kolanjioskopinin teknik olarak başarılı olduğu 49 hastanın 9’unda (%18.4), konvansiyonel yöntemlerle saptanamayan ve klinik yönetimi değiştiren ek bulgular ortaya konuldu. Beş hastada (%10.2), negatif balon oklüzyon kolanjiografisine rağmen rezidü taş saptandı. Üç hastada intraoperatif veya perioperatif dönemde kolanjioskopi kullanılarak cerrahi karar verme sürecine katkı sağlandı. Post-ERCP pankreatit 5 hastada (%9.1) gelişti ve tüm olgular hafif şiddette seyretti. Takip sürecinde 5 hastada (%9.1) kolesistit gelişti. Ortalama 30 aylık takip süresinde 4 hastada (%7.3) yeniden biliyer girişim gereksinimi ortaya çıktı. Sonuç: SpyGlass DS destekli dijital kolanjioskopi, yüksek teknik başarı oranı ve özellikle konvansiyonel yöntemlerle saptanamayan klinik açıdan anlamlı bulguların ortaya konulmasına sağladığı katkı ile pankreatikobiliyer hastalıkların yönetiminde değerli bir tamamlayıcı yöntemdir. Seçilmiş intraoperatif olgularda hepatobiliyer cerrahi ile entegrasyonu da umut verici sonuçlar ortaya koymaktadır.

Anahtar Kelimeler

• Kolanjioskopi
• SpyGlass DS
• ERCP
• koledokolitiazis
• biliyer darlık
• tek operatörlü kolanjioskopi

Kaynakça

1. Sejpal D, Trindade A, Lee C, Miller L, Benias P, Inamdar S, et al. Digital cholangioscopy can detect residual biliary stones missed by occlusion cholangiogram in ERCP: a prospective tandem study. Endosc Int Open. 2019 Apr 12;07(04):E608–14. doi:10.1055/a-0842-6450
2. Dall’Agnol MK, Boghossian MB, Ardengh AO, Fernandes YR, Veras M de O, dos Santos ESV, et al. Peroral cholangioscopy for detecting residual stones missed by cholangiography: Systematic review and meta-analysis. Endosc Int Open. 2025 Aug 4;13(CP). doi:10.1055/a-2676-4062
3. Zhou B, Zhao L, Xing X, Wang H, Kuwantai A, Chen K. Risk factors for postretrograde cholangiopancreatography pancreatitis in patients with common bile duct stones: A metaanalysis. Exp Ther Med. 2023 Nov 24;27(1):32. doi:10.3892/etm.2023.12320
4. Facciorusso A, Crinò SF, Gkolfakis P, Spadaccini M, Arvanitakis M, Beyna T, et al. Diagnostic work-up of bile duct strictures: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2025 Feb 17;57(02):166–85. doi:10.1055/a-2481-7048
5. Wen LJ, Chen JH, Xu HJ, Yu Q, Liu K. Efficacy and Safety of Digital Single-Operator Cholangioscopy in the Diagnosis of Indeterminate Biliary Strictures by Targeted Biopsies: A Systematic Review and Meta-Analysis. Diagnostics. 2020 Sep 2;10(9):666. doi:10.3390/diagnostics10090666
6. Rey Rubiano AM, González-Teshima LY, Arango L, Blanco-Avellaneda C, Carvajal Gutiérrez JJ, Castaño-Llano R, et al. Clinical practice guideline on the use of single-operator cholangioscopy in the diagnosis of indeterminate biliary stricture and the treatment of difficult biliary stones. Surg Endosc. 2024 Feb 26;38(2):499–510. doi:10.1007/s00464-023-10569-x
7. Chen YK, Parsi MA, Binmoeller KF, Hawes RH, Pleskow DK, Slivka A, et al. Single-operator cholangioscopy in patients requiring evaluation of bile duct disease or therapy of biliary stones (with videos). Gastrointest Endosc. 2011 Oct;74(4):805–14. doi:10.1016/j.gie.2011.04.016
8. Gopakumar H, Sharma NR. Role of peroral cholangioscopy and pancreatoscopy in the diagnosis and treatment of biliary and pancreatic disease: past, present, and future. Frontiers in Gastroenterology. 2023 Oct 3;2. doi:10.3389/fgstr.2023.1201045

9. Chen YK. Preclinical characterization of the Spyglass peroral cholangiopancreatoscopy system for direct access, visualization, and biopsy. Gastrointest Endosc. 2007 Feb;65(2):303–11. doi:10.1016/j.gie.2006.07.048
10. Navaneethan U, Hasan MK, Kommaraju K, Zhu X, Hebert-Magee S, Hawes RH, et al. Digital, single-operator cholangiopancreatoscopy in the diagnosis and management of pancreatobiliary disorders: a multicenter clinical experience (with video). Gastrointest Endosc. 2016 Oct;84(4):649–55. doi:10.1016/j.gie.2016.03.789
11. Tejido C, Puga M, Regueiro C, Francisco M, Rivas L, Sánchez E. Evaluation of the effectiveness and safety of single-operator cholangiopancreatoscopy with the SpyGlassTM system. Gastroenterología y Hepatología (English Edition). 2024 Feb;47(2):170–8. doi:10.1016/j.gastre.2023.06.002
12. Brewer Gutierrez OI, Bekkali NLH, Raijman I, Sturgess R, Sejpal D V., Aridi HD, et al. Efficacy and Safety of Digital Single-Operator Cholangioscopy for Difficult Biliary Stones. Clinical Gastroenterology and Hepatology. 2018 Jun;16(6):918-926.e1. doi:10.1016/j.cgh.2017.10.017
13. Buxbaum J, Sahakian A, Ko C, Jayaram P, Lane C, Yu CY, et al. Randomized trial of cholangioscopy-guided laser lithotripsy versus conventional therapy for large bile duct stones (with videos). Gastrointest Endosc. 2018 Apr;87(4):1050–60. doi:10.1016/j.gie.2017.08.021
14. Fugazzola P, Bianchi CM, Calabretto F, Cicuttin E, Dal Mas F, Dominioni T, et al. Intraoperative transcystic laparoscopic common bile duct stone clearance with SpyGlassTM discover during emergency and elective cholecystectomy: a single-center case series. World Journal of Emergency Surgery. 2024 Mar 4;19(1):8. doi:10.1186/s13017-023-00529-0
15. Abdelkader A, Basu S, Khalid AUA, Siddique J, Luqhman A, Naveed W, et al. Laparoscopic Transcystic SpyGlass Discover-Assisted Common Bile Duct Exploration and Clearance: An Efficient and Cost-Effective Alternative for Common Bile Duct Stone Management. Cureus. 2025 Mar 11. doi:10.7759/cureus.80398
16. Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RCG, Meyers WC, et al. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991 May;37(3):383–93. doi:10.1016/S0016-5107(91)70740-2
17. Satava RM. Identification and reduction of surgical error using simulation. Minimally Invasive Therapy & Allied Technologies. 2005 Jan 10;14(4–5):257–61. doi:10.1080/13645700500274112
18. Lenze F, Bokemeyer A, Gross D, Nowacki T, Bettenworth D, Ullerich H. Safety, diagnostic accuracy and therapeutic efficacy of digital single‐operator cholangioscopy. United European Gastroenterol J. 2018 Jul;6(6):902–9. doi:10.1177/2050640618764943
19. Korrapati P, Ciolino J, Wani S, Shah J, Watson R, Muthusamy V, et al. The efficacy of peroral cholangioscopy for difficult bile duct stones and indeterminate strictures: a systematic review and meta-analysis. Endosc Int Open. 2016 Feb 4;04(03):E263–75. doi:10.1055/s-0042-100194
20. Fujii-Lau LL, Thosani NC, Al-Haddad M, Acoba J, Wray CJ, Zvavanjanja R, et al. American Society for Gastrointestinal Endoscopy guideline on the role of endoscopy in the diagnosis of malignancy in biliary strictures of undetermined etiology: summary and recommendations. Gastrointest Endosc. 2023 Nov;98(5):685–93. doi:10.1016/j.gie.2023.06.005
21. Elmunzer BJ, Maranki JL, Gómez V, Tavakkoli A, Sauer BG, Limketkai BN, et al. ACG Clinical Guideline: Diagnosis and Management of Biliary Strictures. American Journal of Gastroenterology. 2023 Mar;118(3):405–26. doi:10.14309/ajg.0000000000002190
22. de Oliveira PVAG, de Moura DTH, Ribeiro IB, Bazarbashi AN, Franzini TAP, dos Santos MEL, et al. Efficacy of digital single-operator cholangioscopy in the visual interpretation of indeterminate biliary strictures: a systematic review and meta-analysis. Surg Endosc. 2020 Aug 27;34(8):3321–9. doi:10.1007/s00464-020-07583-8
23. Chandrasekhara V, Khashab MA, Muthusamy VR, Acosta RD, Agrawal D, Bruining DH, et al. Adverse events associated with ERCP. Gastrointest Endosc. 2017 Jan;85(1):32–47. doi:10.1016/j.gie.2016.06.051
24. Bishay K, Meng ZW, Khan R, Gupta M, Ruan Y, Vaska M, et al. Adverse Events Associated With Endoscopic Retrograde Cholangiopancreatography: Systematic Review and Meta-Analysis. Gastroenterology. 2025 Mar;168(3):568–86. doi:10.1053/j.gastro.2024.10.033
25. Beran A, Aboursheid T, Ali AH, Nayfeh T, Albunni H, Vargas A, et al. Predictors of Post-endoscopic Retrograde Cholangiopancreatography Pancreatitis: A Comprehensive Systematic Review and Meta-analysis. Clinical Gastroenterology and Hepatology. 2025 Oct;23(11):1905–16. doi:10.1016/j.cgh.2024.11.014