preGallstep - A Clinical Pilot Trial

NCT04801238 | Unknown DMC

• 1 other identifier: preGallstep
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

In Denmark, more than 7500 cholecystectomies are performed every year. Common bile duct gallstones (CBDS) are found in 3.4% to 18% of patients undergoing cholecystectomy. A two-step approach including endoscopic retrograde cholangiography (ERC) with stone extraction and papillotomy with subsequent laparoscopic cholecystectomy has become gold standard for treatment of CBDS in Denmark. However, ERC is associated with a high risk of complications and more than 50% of patients require multiple ERCs. Recent meta analyses find that a one-step approach might be superior in terms of safety, CBDS clearance rate, hospital stay, operative time, hospital cost and stone recurrence, but much more data is needed. The preGallstep trial is an investigator-initiated multicentre randomised clinical pilot trial with blinded outcome assessment investigating a novel one-step laparoscopic cholecystectomy with common bile duct exploration and stone extraction versus conventional two-step endoscopic retrograde cholangiography with stone extraction plus a subsequent laparoscopic cholecystectomy for patients with CBDS. After enrolment, the participant will be randomised to one of the two treatment approaches. Adult patients with imaging confirmed CBDS are eligible for inclusion. Potential postoperative complications will be assessed within 90 days following the procedure. The primary outcome is the proportion of serious adverse events (corresponding to a Clavien-Dindo score II or above) requiring re-intervention within 90 days of the initial procedure. This outcome will be used for a future sample size calculation. The sample size estimate, the inclusion rate and the estimated length of subsequent trial will be used to determine the feasibility of a large pragmatic and confirmatory trial. We hypothesize that the one-step approach will significantly reduce the risk of complications and number of treatments needed thereby making a difference to hundreds of people in Denmark each year.

Conditions

Pancreatitis; Cholangitis; Cholecystitis; Gallstone; Jaundice, Obstructive

Keywords

Obstructive Jaundice; gallbladder stones; common bile duct; ERC; LCBDE; Laparoscopic; Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Postoperative complications

  Proportion of participants with postoperative complications corresponding to a Clavien-Dindo score of 2-5

  90 days

Secondary Outcomes (10)

• Stone clearance failure

  perioperatively

• Number of procedures

  90 days after initial procedure

• Lenght of hospital stay

  90 days

• Stone size

  Perioperatively

• Number of stones

  perioperatively

Other Outcomes (1)

• Quality of Life survey

  90 days

Study Arms (2)

LCBDE + LC

ACTIVE COMPARATOR

Laparoscopic common bile duct exploration with laparoscopic cholecystectomy

Procedure: LCBDE + LC

ERC + LC

ACTIVE COMPARATOR

Endoscopic retrograde cholangiography with laparoscopic cholecystectomy

Procedure: ERC + LC

Interventions

LCBDE + LC PROCEDURE

Experimental group: Laparoscopic common bile duct exploration (LCBDE) + laparoscopic cholecystectomy (LC) is performed under full anaesthesia. Once the dissection has exposed the cystic a clip or ligature is placed peripherally on the cystic duct. Through an incision in the duct central to the clip or ligature a cholangiogram catheter is introduced into the cystic duct and the cholangiogram is completed. After identification of the bile duct stones and anatomy, a cholangioscope is introduced through the duct incision into common bile duct. The stones are identified visually and removed by Dormia basket. If the stones are very large, they may be partitioned mechanically or by electrohydraulic lithotripsy. In the presence of CBDS wedged in the papilla these stones will be removed and a secondary cholangiogram will be performed. Subsequently, the cholangioscope is taken out. Then the cystic duct is divided and the gallbladder is dissected out from the liver by hook cautery and removed.

LCBDE + LC

ERC + LC PROCEDURE

Control intervention: (First step) Endoscopic retrograde cholangiography (ERC) is routinely performed in sedation but or in full anaesthesia. ERC is performed with the patient in the supine position. The endoscope is passed down to the second part of the duodenum where the papilla is identified. Cannulation of the papilla and the common bile duct is performed with a papillotome and a guidewire. A cholangiography will confirm the presence, location and size of the CBDS and aims in further choice of extraction method. Stones can be extracted by papillotomy and by either balloon or by a basket. Additional balloon dilation of the papilla, or lithotripsy may be required. If stone extraction is incomplete or if the conditions are unclear a temporary common bile duct stent is placed which has to be removed with additional ERC after 1-2 months (Second step) laparoscopic cholecystectomy is performed after 2-14 days

ERC + LC

Eligibility Criteria

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

You may qualify if:

• Common bile duct stones identified by magnetic resonance cholangiopancreatography (MRCP).
• Age 18 years or older.
• Both interventions must be possible to perform within a clinically reasonable timeframe, as assessed by the investigator.
• Informed consent.

You may not qualify if:

• Patients with acute cholangitis corresponding to a grade III (elevated serum bilirubin, fever, and/or elevated white blood cell count and signs of severe organ failure) according to Tokyo guidelines 2018 including severe organ failure.
• Common bile duct cysts shown by magnetic resonance cholangiopancreatography (MRCP), ultrasonography, computer tomography (CT), or cholangiography.
• Pancreatic/biliary/hepatic malignancies.
• Prior cholecystectomy or sphincterotomy.
• Chronic pancreatitis.
• If assessed by investigator that laparoscopic cholecystectomy is not possible, e.g. due to prior surgery or patient condition.
• Gastric bypass.
• Pregnancy confirmed by elevated choriogonadotropin (hCG) in women below 60 years.
• No informed consent.

Sponsors & Collaborators

• Lars Tue Sorensen: lead
• Copenhagen Trial Unit, Center for Clinical Intervention Research: collaborator

Study Sites (1)

Digestive disease center, Bispebjerg Hospital

Copenhagen NV, Not in US/Canada, 2400, Denmark

RECRUITING

Related Publications (41)

• Ryberg AA, Fitzgibbons RJ Jr, Tseng A, Maffi TR, Burr LJ, Doris PE. Abnormal cholangiograms during laparoscopic cholecystectomy. Is treatment always necessary? Surg Endosc. 1997 May;11(5):456-9. doi: 10.1007/s004649900389.

  PMID: 9153174 BACKGROUND

• Sarli L, Pietra N, Franze A, Colla G, Costi R, Gobbi S, Trivelli M. Routine intravenous cholangiography, selective ERCP, and endoscopic treatment of bile duct stones before laparoscopic cholecystectomy. Gastrointest Endosc. 1999 Aug;50(2):200-8. doi: 10.1016/s0016-5107(99)70225-7.

  PMID: 10425413 BACKGROUND

• Collins C, Maguire D, Ireland A, Fitzgerald E, O'Sullivan GC. A prospective study of common bile duct calculi in patients undergoing laparoscopic cholecystectomy: natural history of choledocholithiasis revisited. Ann Surg. 2004 Jan;239(1):28-33. doi: 10.1097/01.sla.0000103069.00170.9c.

  PMID: 14685097 BACKGROUND

• Balandraud P, Biance N, Peycru T, Tardat E, Bonnet PM, Cazeres C, Hardwigsen J. Fortuitous discovery of common bile duct stones: results of a conservative strategy. Gastroenterol Clin Biol. 2008 Apr;32(4):408-12. doi: 10.1016/j.gcb.2008.02.023. Epub 2008 Apr 9.

  PMID: 18403152 BACKGROUND

• Hammarstrom LE, Holmin T, Stridbeck H, Ihse I. Long-term follow-up of a prospective randomized study of endoscopic versus surgical treatment of bile duct calculi in patients with gallbladder in situ. Br J Surg. 1995 Nov;82(11):1516-21. doi: 10.1002/bjs.1800821121.

  PMID: 8535807 BACKGROUND

• Targarona EM, Ayuso RM, Bordas JM, Ros E, Pros I, Martinez J, Teres J, Trias M. Randomised trial of endoscopic sphincterotomy with gallbladder left in situ versus open surgery for common bileduct calculi in high-risk patients. Lancet. 1996 Apr 6;347(9006):926-9. doi: 10.1016/s0140-6736(96)91413-0.

  PMID: 8598755 BACKGROUND

• Boerma D, Rauws EA, Keulemans YC, Janssen IM, Bolwerk CJ, Timmer R, Boerma EJ, Obertop H, Huibregtse K, Gouma DJ. Wait-and-see policy or laparoscopic cholecystectomy after endoscopic sphincterotomy for bile-duct stones: a randomised trial. Lancet. 2002 Sep 7;360(9335):761-5. doi: 10.1016/S0140-6736(02)09896-3.

  PMID: 12241833 BACKGROUND

• Frossard JL, Hadengue A, Amouyal G, Choury A, Marty O, Giostra E, Sivignon F, Sosa L, Amouyal P. Choledocholithiasis: a prospective study of spontaneous common bile duct stone migration. Gastrointest Endosc. 2000 Feb;51(2):175-9. doi: 10.1016/s0016-5107(00)70414-7.

  PMID: 10650260 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

• Coelho-Prabhu N, Shah ND, Van Houten H, Kamath PS, Baron TH. Endoscopic retrograde cholangiopancreatography: utilisation and outcomes in a 10-year population-based cohort. BMJ Open. 2013 May 31;3(5):e002689. doi: 10.1136/bmjopen-2013-002689.

  PMID: 23793659 BACKGROUND

• Horiuchi A, Nakayama Y, Kajiyama M, Kato N, Kamijima T, Graham DY, Tanaka N. Biliary stenting in the management of large or multiple common bile duct stones. Gastrointest Endosc. 2010 Jun;71(7):1200-1203.e2. doi: 10.1016/j.gie.2009.12.055. Epub 2010 Apr 18.

  PMID: 20400079 BACKGROUND

• Ding X, Zhang F, Wang Y. Risk factors for post-ERCP pancreatitis: A systematic review and meta-analysis. Surgeon. 2015 Aug;13(4):218-29. doi: 10.1016/j.surge.2014.11.005. Epub 2014 Dec 24.

  PMID: 25547802 BACKGROUND

• Castoldi L, De Rai P, Zerbi A, Frulloni L, Uomo G, Gabbrielli A, Bassi C, Pezzilli R; ProInf-AISP (Progetto Informatizzato Pancreatite Acuta, Associazione Italiana per lo Studio del Pancreas) Study Group. Long term outcome of acute pancreatitis in Italy: results of a multicentre study. Dig Liver Dis. 2013 Oct;45(10):827-32. doi: 10.1016/j.dld.2013.03.012. Epub 2013 Jul 3.

  PMID: 23831129 BACKGROUND

• Das SL, Singh PP, Phillips AR, Murphy R, Windsor JA, Petrov MS. Newly diagnosed diabetes mellitus after acute pancreatitis: a systematic review and meta-analysis. Gut. 2014 May;63(5):818-31. doi: 10.1136/gutjnl-2013-305062. Epub 2013 Aug 8.

  PMID: 23929695 BACKGROUND

• Petrov MS, Shanbhag S, Chakraborty M, Phillips AR, Windsor JA. Organ failure and infection of pancreatic necrosis as determinants of mortality in patients with acute pancreatitis. Gastroenterology. 2010 Sep;139(3):813-20. doi: 10.1053/j.gastro.2010.06.010. Epub 2010 Jun 9.

  PMID: 20540942 BACKGROUND

• Pendharkar SA, Salt K, Plank LD, Windsor JA, Petrov MS. Quality of life after acute pancreatitis: a systematic review and meta-analysis. Pancreas. 2014 Nov;43(8):1194-200. doi: 10.1097/MPA.0000000000000189.

  PMID: 25333403 BACKGROUND

• Frimberger E. Long-term sequelae of endoscopic papillotomy. Endoscopy. 1998 Nov;30(9):A221-7. doi: 10.1055/s-2007-1001444. No abstract available.

  PMID: 9932785 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

• Hakamada K, Sasaki M, Endoh M, Itoh T, Morita T, Konn M. Late development of bile duct cancer after sphincteroplasty: a ten- to twenty-two-year follow-up study. Surgery. 1997 May;121(5):488-92. doi: 10.1016/s0039-6060(97)90101-x.

  PMID: 9142145 BACKGROUND

• Thorlund K, Devereaux PJ, Wetterslev J, Guyatt G, Ioannidis JP, Thabane L, Gluud LL, Als-Nielsen B, Gluud C. Can trial sequential monitoring boundaries reduce spurious inferences from meta-analyses? Int J Epidemiol. 2009 Feb;38(1):276-86. doi: 10.1093/ije/dyn179. Epub 2008 Sep 29.

  PMID: 18824467 BACKGROUND

• Wetterslev J, Jakobsen JC, Gluud C. Trial Sequential Analysis in systematic reviews with meta-analysis. BMC Med Res Methodol. 2017 Mar 6;17(1):39. doi: 10.1186/s12874-017-0315-7.

  PMID: 28264661 BACKGROUND

• Wetterslev J, Thorlund K, Brok J, Gluud C. Estimating required information size by quantifying diversity in random-effects model meta-analyses. BMC Med Res Methodol. 2009 Dec 30;9:86. doi: 10.1186/1471-2288-9-86.

  PMID: 20042080 BACKGROUND

• Jarvinen TL, Sihvonen R, Bhandari M, Sprague S, Malmivaara A, Paavola M, Schunemann HJ, Guyatt GH. Blinded interpretation of study results can feasibly and effectively diminish interpretation bias. J Clin Epidemiol. 2014 Jul;67(7):769-72. doi: 10.1016/j.jclinepi.2013.11.011. Epub 2014 Feb 20.

  PMID: 24560088 BACKGROUND

• Miura F, Okamoto K, Takada T, Strasberg SM, Asbun HJ, Pitt HA, Gomi H, Solomkin JS, Schlossberg D, Han HS, Kim MH, Hwang TL, Chen MF, Huang WS, Kiriyama S, Itoi T, Garden OJ, Liau KH, Horiguchi A, Liu KH, Su CH, Gouma DJ, Belli G, Dervenis C, Jagannath P, Chan ACW, Lau WY, Endo I, Suzuki K, Yoon YS, de Santibanes E, Gimenez ME, Jonas E, Singh H, Honda G, Asai K, Mori Y, Wada K, Higuchi R, Watanabe M, Rikiyama T, Sata N, Kano N, Umezawa A, Mukai S, Tokumura H, Hata J, Kozaka K, Iwashita Y, Hibi T, Yokoe M, Kimura T, Kitano S, Inomata M, Hirata K, Sumiyama Y, Inui K, Yamamoto M. Tokyo Guidelines 2018: initial management of acute biliary infection and flowchart for acute cholangitis. J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):31-40. doi: 10.1002/jhbp.509. Epub 2018 Jan 8.

  PMID: 28941329 BACKGROUND

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

• ASGE Standards of Practice Committee; Buxbaum JL, Abbas Fehmi SM, Sultan S, Fishman DS, Qumseya BJ, Cortessis VK, Schilperoort H, Kysh L, Matsuoka L, Yachimski P, Agrawal D, Gurudu SR, Jamil LH, Jue TL, Khashab MA, Law JK, Lee JK, Naveed M, Sawhney MS, Thosani N, Yang J, Wani SB. ASGE guideline on the role of endoscopy in the evaluation and management of choledocholithiasis. Gastrointest Endosc. 2019 Jun;89(6):1075-1105.e15. doi: 10.1016/j.gie.2018.10.001. Epub 2019 Apr 9.

  PMID: 30979521 BACKGROUND

• Dasari BV, Tan CJ, Gurusamy KS, Martin DJ, Kirk G, McKie L, Diamond T, Taylor MA. Surgical versus endoscopic treatment of bile duct stones. Cochrane Database Syst Rev. 2013 Dec 12;2013(12):CD003327. doi: 10.1002/14651858.CD003327.pub4.

  PMID: 24338858 RESULT

• Cuschieri A, Lezoche E, Morino M, Croce E, Lacy A, Toouli J, Faggioni A, Ribeiro VM, Jakimowicz J, Visa J, Hanna GB. E.A.E.S. multicenter prospective randomized trial comparing two-stage vs single-stage management of patients with gallstone disease and ductal calculi. Surg Endosc. 1999 Oct;13(10):952-7. doi: 10.1007/s004649901145.

  PMID: 10526025 RESULT

• Noble H, Tranter S, Chesworth T, Norton S, Thompson M. A randomized, clinical trial to compare endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy with primary laparoscopic bile duct exploration during cholecystectomy in higher risk patients with choledocholithiasis. J Laparoendosc Adv Surg Tech A. 2009 Dec;19(6):713-20. doi: 10.1089/lap.2008.0428.

  PMID: 19792866 RESULT

• Bansal VK, Misra MC, Rajan K, Kilambi R, Kumar S, Krishna A, Kumar A, Pandav CS, Subramaniam R, Arora MK, Garg PK. Single-stage laparoscopic common bile duct exploration and cholecystectomy versus two-stage endoscopic stone extraction followed by laparoscopic cholecystectomy for patients with concomitant gallbladder stones and common bile duct stones: a randomized controlled trial. Surg Endosc. 2014 Mar;28(3):875-85. doi: 10.1007/s00464-013-3237-4. Epub 2013 Oct 26.

  PMID: 24162138 RESULT

• Ding G, Cai W, Qin M. Single-stage vs. two-stage management for concomitant gallstones and common bile duct stones: a prospective randomized trial with long-term follow-up. J Gastrointest Surg. 2014 May;18(5):947-51. doi: 10.1007/s11605-014-2467-7. Epub 2014 Feb 4.

  PMID: 24493296 RESULT

• Lv F, Zhang S, Ji M, Wang Y, Li P, Han W. Single-stage management with combined tri-endoscopic approach for concomitant cholecystolithiasis and choledocholithiasis. Surg Endosc. 2016 Dec;30(12):5615-5620. doi: 10.1007/s00464-016-4918-6. Epub 2016 Apr 28.

  PMID: 27126621 RESULT

• Koc B, Karahan S, Adas G, Tutal F, Guven H, Ozsoy A. Comparison of laparoscopic common bile duct exploration and endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy for choledocholithiasis: a prospective randomized study. Am J Surg. 2013 Oct;206(4):457-63. doi: 10.1016/j.amjsurg.2013.02.004. Epub 2013 Jul 17.

  PMID: 23871320 RESULT

• Sgourakis G, Karaliotas K. Laparoscopic common bile duct exploration and cholecystectomy versus endoscopic stone extraction and laparoscopic cholecystectomy for choledocholithiasis. A prospective randomized study. Minerva Chir. 2002 Aug;57(4):467-74.

  PMID: 12145577 RESULT

• Bansal VK, Misra MC, Garg P, Prabhu M. A prospective randomized trial comparing two-stage versus single-stage management of patients with gallstone disease and common bile duct stones. Surg Endosc. 2010 Aug;24(8):1986-9. doi: 10.1007/s00464-010-0891-7. Epub 2010 Feb 5.

  PMID: 20135172 RESULT

• Rogers SJ, Cello JP, Horn JK, Siperstein AE, Schecter WP, Campbell AR, Mackersie RC, Rodas A, Kreuwel HT, Harris HW. Prospective randomized trial of LC+LCBDE vs ERCP/S+LC for common bile duct stone disease. Arch Surg. 2010 Jan;145(1):28-33. doi: 10.1001/archsurg.2009.226.

  PMID: 20083751 RESULT

• Pan L, Chen M, Ji L, Zheng L, Yan P, Fang J, Zhang B, Cai X. The Safety and Efficacy of Laparoscopic Common Bile Duct Exploration Combined with Cholecystectomy for the Management of Cholecysto-choledocholithiasis: An Up-to-date Meta-analysis. Ann Surg. 2018 Aug;268(2):247-253. doi: 10.1097/SLA.0000000000002731.

  PMID: 29533266 RESULT

• Singh AN, Kilambi R. Single-stage laparoscopic common bile duct exploration and cholecystectomy versus two-stage endoscopic stone extraction followed by laparoscopic cholecystectomy for patients with gallbladder stones with common bile duct stones: systematic review and meta-analysis of randomized trials with trial sequential analysis. Surg Endosc. 2018 Sep;32(9):3763-3776. doi: 10.1007/s00464-018-6170-8. Epub 2018 Mar 30.

  PMID: 29603004 RESULT

• Ricci C, Pagano N, Taffurelli G, Pacilio CA, Migliori M, Bazzoli F, Casadei R, Minni F. Comparison of Efficacy and Safety of 4 Combinations of Laparoscopic and Intraoperative Techniques for Management of Gallstone Disease With Biliary Duct Calculi: A Systematic Review and Network Meta-analysis. JAMA Surg. 2018 Jul 18;153(7):e181167. doi: 10.1001/jamasurg.2018.1167. Epub 2018 Jul 18.

  PMID: 29847616 RESULT

• Barreras Gonzalez JE, Torres Pena R, Ruiz Torres J, Martinez Alfonso MA, Brizuela Quintanilla R, Morera Perez M. Endoscopic versus laparoscopic treatment for choledocholithiasis: a prospective randomized controlled trial. Endosc Int Open. 2016 Nov;4(11):E1188-E1193. doi: 10.1055/s-0042-116144.

  PMID: 27857966 RESULT

• Kirkegaard-Klitbo A, Shabanzadeh DM, Olsen MH, Lindschou J, Gluud C, Sorensen LT. One-step laparoscopic cholecystectomy with common bile duct exploration and stone extraction versus two-step endoscopic retrograde cholangiography with stone extraction plus laparoscopic cholecystectomy for patients with common bile duct stones: a randomised feasibility and pilot clinical trial-the preGallStep trial. Pilot Feasibility Stud. 2023 Feb 6;9(1):21. doi: 10.1186/s40814-023-01251-z.

  PMID: 36740708 DERIVED

Related Links

• Danish health authorities guidelines
• Online only article

MeSH Terms

Conditions

Pancreatitis; Cholangitis; Cholecystitis; Gallstones; Jaundice, Obstructive; Cholecystolithiasis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Bile Duct Diseases; Biliary Tract Diseases; Gallbladder Diseases; Cholelithiasis; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Jaundice; Hyperbilirubinemia; Pathologic Processes; Skin Manifestations; Signs and Symptoms

Central Study Contacts

Anders Kirkegaard-klitbo, MD

CONTACT

+4520713638; anders.kirkegaard-Klitbo@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The obvious advantages of a one-step procedure compared with a two-step procedure are the fewer surgical procedures required to clear CBDS and to remove the gallbladder. Due to the nature of the surgical interventions, blinding of patients or physicians is not possible for this trial. Most of the outcomes are dependent on the physician's clinical assessment. However, we will engage a blinded adjudication committee of 3 independent experts who will examine medical charts from randomisation to 90-day follow-up for outcome assessment. Photocopies of the medical charts will have intervention blinded. Also photocopies or print outs of medical charts will be changed so that follow up interventions will become blinded for initial intervention in both intervention groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Surgical Department

Model Details: The preGallStep is an investigator-initiated, multicentre randomised parallel group, clinical pilot trial, with blinded outcome assessment investigating one-step laparoscopic cholecystectomy with common bile duct exploration and stone extraction versus two-step endoscopic retrograde cholangiography with stone extraction plus laparoscopic cholecystectomy for patients with common bile duct stones.

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 16, 2021
• Study Start: April 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: March 1, 2024
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After publication

Locations

DK (1)