Single Setting ERCP and Laparoscopic Cholecystectomy is a Safe Procedure in Patients With Cholecysto-Choledocholithiasis

NCT04213092 | Completed

• 1 other identifier: IRC-LMC 01-H-015
• Study Type: observational
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

The ideal management of cholecysto-choledocholithiasis is an open cholecystectomy (OC) with the common bile duct (CBD) exploration worldwide. The single setting 2-stage approach- endoscopic retrograde cholangiopancreatography (ERCP), endoscopic sphincterotomy (EST), and CBD clearance followed by laparoscopic cholecystectomy (LC) offers an advantage, mainly by reducing the hospital stay, the cost, and the morbidity. Investigators did a prospective study in patients admitted for the management of the cholecysto-choledocholithiasis in the Department of Surgery at the Lumbini Medical College and Teaching Hospital from November 2012- October 2015. They underwent 2-stage ERCP+LC in a single setting and investigators compared them with 2-stage OC+CBD exploration in a single setting approach. The patients with the open procedure were the investigator's control groups. All the included cases in the study were elective.

Conditions

Choledocholithiasis With Cholecystitis With Obstruction; Choledocholithiasis With Acute and Chronic Cholecystitis; Cholelithiasis With Acute and Chronic Cholecystitis

Keywords

Common bile duct stones; Endoscopic Retrograde Cholangiopancreatography; Laparoscopic Cholecystectomy; Open Cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Compare ERCP+LC with OC+CBD exploration

  To compare the single setting ERCP+LC with OC+CBD exploration and the Feasibility of the procedure at the peripheral setting hospital.

  7 days

Secondary Outcomes (2)

• Morbidity

  7 days

• Length

  7 days

Study Arms (2)

ERCP+LC

Patients in this group underwent 2-stage ERCP+LC in a single setting. And, it was compared with our control group

Procedure: ERCP+LC

OC+CBD

This group with 2-stage OC+CBD exploration in a single setting approach was taken as a control group.

Procedure: OC+CBD

Interventions

ERCP+LC PROCEDURE

Patients in this group underwent a single setting ERCP and Laparoscopic cholecystectomy.

ERCP+LC

OC+CBD PROCEDURE

Patients in this group underwent a single setting open cholecystectomy and open CBD exploration.

OC+CBD

Eligibility Criteria

• Age: 13 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study was carried out in a peripheral setting hospital located in a remote city of Nepal-"Palpa" and the population is heterogeneous in terms of age.

You may qualify if:

• All the sonological proven cases of choledocholithiasis with cholelithiasis.
• CBD diameter \<2cm.
• Age \>13 yrs.

You may not qualify if:

• Clinical, radiologic, or biochemical evidence of cholangitis and pancreatitis.
• Evidence of cirrhosis, intrahepatic gallbladder, liver mass or abscess, neoplasm, Suppurative or necrotizing cholecystitis, gall bladder empyema, or perforation, Pregnancy.
• Age \>85 yrs.

Sponsors & Collaborators

• Lumbini Medical College: lead

Related Publications (11)

• European Association for the Study of the Liver (EASL). Electronic address: easloffice@easloffice.eu. EASL Clinical Practice Guidelines on the prevention, diagnosis and treatment of gallstones. J Hepatol. 2016 Jul;65(1):146-181. doi: 10.1016/j.jhep.2016.03.005. Epub 2016 Apr 13. No abstract available.

  PMID: 27085810 BACKGROUND

• Zhu HY, Xu M, Shen HJ, Yang C, Li F, Li KW, Shi WJ, Ji F. A meta-analysis of single-stage versus two-stage management for concomitant gallstones and common bile duct stones. Clin Res Hepatol Gastroenterol. 2015 Oct;39(5):584-93. doi: 10.1016/j.clinre.2015.02.002. Epub 2015 Apr 27.

  PMID: 25936687 BACKGROUND

• ASGE Standards of Practice Committee; Maple JT, Ikenberry SO, Anderson MA, Appalaneni V, Decker GA, Early D, Evans JA, Fanelli RD, Fisher D, Fisher L, Fukami N, Hwang JH, Jain R, Jue T, Khan K, Krinsky ML, Malpas P, Ben-Menachem T, Sharaf RN, Dominitz JA. The role of endoscopy in the management of choledocholithiasis. Gastrointest Endosc. 2011 Oct;74(4):731-44. doi: 10.1016/j.gie.2011.04.012. No abstract available.

  PMID: 21951472 BACKGROUND

• Gurusamy KS, Giljaca V, Takwoingi Y, Higgie D, Poropat G, Stimac D, Davidson BR. Ultrasound versus liver function tests for diagnosis of common bile duct stones. Cochrane Database Syst Rev. 2015 Feb 26;2015(2):CD011548. doi: 10.1002/14651858.CD011548.

  PMID: 25719223 BACKGROUND

• Miletic D, Uravic M, Mazur-Brbac M, Stimac D, Petranovic D, Sestan B. Role of magnetic resonance cholangiography in the diagnosis of bile duct lithiasis. World J Surg. 2006 Sep;30(9):1705-12. doi: 10.1007/s00268-005-0459-1.

  PMID: 16850153 BACKGROUND

• Freitas ML, Bell RL, Duffy AJ. Choledocholithiasis: evolving standards for diagnosis and management. World J Gastroenterol. 2006 May 28;12(20):3162-7. doi: 10.3748/wjg.v12.i20.3162.

  PMID: 16718834 BACKGROUND

• Lee A, Min SK, Park JJ, Lee HK. Laparoscopic common bile duct exploration for elderly patients: as a first treatment strategy for common bile duct stones. J Korean Surg Soc. 2011 Aug;81(2):128-33. doi: 10.4174/jkss.2011.81.2.128. Epub 2011 Aug 3.

  PMID: 22066112 BACKGROUND

• Gurusamy KS, Giljaca V, Takwoingi Y, Higgie D, Poropat G, Stimac D, Davidson BR. Endoscopic retrograde cholangiopancreatography versus intraoperative cholangiography for diagnosis of common bile duct stones. Cochrane Database Syst Rev. 2015 Feb 26;2015(2):CD010339. doi: 10.1002/14651858.CD010339.pub2.

  PMID: 25719222 BACKGROUND

• Gomez-Torres GA, Gonzalez-Hernandez J, Lopez-Lizarraga CR, Navarro-Muniz E, Ortega-Garcia OS, Bonnet-Lemus FM, Abarca-Rendon FM, De la Cerda-Trujillo LF. Intraoperative cholangiography versus magnetic resonance cholangiography in patients with mild acute biliary pancreatitis: A prospective study in a second-level hospital. Medicine (Baltimore). 2018 Nov;97(44):e12976. doi: 10.1097/MD.0000000000012976.

  PMID: 30383648 BACKGROUND

• Alexakis N, Connor S. Meta-analysis of one- vs. two-stage laparoscopic/endoscopic management of common bile duct stones. HPB (Oxford). 2012 Apr;14(4):254-9. doi: 10.1111/j.1477-2574.2012.00439.x. Epub 2012 Feb 3.

  PMID: 22404264 BACKGROUND

• ElGeidie AA, ElShobary MM, Naeem YM. Laparoscopic exploration versus intraoperative endoscopic sphincterotomy for common bile duct stones: a prospective randomized trial. Dig Surg. 2011;28(5-6):424-31. doi: 10.1159/000331470. Epub 2012 Jan 7.

  PMID: 22236538 BACKGROUND

Study Officials

• Chet R Pant, MD, MPH

  Lumbini Medical College & Teaching Hospital Ltd, Kathmandu University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass. Prof. Dr Nabin Pokharel

Study Record Dates

• First Submitted: December 25, 2019
• First Posted: December 30, 2019
• Study Start: November 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available for all interested researchers via the publication.
• Access Criteria: interested researchers in the field of ERCP; Laparoscopic Cholecystectomy; Open Cholecystectomy, Laparoscopic CBD Exploration, Open CBD Exploration.