Single Setting ERCP and Laparoscopic Cholecystectomy is a Safe Procedure in Patients With Cholecysto-Choledocholithiasis
NCT ID: NCT04213092
Last Updated: 2020-01-02
Study Results
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Basic Information
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COMPLETED
160 participants
OBSERVATIONAL
2012-11-30
2015-10-31
Brief Summary
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Detailed Description
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This is an interim analysis of 160 patients with 83 (51.9%) patients in ERCP+LC and 77 (48.1%) in open procedure (OC with CBD exploration) group respectively. The primary objective was to compare the single setting ERCP+LC with OC+CBD exploration and the secondary objectives were to study 1) the feasibility of the procedure, 2) detect the morbidity (cholangitis, pancreatitis, abdominal collection, and wound infection), 3) the length of stay, and ). The stone clearance respectively. The investigators defined their single-setting procedure as ERCP followed by LC. The patients from an open procedure group were those who underwent the procedure before our team was trained to carry out the ERCP. This open procedure group also included 10 patients who underwent open surgery due to unsuccessful ERCP. And finally, investigators compared ERCP+LC group with those who underwent the open procedure. The inclusion and exclusion criteria for ERCP+LC and open procedure are shown in Table 1 and Table 2 respectively.
After being informed about the related therapeutic maneuver, the patients were chosen for the sequence of endoscopic procedures and LC. And, the unsuccessful patients underwent through the OC with CBD exploration along with choledochoscopy. General anesthesia with nasal endotracheal intubation was done in all the patients. Antibiotic prophylaxis was given according to the standard recommendation for cholecystectomy.18 The ERCP procedure was performed with the patients in the prone position. A duodenoscope (TJF160R, Fujinon, Japan) was inserted into the second segment of duodenum via the mouth. A cholangiogram was carried out using C-arm X-ray (SIEMENS) and an EST was performed to extract the CBD stones. The stones were removed by basket or balloon catheter. Stones larger than 10 mm were removed using a mechanical lithotripter. Following ERCP, care was taken to remove all the gas from the stomach to facilitate LC. The patients were then placed in the reverse Trendelenburg position. LC was performed using the four trocar technique. A sub-hepatic drain was positioned if there was any concern about the possible bile leakage or bleeding in the postoperative period.
In cases of failed ERCP, the patients were placed in the supine position and OC with CBD explorations were performed in the same setting. A right subcostal incision was given for the open surgery. Cholecystectomy was performed ante-grade or retro-grade technique depending upon the anatomical variations of the gallbladder. CBD was opened below the opening of the cystic duct and stone clearances were done. To assure the stone clearances intraoperative choledochoscopies were performed. All the procedure viz. ERCP, LC, and open surgeries were performed by an experienced single surgeon and his team.
The statistical data were analyzed with a t-test, Pearson's χ2, Fisher's exact test, Mann Whitney's test, and Kruskal Wallis test using a statistical analysis program (SPSS 16), p \<0.05 was considered statistically significant.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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ERCP+LC
Patients in this group underwent 2-stage ERCP+LC in a single setting. And, it was compared with our control group
ERCP+LC
Patients in this group underwent a single setting ERCP and Laparoscopic cholecystectomy.
OC+CBD
This group with 2-stage OC+CBD exploration in a single setting approach was taken as a control group.
OC+CBD
Patients in this group underwent a single setting open cholecystectomy and open CBD exploration.
Interventions
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ERCP+LC
Patients in this group underwent a single setting ERCP and Laparoscopic cholecystectomy.
OC+CBD
Patients in this group underwent a single setting open cholecystectomy and open CBD exploration.
Eligibility Criteria
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Inclusion Criteria
2. CBD diameter \<2cm.
3. Age \>13 yrs.
Exclusion Criteria
2. Evidence of cirrhosis, intrahepatic gallbladder, liver mass or abscess, neoplasm, Suppurative or necrotizing cholecystitis, gall bladder empyema, or perforation, Pregnancy.
Age \>85 yrs.
13 Years
85 Years
ALL
No
Sponsors
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Lumbini Medical College
OTHER
Responsible Party
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NabinPokharel
Ass. Prof. Dr Nabin Pokharel
Principal Investigators
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Chet R Pant, MD, MPH
Role: STUDY_CHAIR
Lumbini Medical College & Teaching Hospital Ltd, Kathmandu University
References
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European Association for the Study of the Liver (EASL). Electronic address: [email protected]. 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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IRC-LMC 01-H-015
Identifier Type: -
Identifier Source: org_study_id
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