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

Choledocholithiasis With Acute and Chronic Cholecystitis Clinical Trial

Official title:

"Single Setting ERCP and Laparoscopic Cholecystectomy is a Safe Procedure in Patients With Cholecysto-Choledocholithiasis: A Prospective Study in a Peripheral-Level Hospital"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04213092
• Other study ID #: IRC-LMC 01-H-015
• Status: Completed
• Start date: November 2012
• Est. completion date: October 2015

Study information

• Verified date: December 2019
• Source: Lumbini Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This was a prospective study done on patients admitted for management of the cholecysto-choledocholithiasis in the Department of Surgery at the Lumbini Medical College and Teaching Hospital from November 2012 - October 2015. This is a peripheral setting hospital located in a remote city of Nepal-"Palpa". The study was approved by the institutional ethical committee- "IRC of Lumbini Medical College and Teaching Hospital" and written consent was obtained from all of the patients. A comprehensive literature search published in English was done till 2019 using Hinari, PubMed, Cochrane Library, EMBASE, Web of Science, and ScienceDirect.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 85 Years

Eligibility

Inclusion Criteria:

1. All the sonological proven cases of choledocholithiasis with cholelithiasis.

2. CBD diameter <2cm.

3. Age >13 yrs.

Exclusion Criteria:

1. Clinical, radiologic, or biochemical evidence of cholangitis and pancreatitis.

2. Evidence of cirrhosis, intrahepatic gallbladder, liver mass or abscess, neoplasm, Suppurative or necrotizing cholecystitis, gall bladder empyema, or perforation, Pregnancy.

Age >85 yrs.

Related Conditions & MeSH terms

• Cholecystitis
• Cholecystitis, Acute
• Cholecystolithiasis
• Choledocholithiasis
• Choledocholithiasis With Acute and Chronic Cholecystitis
• Choledocholithiasis With Cholecystitis With Obstruction
• Cholelithiasis
• Cholelithiasis With Acute and Chronic Cholecystitis
• Gallstones

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lumbini Medical College

References & Publications (11)

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. Review. — View Citation

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. Erratum in: Gastrointest Endosc. 2012 Jan;75(1):230-230.e14. — View Citation

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. — View Citation

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. — View Citation

Freitas ML, Bell RL, Duffy AJ. Choledocholithiasis: evolving standards for diagnosis and management. World J Gastroenterol. 2006 May 28;12(20):3162-7. Review. — View Citation

Gómez-Torres GA, González-Hernández J, López-Lizárraga CR, Navarro-Muñiz E, Ortega-García 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. — View Citation

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

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

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Morbidity	Detect cholangitis, pancreatitis, abdominal collection, and wound infection respectively	7 days
Secondary	Length	The length of Hospital stay	7 days