Single Setting ERCP and Laparoscopic Cholecystectomy is a Safe Procedure in Patients With Cholecysto-Choledocholithiasis
Condition: Choledocholithiasis With Cholecystitis With Obstruction; Choledocholithiasis With Acute and Chronic Cholecystitis; Cholelithiasis With Acute and Chronic Cholecystitis
MeSH terms: Cholecystitis; Acalculous Cholecystitis; Cholelithiasis; Cholecystolithiasis; Gallstones; Choledocholithiasis; Cholecystitis, Acute
Study type: Observational

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.
    

Detailed 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.
    

Intervention name(s): ERCP+LC; OC+CBD
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients in this group underwent a single setting ERCP and Laparoscopic cholecystectomy.; Patients in this group underwent a single setting open cholecystectomy and open CBD exploration.
Observational model: Case-Control
Time perspective: Prospective
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.
      
Keywords: Common bile duct stones; Endoscopic Retrograde Cholangiopancreatography; Laparoscopic Cholecystectomy; Open Cholecystectomy