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"
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.
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.
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