Clinical trial NCT04213092: Single Setting ERCP and Laparoscopic Cholecystectomy is a Safe Procedure in Patients With Cholecysto-Choledocholithiasis
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"
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Lumbini Medical College
Sponsor class: OTHER
First posted: 2019-12-30
Enrollment: 160
Sex: ALL
Minimum age (years): 13
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Compare ERCP+LC with OC+CBD exploration
timeFrame: 7 days
Secondary outcomes:
measure: Morbidity
timeFrame: 7 days
measure: Length
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
affiliation: Lumbini Medical College & Teaching Hospital Ltd, Kathmandu University
name: Chet R Pant, MD, MPH
role: STUDY_CHAIR
References:
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