Endoscopic Common Bile Duct Stones Clearance During Pregnancy: Challenges and solutions. A retrospective Cohort Study

doi:10.21203/rs.3.rs-3782624/v1

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Endoscopic Common Bile Duct Stones Clearance During Pregnancy: Challenges and solutions. A retrospective Cohort Study

https://doi.org/10.21203/rs.3.rs-3782624/v1

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Background

Pregnancy is associated with a higher risk of common bile duct stones. Currently Endoscopic Retrograde Cholangiopancreatography (ERCP) is the treatment of choice for symptomatic choledocholithiasis. However, ERCP during pregnancy is associated with hazards of radiation exposure, as well as challenging patient positioning and anesthesia.

Aim of the study:

It aimed to present our trial to overcome challenges in endoscopic clearance of symptomatic common bile duct stones during pregnancy.

Patients and methods:

This is a retrospective analysis of endoscopic CBD clearance in 27 pregnant patients with symptomatic choledocholithiasis between February 2019 and February 2023. Sedation and anesthesia was done by safe medications by senior anesthetist, and the endoscopic procedure was performed in left lateral decubitus instead of prone position. The gravid uterus was kept away from the monopolar electrocautery current pathway. Radiocontrast injection and fluoroscopy was deleted and replaced by trans-abdominal US and endoscopic bile aspiration. Data were collected, tabulated and analyzed by SPSS ver. 26.

Result

The patient’s age ranged from 18 to 36 years (Mean: 25 years). The mean duration of gestation ranged from 7–32 (Mean 15 weeks) and 17 patients were in the first trimester, 8 patients in the second trimester, and two patients in the third trimester). Therapeutic ERCP was successfully performed in all patients. The time of the procedure ranged from 19 to 45 minutes (Mean: 27 ± 13 min). As regards post-ERCP complications, one patient (3.7%) developed pancreatitis post-ERCP and was treated successfully with conservative treatment, and one patient (3.7%) with minor bleeding. All procedures were performed without any material adverse events immediately or on follow-up. There were no signs of fetal distress during any of these cases, and there were no fetal complications noted upon delivery or at 30-day follow-up.

Conclusion

Endoscopic clearance of symptomatic common bile duct stones during pregnancy can be obtained safely without fluoroscopy. Adjunct US and endoscopic bile aspiration can overcome the absence of fluoroscopy. Careful positioning of the patient, proper positioning of monopolar cautery pad, and judicious anesthetic modification are all crucial for patient and fetal safety.

Non-Radiation

ERCP

Pregnancy

Guide Wire Cannulation

Choledocholithiasis

Pregnancy is associated with an increased frequency of gallstones and its related complications. Hormonal changes during pregnancy are known to predispose to biliary disease and promote cholelithiasis. The incidence of gallstone disease during pregnancy has been reported as 3.2– 12.2% of all pregnancies [1, 2]. This risk is increased with each pregnancy, and multiparous women are 10 times more likely to develop biliary complications [3]. Symptomatic choledocholithiasis occurs in less than 10% of the symptomatic patients [5]. Common bile duct stones are a serious complication of gallstones, which can lead to gallstone pancreatitis, cholangitis, sepsis, and even fetal and maternal death that require urgent therapeutic intervention [6].

ERCP has been the standard minimally invasive technique and procedure of choice in the treatment of common bile duct stones [7]. Besides the usual risks associated with ERCP, it also is associated with ionizing radiation that might carry teratogenic risks to the fetus and hazards in pregnancy. Also, risks are not limited to exposure to radiation, but also medication teratogenicity, anesthesia, and the risk of pancreatitis is higher in pregnant patients (16%) compared to non-pregnant patients [8, 9].

As regards radiation, it might cause fetal anomalies and preterm labor, particularly when ERCP is performed in the first trimester [9]. Therefore, many groups have advocated for the complete exclusion of radiation to decrease fetal risk by using non-radiation ERCP (NR-ERCP).

Since non-radiation ERCP during pregnancy was first reported in 1990, it has been shown that ERCP can be carried out safely without necessitating fluoroscopic use [10].

The primary goal of NR-ERCP is to achieve biliary cannulation without radiation exposure, either empirical guide-wire cannulation or with imaging tools (such as ultrasound or choledochoscopy) guidance [11]. Excluding fluoroscopy had many drawbacks as failed cannulation or incomplete bile duct cannulation and the possibility of failing to remove all biliary stones or sludge [12].

There are limited studies published in the literature regarding the efficacy of abdominal ultrasound (US) as an adjunct to endoscopy to ensure successful canulation of the guide wire to CBD. Most of the data are from case reports and small series. Many researchers have reported their experiences using endoscopic biliary stenting, without fluoroscopy nor imaging guidance.

In this study, we retrospectively present our trial to overcome challenges during endoscopic clearance of symptomatic common bile duct stones during pregnancy.

In the current study, the authors retrospectively analyzed data of pregnant women, presented with symptomatic common bile duct stones in a tertiary care hospital, between February 2019 and February 2023. Approval of the study was obtained from the local institutional ethical committee. This work has been reported in line with the STROCSS criteria [13].

The extracted data included gestational age, clinical presentations, and routine laboratory examinations, including Serum bilirubin level, alkaline phosphatase, liver enzymes, coagulation profile, and white blood cell count before and 24 hours after the intervention.

The data also included the results of abdominal US examination, the diameter of CBD, the number and size of CBD stones, the presence or absence of intra-hepatic biliary dilation, a magnetic resonance cholangiopancreatography (MRCP) was performed to confirm the presence of stones in the CBD if an abdominal ultrasonography examination revealed gallbladder stones and suspicion of CBD stones. We excluded from the study patients with biliary obstruction due to malignant cause and patients with acute pancreatitis. This study was approved by the local ethics committee.

Methods:

After an explanation of the risks, complications, and alternatives of the endoscopic procedure. A formal written consent form was obtained from all of the studied patients. The patients were assessed by an obstetrician for fetal well-being and by an anesthesiologist in terms of fitness for general anesthesia and endotracheal intubation. The patients were fast for approximately 8 hours before the procedure. A prophylactic antibiotic was administered. The procedure was performed under general anesthesia with cuffed endotracheal intubation in left lateral decubitus.

The anesthesia was carried out by a senior anesthetist. Medications was calculated as follows: Propofol 1.5 mg /kg, Atracium 0.5mg/kg for induction of anesthesia then 0.1 mg /kg for maintenance. Cuffed endotracheal tube was inserted, then isoflurane was used for maintenance of anesthesia. Reversal was done through neostigmine 50 µ gram /kg plus atropine 0.02mg/kg and Extubating after full awakening of the patient. Pethidine 25mg was given. With intraoperative monitoring, noninvasive BP, ECG, and capnography.

Endoscopic procedure was carried out by duodenoscope with side viewing. (Olympus side-viewing endoscopes TJF- 160VR are employed). after the advancement of the duodenoscope into the duodenum, the papilla was localized and cannulated with a standard hydrophilic guide wire (280 cm, 0.035”; Cook Medical Inc., Winston-Salem, USA). After CBD cannulation, we confirmed a successful common bile duct cannulation by aspiration of bile and abdominal US (Fig. 1). Endoscopic sphincterotomy was carried out by bipolar current when required to facilitate extraction of stones by balloon and Dormia basket, and successful clearance was confirmed by the US (Fig. 2), if suspicious was present, a stent was introduced under sonographic guidance (Fig. 3), plastic stents (10-French, 10 cm; Cook Medical, Winston-Salem, USA) were used with good bile flow.

In case of non-visualization of the wire by the US, another trial of wire manipulation was carried out to ensure the proper wire position inside the CBD using the least invasive technique. The procedure time was calculated from introduction of duodenoscope from mouth until removal of it.

Follow up:

The follow-up serum amylase and lipase levels were measured 24 hours after the procedure. Endoscopic complications, including bleeding, perforation, pancreatitis, fever, cholangitis, or evidence of fetal compromise, were assessed. Fetal complications were also assessed before discharge, at delivery, and one month after delivery.

The patient’s age ranged from 18–36 years (Mean: 25 years). The mean duration of gestation ranged from 7–32 (Mean 15 weeks) and 17 patients were in the first trimester, 8 patients in the second trimester, and two patients in the third trimester). Seventeen women were in their first pregnancy; the other ten women were in their second pregnancy. Before the procedure, choledocholithiasis was identified in radiologic studies in all patients (22 patients with abdominal US, 5 patients with MRCP). 15 patients with single stones, 5 patients with two stones, and 7 patients had multiple CBD stones. The maximum stone diameter ranged from 4–12 mm. All patients had dilated CBD, with the diameter ranging from 7–14 mm. Elevated liver enzymes in various degrees were noted in all patients (Table 1). Three patients had acute cholecystitis clinically, and one patient had acute cholangitis.

Table 1

Demographic and Preoperative Data of Pregnant Women Included in the Study.
Parameters	Values mean
Maternal age (in years)	18–36 Mean (25)
Gestational age (in weeks)	7–32 Mean (15)
Clinical presentations: − Jaundice − Right upper quadrant pain − Fever	27 patients 27 patients 4 patients
Laboratory data: − Total bilirubin (mg/dL) − Direct bilirubin (mg/dL) − AST − ALT − Alkaline phosphatase (IU/dl) − Total leukocyte count (cells/mm) − Amylase (U/L)	2.5 to 8.9 mg/dL (mean: 5.2 mg/dL) 2.3 to 7.5 mg/dL (mean: 3.2 mg/Dl) 54–967 U/L (mean: 250 U/L) 55–910 U/L (mean: 115 U/L) 404.6 ± 424.6 7.2 (4–15.4) 23–150 U/L (mean: 69 U/L)
Ultrasound and MRCP findings: − Single CBD stone − Two stones − Multiple CBD stones − Diameter CBD (mm)	15 patients (55.5%) 5 patients (18.5%) 7 patients (25.9%) 7–14 mm (average 11 mm)

All the patients had jaundice; most of them were presented with right upper quadrant pain (biliary colic) and three patients had fever. The total serum bilirubin ranged from 2.5 to 8.9 mg/dL (Mean: 5.2 mg/dL); the direct serum bilirubin level ranged from 2,3 to 7.5 mg/dL (Mean: 3.2 mg/dL); the ALT level ranged from 54–967 U/L (Mean: 250 U/L); the AST level ranged from 55–910 U/L (Mean: 115 U/L); and the serum amylase level ranged from 23–150 U/L (Mean: 69 U/L) (Table 1).

As regards the endoscopic technique, successful biliary cannulation was achieved by sphincterotome in 22 patients by precut in 5 patients. Stones extracted by balloon in 13 patients and by Dormia basket in 8 patients. Extraction was failed in two patients, but no stones were extracted in four patients although MRCP confirmed the presence of stone and most probably spontaneously passed, and we inserted a biliary stent in 6 patients ((22.22%) (two patients with failed clearance and 4 patients we did not find any stone most probably passed stone.

Selective cannulation of CBD was successful in all cases and confirmed by an abdominal US scan of CBD to visualize the wire. After the extraction of stones, the free bile flow was immediately achieved. The time of the procedure ranged from 19–45 minutes (Mean: 27 ± 13 min). This relatively long time due to the time needed for abdominal US in every case to confirm successful cannulation and clearance.

As regards complications, There was one patient (3.7%) developed pancreatitis and was treated successfully with conservative treatment and one patient (3.7%) with minor bleeding was treated by washing with epinephrine and the bleeding stopped (Table 2).

Table 2

Endoscopic findings, outcomes, and complications.
Outcomes	Values
Successful papilla cannulation: − Sphincterotomy − Precut	27 patients (100%) 22 patients (81.5%) 5 patients (18.5%)
Successful wire placement in the CBD Extraction by balloon Extraction by Dormia basket Failed clearance Passed stones (clear CBD) Successful stent placement	27 patients (100%) 13 patients (48.14%) 8 patients (29.62%) 2 patients (7.4%) 4 patients (14,8%) 6 patients (22.22%)
Operative time (min): − Range − Mean	19–45 minutes 27 ± 13 min
Clinical success/Resolution of symptoms:	27 patients (100%)
Postoperative complications: − Acute pancreatitis − Minor bleeding − Acute cholangitis − Perforation − Obstetric/fetal complications 0/10	One patient (3.7%) One patient (3.7%) 0/27 patients 0/27 patients 0/27 patients

Biliary colic, abdominal pain, jaundice, and fever were markedly improved in the majority of the patients. Total bilirubin levels became normal after a median of 8 days (range 5–15 days). All patients were discharged from the hospital within 24 hours, except one patient who developed pancreatitis and was discharged after 5 days after improvement of the pain of pancreatitis and obstetrician consultation.

No maternal and fetal adverse events or complications were determined after the procedures or on follow-up period. The course of pregnancy was, in each case, entirely normal with the delivery of a healthy child at term. None of the patients had symptoms of choledocholithiasis and/or cholangitis during follow-up period.

Biliary disease is considered the second most common gastrointestinal disorder that requires surgery during pregnancy after appendicitis [14]. Migration of gall stones to the common bile duct may cause various complications such as cholangitis and biliary pancreatitis which are life-threatening for both the mother and the fetus [15]. ERCP is currently the standard technique for treating symptomatic common bile duct stones during pregnancy, but it has many hazards as radiation exposure and sedation and procedural medications may be harmful to the fetus and pregnant women as it may induce fetal teratogenicity and premature labor and abortion [16].

Several studies have confirmed the safety and efficacy of ERCP in pregnancy [16–19]. We can minimize radiation exposure by using external shielding of the fetus with a lead placed under the pelvis and lower abdomen, to limit fluoroscopy time, reduce overall radiation exposure, and avoid taking hard copy X-ray films. With these precautions, fetal exposure was estimated to be well below the level to trigger radiation-induced teratogenesis [17–20].

We can also avoid radiation risks by deleting fluoroscopy. ERCP without fluoroscopy during pregnancy was first described in 1990. A needle-knife sphincterotomy was performed to free an impacted stone at the ampulla of Vater [21]. Since then, a few case reports and a small case series of radiation-free ERCP in pregnant women have been reported. Non-Radiation-ERCP technique can be classified into empirical bile aspiration and ultrasonic guidance cannulation. Bile duct cannulation was confirmed by bile aspiration or visualization of bile around the guidewire [11, 22]. The main disadvantage of this technique is bile aspiration cannot differentiate between biliary and cystic duct cannulation, and the stent might be inserted into the gallbladder [15].

US was used to confirm guide wire bile duct cannulation, the correct positioning of a papillotomy device and is useful to identify the position of a CBD stone and proves the clearance of stones within the common bile duct, and insertion of biliary stent under US guidance and prove that stent in normal position [23–24]. US-guided endoscopic biliary stenting has been only recently reported by Sharma and Maharshi who described a two-step procedure, using biliary sphincterotomy and stenting without fluoroscopy [24].

There are some drawbacks of US guidance, after sphincterotomy or balloon dilatation of the duodenal papilla, air flows into the bile ducts and obscures the ultrasonographic view of the biliary system. Irrigation with saline into the common bile duct can expel a portion of the air, but it is still hard to obtain a satisfactory image of the bile ducts. Also, changing position to supine position is required for satisfactory US examination [26].

As regards the position of patients, ERCP in non-pregnant patients is usually performed with the patient in the prone position to aid in selective bile cannulation and to provide better fluoroscopic imaging compared to other positions. However, this position is not safe during advanced pregnancy (second and third trimester) for many reasons: to avoid patient discomfort from the enlarged, gravid uterus pressing against the hard X-ray platform, to avoid decreased systemic and uterine perfusion from the enlarged gravid uterus compressing the aorta, and to avoid decreased venous return from the enlarged gravid uterus compressing the inferior vena cava [26]. Also regarding sphincterotomy, it is best done by bipolar diathermy as the American Society for Gastrointestinal Endoscopy guidelines recommend to use of bipolar cautery [27], but if it is not present we could use monopolar electrocautery, but we must put a return electrode (cautery pad) on the trunk or upper abdomen. This is to ensure that the uterus is not between the active and return electrodes to avoid fetal effects as amniotic fluid can conduct electrical current to the fetus, [28–29].

In the current study, we presented one of the largest series of pregnant patients who underwent non-radiation ERCP because of symptomatic choledocholithiasis in various trimesters under trans-abdominal US guidance. Biliary cannulation we cannulated the bile duct with the assistance of a guidewire. Cannulation was confirmed by bile aspiration and/or visualization of the bile oozing around the guidewire after cannulation, also confirmed by the abdominal US. Afterward, biliary sphincterotomy and extraction of stones either by balloon sweeping of the biliary duct or Dormia basket extraction was performed.

As regards complications in our study, only one patient (3.7%) developed mild pancreatitis and was treated successfully with conservative treatment without any harm to the fetus or mother and this was within the range of that observed in general populations (1.6–15.7%), and one patient with minor bleeding during the procedure that treated by washing by epinephrine and bleeding stopped and not needed any further intervention. Also, it is noted that the usual post‑ERCP complications including post-sphincterotomy bleeding, infection, pancreatitis, and perforation can have greater consequences in a pregnant woman [9]. Regarding pancreatitis, it was found to range from 0 to 4% in three previous studies [11, 25, 26]. In the study by Shelton et al. [11], post-ERCP pancreatitis was reported in one of 21 patients, which can be considered as similar to our study. A recent study from China [30] reported PEP in one of 68 patients (1.5%).

In a study by Tang et al. [27], they reported on 65 pregnant patients who underwent 68 ERCP procedures, and as a result, they recommended the use of a non-fluoroscopic technique which can be performed safely during pregnancy; however, it may associated with a higher rate of post-ERCP pancreatitis than in general population as noted in the study with a ratio of 16% [27].In comparison with our study, the lower rate of pancreatitis might be attributed to the younger age of our patients and the use of US guidance during the procedure. [30].In many previous studies, the risk of post-ERCP pancreatitis has been estimated at 5%, increasing to about 16% in pregnant women [4]. In general, it is well-established that prolonged endoscopic manipulation, sphincterotomy, and pancreatic contrast injection are risk factors for post-ERCP pancreatitis [17]. Moreover, in a study on 58 pregnant patients undergoing ERCP, the risk of post-ERCP pancreatitis was estimated at 12%; the increased rate as compared to non-pregnant patients (5%) was attributed to the limited use of fluoroscopy for guiding the wire during deep biliary cannulation [30].

The complication rate in our study was low and maternal and fetal outcomes were favorable. Cannulation was successfully achieved in all patients; our results are similar to a study from China that proposed that trans-abdominal US-guided ERCP was preferred over other conventional non-radiation ERCP because of the higher stone clearance and lower complication rates [30].

As regards the duration of the procedure, the time ranged from 19 to 45 minutes (Mean: 27 ± 13 min). This relatively long time is comparable to conventional ERCP, mostly due to the time needed for abdominal us in every case to confirm successful cannulation and clearance and due to time lost in changing patients position from left lateral decubitus to supine position for US examination, and then, shift the patient to left lateral position again, and also the lack of contrast injection and fluoroscopic evaluation was compensated for by the US assessment.

As regards biliary stent, in our study, a biliary stent was placed in 6 patients (22.22% ) (two patients with failed clearance and 4 patients we did not find any stone most probably passed stone and to guard against cholangitis. However, in a study by Abdo et al., on ten patients in Ismailia Egypt, they reported a two-stage procedure, biliary stent under the US guidance, and then after 2 months of delivery stent was removed and clearance under fluoroscopy [31].

In our study, no cases of abortion or preterm delivery were documented, which might be related to the absence of fluoroscopy with its teratogenic effects and the shorter duration of the procedure, which can decrease the dose of anesthetics needed and the use of safe anesthetic medications.

Ethics approval and consent to participate:

This study was approved by Local Medical Ethics Committee of South Valle University, Egypt, with IRB Number (SVU-MED-SUR11-4-23-3-601).

Study Registration:

The study was registered in clinical trials.com with identifying number: NCT06092905. The registration page found at: ClinicalTrials.gov PRS: Record Summary NCT06092905

Author Disclosures:

Abdallah Taha, Ahmad Saada and Mohmed Abdelshafy have no conflicts of interest or financial ties to disclose.

Authors' contributions:

Taha prepared the study design, collected patients’ data, performed statistical analysis, interpreted the results and wrote the manuscript. All authors participated in collection of data, revision of the manuscript before submission.

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No competing interests reported.

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Endoscopic Common Bile Duct Stones Clearance During Pregnancy: Challenges and solutions. A retrospective Cohort Study

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