Outcomes of Endoscopic Ultrasound-Guided Hepaticogastrostomy Using a 22G Needle Combined with a Double-Guidewire Technique

Abstract

Objectives Endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) is an increasingly used alternative treatment for malignant biliary obstructions. However, improvements to this approach are warranted. Recently, the use of a 22G puncture needle and a 0.018-inch guidewire (GW), as well as the double-GW technique (DGT), have been introduced and adopted by our institution. We retrospectively evaluated the outcomes of EUS-HGS, combined with DGT, using a 22G needle.

Patients and Methods This study included 34 of 54 patients who underwent EUS-HGS, which was performed using a 22G puncture needle combined with DGT at Kitasato University Medical Center Hospital from October 2021 to March 2024. We retrospectively examined patients' backgrounds, the technical success rate (defined as the successful insertion of a stent from the stomach into the intended bile duct), clinical success rate (defined as a decrease in total bilirubin levels to either the normal range or to at least 50% of the prior value within 2 weeks), procedure time (defined as the time from endoscope insertion to stent deployment), incidence of complications, and changes in the angle between the puncture axis and bile duct axis resulting from the use of DGT.

Endpoints and Data Analysis The primary endpoint was the technical success rate of EUS-HGS using a 22G needle combined with a DGT. Secondary endpoints included the clinical success rate, procedure time, GW angle at the puncture site before and after DGT, and incidence of complications. Descriptive statistics were performed.

Results The technical and clinical success rates were 100 and 97.1%, respectively. The average procedure time was 16 minutes. The angle between the puncture and bile duct axis was 145.6 degrees before the DGT, which only involved a 0.018-inch GW; the angle increased to 161.1 degrees after the DGT, bringing the puncture and bile duct axis closer to alignment. The incidence of complications was 2.9%.

Conclusion EUS-HGS with a 22G needle in conjunction with the DGT has a high procedural success rate and low incidence of complications. These two components complement each other and contribute to the overall efficiency and effectiveness of the procedure, even in challenging situations.

Keywords

endoscopic ultrasound-guided hepaticogastrostomy - obstructive jaundice - punctures

Introduction

Endoscopic retrograde cholangiopancreatography (ERCP) is the standard therapeutic approach for malignant biliary obstruction.[1] [2] [3] However, access to the duodenal papilla can be challenging in cases of duodenal stenosis or postoperative reconstruction, and ERCP may fail if bile duct intubation is difficult.

Endoscopic ultrasound (EUS)-guided biliary drainage, particularly EUS-guided hepaticogastrostomy (EUS-HGS), has rapidly gained traction in recent years as an alternative treatment for ERCP failure, duodenal stenosis, and postoperative intestinal reconstruction.[4] [5] [6] [7] [8] [9] [10] [11]

Although the outcomes of EUS-HGS are generally positive,[4] [5] [6] [7] [8] [9] [10] [11] with studies reporting favorable success rates and safety profiles,[4] [5] [6] [7] [8] [9] [10] [11] these outcomes are often confined to high-volume centers with extensive expertise in advanced endoscopic procedures. In such centers, experienced endoscopists and multidisciplinary teams are better equipped to handle the technical complexities and potential complications associated with EUS-HGS. However, even at these centers, the treatment success rate is not 100%, and the incidence of procedural complications has been reported to range from 3.8 to 21.2%,[4] [5] [6] [7] [8] [9] [10] [11] with some potentially detrimental complications, such as bile leakage.

In a typical EUS-HGS procedure, a 19G needle is used for puncture, and after imaging, a 0.025-inch guidewire (GW) is placed within the bile duct. The fistula is dilated, followed by stent placement. With the wide adoption of EUS-HGS, various procedural tips have been reported by previous studies.[12] [13] Coupled with advancements in treatment devices, the outcomes of this procedure have improved. However, challenges remain in cases where the bile duct is thin and difficult to puncture or when placing a GW.

Recently, a new 0.018-inch GW (18 GW: Fielder18; Olympus, Tokyo, Japan) was introduced in Japan. It is easier to maneuver than the previous 0.018-inch GW, and owing to its coating, it promotes safer procedures.[14] [15] [16] Using this GW facilitated EUS-HGS with a 22G needle. A thinner puncture needle makes it easier to puncture narrow bile ducts, and the reduced rigidity enhances the angle of approach.[16] This allows for greater flexibility in selecting the bile ducts for puncture and adjusting the puncture angle, potentially making the procedure easier than that with a 19G needle. Additionally, optimizing the puncture angle with the bile duct may facilitate easier placement of the GW in the desired bile duct. Furthermore, using a 22G puncture needle may help reduce complications such as bleeding.

However, using a 0.018-inch GW can have certain limitations compared with using a 0.025-inch GW, such as decreased rigidity and reduced delivery performance. These factors make the procedure more challenging and potentially complicate fistula dilation or stent insertion.

Recently, Shiomi et al[17] and Nakai et al[18] introduced the double-GW technique (DGT) using an uneven double-lumen catheter (UDLC; Piolax Medical, Kanagawa, Japan) ([Supplementary Fig. S1], online only) to prevent GW displacement after fistula dilation during ultrasound-guided treatment. This technique enhances the scope stability and improves delivery performance.[17] [18] [19] [20] By adding a 0.025-inch GW for DGT, the limitations of the 0.018-inch GW's lower delivery performance can be mitigated, allowing EUS-HGS to be performed more safely and effectively. The combination of EUS-HGS using a 22G needle and the DGT is expected to bring about synergistic outcomes; however, there have been no previous studies on the treatment outcomes of EUS-HGS using this combination.

Therefore, we retrospectively examined the treatment outcomes of EUS-HGS using a 22G needle in combination with a DGT.

Materials and Methods

Study Design and Ethical Statement

This single-center, retrospective cohort study was conducted at Kitasato University Medical Center in Japan. The study was performed in accordance with the Declaration of Helsinki and was approved by the Institutional Review Board (IRB) of the University (IRB approval number: 2024006). All participants provided written informed consent before the procedure.

Target Cases

We retrospectively reviewed the medical records of consecutive patients who underwent EUS-HGS at Kitasato University Medical Center between October 2021 and March 2024. Of the 53 patients who underwent EUS-HGS during this period, those who met the inclusion criteria were selected and those who met the exclusion criteria were excluded. The inclusion criteria were patients who underwent EUS-HGS, which was performed using a 22G puncture needle, followed by treatment with DGT. The exclusion criteria were as follows: (1) cases where EUS-HGS was performed using a 19G puncture needle, (2) cases where EUS-HGS was performed using a 22G puncture needle but without a DGT, or where DGT was performed with a combination other than the 0.018-inch and 0.025-inch GW, and (3) cases with insufficient data, such as unclear details on the type of puncture needle or GW used. Ultimately, 34 patients fulfilled the eligibility criteria ([Supplementary Fig. S2], online only). Data were collected from electronic medical records or endoscopy databases.

EUS Scope When Inserting a 22G Puncture Needle

[Fig. 1] illustrates the EUS (UCT260; Olympus Medical Systems, Tokyo, Japan) with and without a puncture needle. Without the needle, the maximum upward angle was 130 degrees ([Fig. 1A]). When a 22G puncture needle (EZ Shot3 Plus; Olympus, Tokyo, Japan) was inserted, the maximum upward angle was 115 degrees ([Fig. 1B]), whereas with a 19G puncture needle (EZ Shot3 Plus), the maximum upward angle was 90 degrees ([Fig. 1D]). Thus, the upward angle was wider with the 22G puncture needle than that with the 19G puncture needle.

Fig. 1 Comparison of the same endoscopic ultrasound (EUS) scope with no needle inserted, a 22G needle inserted, and a 19G needle inserted. (A) No puncture needle is inserted into the EUS scope, and the upward angle is set to its maximum. (B) A 22G puncture needle is inserted, the upward angle is set to its maximum, and forceps are not in use. (C) A 22G puncture needle is inserted, the upward angle is set to its maximum, and forceps are raised to their maximum position. (D) A 19G puncture needle is inserted, the upward angle is set to its maximum, and forceps are not raised to their maximum position. (E) A 19G puncture needle is inserted, the upward angle is set to its maximum, and forceps are raised to their maximum position.

Furthermore, when the upward angle was set to its maximum, the elevator was also set to its maximum, as shown in [Fig. 1C] and [E]. When a 22G puncture needle was used, the angle of the needle shifted by approximately 25 degrees relative to that of the elevator ([Fig. 1C]). Contrastingly, using the 19G puncture needle, the angle changed by approximately 10 degrees under the same conditions ([Fig. 1E]). This demonstrates that a 22G puncture needle allows for a more sensitive adjustment of the endoscope and forceps angles, facilitating easier selection of the puncture angle compared with a 19G needle.

Uneven Double-Lumen Catheter ([Supplementary Fig. S1], Online Only)

The UDLC ([Supplementary Fig. S1], online only) was used to perform the DGT. This catheter has two distinct lumens: one at the tip, designed for the insertion of a 0.025-inch GW, and a side lumen that accommodates an additional 0.035-inch GW. The body of the UDLC measures 6 Fr, whereas its tapered tip (3.6 Fr) is compatible with a 0.025-inch GW, allowing for smoother insertion through the fistula.

EUS-HGS Method ([Video 1], Online Only)

Video 1 EUS-HGS with a 22G needle and DGT. This video demonstrates EUS-HGS using 22G needle and DGT. First step is puncture using 22G needle and contrast injected. Next, a 0.018 inch guidewire inserted, then UDLC inserted without prior fistula dilation, and bile was aspirated. Next, additional 0.025 inch guidewire inserted, DGT was performed. At last, 7 Fr PS was inserted without additional fistula dilation. DGT, double-guidewire technique; EUS-HGS, endoscopic ultrasound-guided hepaticogastrostomy; GW, guidewire; PS, plastic stent; UDLC, uneven double-lumen catheter.

Scope and Observation Device

A linear EUS was used, and the observation device employed was ME-2 (Olympus Medical Systems, Tokyo, Japan). All procedures were performed by two experts with experience in EUS-HGS, each with > 20 cases worth of experience.

EUS-HGS

The procedure involved visualizing the left lobe of the liver from within the stomach and identifying the intrahepatic bile ducts of segments 2 (B2) and 3 (B3). Puncture was generally attempted from B3, although B2 was also considered if it was confirmed that it was not a transesophageal puncture. After ensuring that no intervening blood vessels were present, a 22G fine-needle aspiration (FNA) puncture needle (EZ Shot3 Plus; Olympus, Tokyo, Japan, or Sonotip Pro Control; Medi-Globe GmbH, Rosenheim, Germany) was used. Following the puncture, suction was performed to confirm bile aspiration, and contrast was injected to visualize the bile duct. A 0.018-inch GW (18 GW; Fielder 18; Olympus, Tokyo, Japan) was placed in the bile duct, followed by the insertion of a 0.025-inch GW (25 GW; Visiglide 2; Olympus, Tokyo, Japan) using a UDLC. After placing the UDLC in the bile duct, at least 10 mL of bile was aspirated. If necessary, the fistula was dilated using a bougie dilator (ES Dilator; Zeon Medical Co., Tokyo, Japan), drill-type dilator (Torunus ES; Olympus, Tokyo, Japan), or thin-diameter balloon dilator (REN; Kaneka, Osaka, Japan). Fistula dilation is typically performed when DGT is selected. However, if the UDLC cannot be inserted, dilation is performed before the UDLC insertion. After fistula dilation, a stent was placed to connect the bile duct to the stomach. The stents used include 7 Fr plastic stents (PS; 7 Fr, 14 cm, single pigtail type, Type IT stent; Gadelius Medical, Tokyo, Japan) or 8-mm diameter partially covered self-expandable metallic stents (SEMS) with a 10- or 15-mm uncovered tip (8 mm, 10/12 cm NITI-S S-TYPE STENT/Spring stopper; Taewoong Medical Co. Ltd., Gimpo, Korea).

In some cases, an antegrade stent (AS) is added during EUS-HGS. For AS placement, a GW was inserted ([Fig. 2B]), and a UDLC was used to navigate through the stenosis and place the GW ([Fig. 2C] and [D]). Following this, without dilating the fistula, an 8-mm diameter uncovered SEMS (YABUSAME/YABUSAME NEO; Kaneka, Osaka, Japan) was placed at the site of the stricture ([Fig. 2E]). Stent placement, either above or across the papilla, depends on the stricture location. If insertion is difficult, additional fistula dilation may be performed as needed. After the AS was placed, a PS was inserted into the HGS route to complete the procedure ([Fig. 2F]).

Fig. 2 Endoscopic ultrasound-guided hepaticogastrostomy (EUS-HGS) + antegrade stent (AS) with a 22G needle and double-guidewire technique (DGT). (A) B3 was punctured with a 22G needle, and cholangiography was performed. (B) The bile duct was imaged, and a 0.018-inch guidewire (GW) was placed. (C) A uneven double-lumen catheter (UDLC) was inserted into the bile duct, bile was aspirated, and additional imaging was performed. (D) An additional 0.025-inch GW was inserted, and DGT was performed. (E) A stent delivery for AS was inserted into the stenosis, and an AS was placed in the stenosis. (F) A plastic stent (PS) was placed to connect the stomach and bile duct, and the HGS + AS procedure was completed. AS, antegrade stent, B3, intrahepatic bile duct in segment 3; DGT, double-guidewire technique; EUS-HGS, endoscopic ultrasound-guided hepaticogastrostomy; GW, guidewire; PS, plastic stent; UDLC, uneven double-lumen catheter.

Post-EUS-HGS Treatment

Blood tests and plain computed tomography (CT) scans were performed on the day after EUS-HGS to check for complications. Blood tests were conducted to assess the decrease in bilirubin levels and monitor for signs of anemia progression or elevated inflammatory markers. CT scans were used to evaluate bile leakage and the presence of free air and to ensure that there were no abnormalities in stent positioning.

Definition and Endpoints and Data Analyses

Technical success was defined as the successful insertion of a stent from the gastrointestinal tract (stomach) into the intended bile duct. Clinical success was defined as a decrease in total bilirubin levels to either the normal range or to at least 50% of the prior value within a 2-week period.

Bile duct diameter was measured using an ultrasound endoscope during the procedure. Procedure time was defined as the time from endoscope insertion to stent deployment. The angle of the GW at the puncture site was evaluated using fluoroscopic images to assess the angle from the endoscope to the puncture site and from the puncture site to the intrahepatic bile duct ([Supplementary Fig. S3], online only).

Adverse event severity was classified according to the American Society of Gastrointestinal Endoscopy lexicon.[21]

The primary endpoint was the technical success rate of EUS-HGS using a 22G needle combined with a DGT. Secondary endpoints included clinical success rate, procedure time, GW angle at the puncture site before and after DGT, and incidence of complications.

Statistical analyses were limited to descriptive statistics. Continuous variables are presented as medians (range), whereas categorical variables are expressed as numbers (percentages). No formal statistical tests were performed to compare groups.

Results

[Table 1] presents the characteristics of the 34 patients included in this study. The median age was 77.5 years (range: 54–98 years), with 18 males and 16 females. Pancreatic cancer was the most common underlying condition, occurring in 17 (50%) patients. Other diagnoses included biliary tract cancer in 10 patients (29.4%) and gastric cancer in 2 patients (5.9%). Thirty patients (88.2%) had malignant diseases, whereas four patients (11.8%) had benign diseases. The main indication for EUS-HGS was duodenal stenosis, with five cases (14.7%) involving postoperative intestinal reconstruction, excluding Billroth I reconstruction. The median total bilirubin level prior to the procedure was 3.8 mg/dL (range: 0.6–22.6 mg/dL).

Table 1 Baseline characteristics of 34 patients

	EUS-HGS (n = 34)
Age (median, range)	77.5 (54–98)
Gender (male/female)	18/16
Disease, n (%)
Malignant Pancreatic cancer  Biliary tract cancer Gastric cancer Duodenum cancer Benign Bile duct stone Chronic pancreatitis	30 (88.2%) 17 (50%) 10 (29.4%) 2 (5.9%) 1 (2.9%) 4 (11.8%) 3 (8.8%) 1 (2.9%)
Indication for EUS-HGS, n (%)
Duodenal stenosis Postoperative intestinal reconstruction Failed ERCP	28 (82.4%) 5 (14.7%) 1 (2.9%)
Total bilirubin level (median, range mg/dL)	3.8 (0.6–22.6)

Abbreviations: ERCP, endoscopic retrograde cholangiopancreatography; EUS-HGS, endoscopic ultrasound-guided hepaticogastrostomy.

[Table 2] details the EUS-HGS procedure. The median procedure time was 16.0 minutes (range: 11–67 minutes). The most frequently punctured bile duct was B3 in 24 cases, whereas B2 was punctured in 10 cases. The median diameter of the punctured bile duct was 3.2 mm (range: 1.0–8.4 mm), and the median number of punctures was 1 (range: 1–3). DGT was performed using the 18 and 25 GW in all cases. The UDLC was inserted without prior fistula dilation in 19 cases (55.9%). Our strategy for fistula dilation varies depending on the type of stent being placed. When placing an SEMS, balloon dilation is performed before inserting the delivery system. When placing a PS, the PS is initially inserted without fistula dilation after removing the UDLC. If insertion is difficult, additional dilation is performed using a bougie dilator. For fistula dilation, UDLC alone was used in 7 cases (20.6%), mechanical dilators in 15 cases (44.1%), drill dilators in 2 cases (5.9%), and balloon dilators in 10 cases (29.4%); no electrocautery dilators were used. [Supplementary Fig. S4] (online only) provides a detailed description of the dilation procedures. Among the 19 cases where the UDLC was inserted without prior dilation, 6 patients ultimately underwent SEMS placement, requiring additional balloon dilation after DGT. Among the 13 patients who received a PS, 7 cases allowed for direct PS placement after UDLC removal without additional dilation, whereas 6 cases required additional bougie dilation. In contrast, 15 cases required prior dilation before UDLC insertion. Among them, four cases ultimately underwent SEMS placement, with balloon dilation performed before UDLC insertion, followed by DGT and SEMS placement. Of the 11 patients who received a PS, 2 underwent drill dilator expansion before UDLC insertion, whereas 9 underwent mechanical dilation before UDLC insertion, followed by DGT and PS placement.

Table 2 Technical feature of EUS-HGS procedure

	EUS-HGS (n = 34)
Procedure time, min (median, range, min)	16.0 min (11–67)
EUS-HGS/EUS-HGS + AS, n	26/8
Puncture site (B2/B3), n	10/24
Bile duct diameter, mm (median, range mm)	3.2 mm (1.0–8.4)
Number of punctures, n (median, range)	1 (1–3)
Double GW (0.018 inch + 0.025 inch/0.025 inch + 0.025 inch), n	34/0
Successful UDLC insertion before fistula dilation, n (%)	19 (55.9%)
Method of additional dilation, n
None (UDLC only) Mechanical Drill Balloon Electrocautery	7 15 2 10 0
GW angle at insertion site before DGT, degree (median, range; degree)	145.6 degrees (103.4–163.5)
GW angle at insertion site after DGT, degree (median, range; degree)	161.1 degrees (128.5–172.2)
HGS stent type (SEMS/PS), n	10/24

Abbreviations: AS, antegrade stenting; B2, intrahepatic bile duct of segment 2; B3, intrahepatic bile duct in segment 3; DGT, double-guidewire technique; EUS-HGS, endoscopic ultrasound-guided hepaticogastrostomy; GW, guidewire; PS, plastic stent; SEMS, self-expandable metallic stents; UDLC, uneven double-lumen catheter.

The median GW angle before DGT, with only the 18 GW placed, was 145.6 degrees, increasing to 161.1 degrees after DGT, aligning the axis of the fistula more closely with the bile duct axis.

[Table 3] shows the treatment outcomes of EUS-HGS. Technical and clinical success rates were 100 and 97.1%, respectively. The absence of clinical improvement in one patient was attributed to multiple liver metastases. Although bilirubin levels exhibited an improving trend, they did not decrease to less than half within 2 weeks. EUS-HGS alone was performed in 26 patients (76.5%), and EUS-HGS combined with AS was performed in 8 patients (23.5%). The stents used included SEMS (10/12 cm) in 10 cases (8/2) (29.4%), PS alone in 16 cases (47.1%), and PS combined with AS in 8 cases (23.5%).

Table 3 Clinical outcome of EUS-HGS

	EUS-HGS (n = 34)
Technical success rate, % (n)	100% (34/34)
Clinical success rate, % (n)	97.1% (33/34)
EUS-HGS/EUS-HGS + AS, n	26/8
Type of stent, n
SEMS (10 cm/12 cm) PS PS + AS	10 (8/2) 16 8
Early adverse events, n (grade)	1
Biliary peritonitis  Cholangitis  Bleeding  Stent migration  Other	1 (mild) 0 0 0 0

Abbreviations: AS, antegrade stenting; EUS-HGS, endoscopic ultrasound-guided hepaticogastrostomy; PS, plastic stent; SEMS, self-expandable metallic stent.

Complications occurred in one patient (2.9%), presenting as mild peritonitis, which improved with conservative treatment.

Discussion

This study evaluated the results of EUS-HGS using a 22G puncture needle combined with the DGT. Although prior studies have reported these methods individually,[14] [15] [16] [17] [18] [19] [20] the combined approach used in this study is novel and potentially advantageous.

The results of using a 22G puncture needle combined with the DGT were promising compared with previous reports.[4] [5] [6] [7] [8] [9] [10] [11] [14] [15] [16] [17] [18] [19] [20] The use of a 22G needle facilitated easier puncture and enabled access to the thinner bile ducts. Ogura et al found that puncture resistance was lower with a 22G FNA needle than with a 19G FNA needle, making it easier to puncture a thin bile duct.[22] Additionally, the reduced rigidity of the 22G needle allowed better adjustment of the endoscope angle and forceps application ([Fig. 1]), which improved the alignment of the puncture angle with the bile duct. Previous reports from facilities with limited experience using 19G EUS-guided biliary drainage have indicated a success rate of 67.2%.[23] For EUS-HGS specifically, the success rate was 64.7%, with the primary issue being failure to place the GW. The ability to adjust the puncture angle more precisely with a 22G needle likely improved the GW placement, contributing to the high success rate observed in this study. The use of a 22G needle may have facilitated better guidance of the GW toward the hepatic porta side, overcoming the challenges associated with the angle of the needle and bile duct.

When using a 22G puncture needle, the compatible GW is typically 0.018 inches. Although the 18 GW used in this study offers improved operability compared with the earlier 0.018-inch GWs, its thin diameter results in reduced rigidity and inferior delivery performance compared with a 0.025-inch GW. This complicates fistula dilation and stent placement. To address this limitation, we employed the DGT, which uses 0.018-inch and 0.025-inch GW. By utilizing the DGT, the stability of the scope and axis of the fistula is enhanced, improving the delivery performance of the GW and facilitating easier fistula dilation and stent insertion. Even without a DGT, switching from a 0.018-inch GW to a 0.025-inch GW can enhance delivery performance. However, DGT offers additional benefits by providing a backup GW in cases of complications such as GW deviation and by stabilizing the axis more effectively. Fujii et al[20] reported that DGT using two 0.025-inch GWs resulted in greater coaxial alignment of the puncture axis with the bile duct axis, leading to a more stable treatment. In our study, using a DGT with 0.018-inch and 0.025-inch GW achieved similar alignment improvements, confirming that this combination effectively stabilized the axis and enhanced the overall success of the procedure.

In this study, a UDLC was used to perform the DGT. Although stone retrieval balloon catheters have been reported for use in DGT,[24] the UDLC offers several advantages over balloon catheters. Specifically, the UDLC has a tapered tip and a thinner body, enhancing insertability and maneuverability. Additionally, because of its smaller diameter, the UDLC may help reduce bile leakage by minimizing the size of the fistula during instrument exchanges. Furthermore, the UDLC allows for the repositioning of the GW in cases where the initially placed GW advances only into the peripheral bile duct. In such situations, the UDLC can be inserted first, allowing a second GW to be advanced through the additional lumen, thereby enabling proper direction.[25] Given these advantages, the UDLC appears to be a valuable tool for performing DGT using GWs, offering improved procedural efficiency and safety.

Puncturing with a 22G catheter facilitates easier adjustment of the angle relative to the bile duct, allowing the GW to be directed more effectively toward the hepatic porta. This alignment helped flatten the bile duct and puncture axes, making the subsequent steps of fistula dilation and stent placement more manageable. The combination of this improved alignment with the stabilization provided by the DGT likely contributed to the high success rate observed in this study.

The incidence of complications was low (2.9%). Bile leakage during and after the procedure, which is a severe complication reported in previous studies,[10] [11] was observed as biliary peritonitis. Ishiwatari et al[26] noted that bile leakage can be minimized by inserting a contrast catheter for ERCP and performing bile aspiration. In our study, the bile was aspirated when a UDLC was introduced into the bile duct, which may have contributed to the low complication rate, including reduced instances of bile leakage.

Yane et al[27] highlighted the effectiveness of EUS-HGS using a 22G needle during the induction phase, and Ogura et al[22] demonstrated its efficacy in nonexpert settings. However, this study was conducted by experts, resulting in a high success rate, low complication rate, and short procedure time, indicating the efficacy of this method when performed by skilled practitioners. Nevertheless, there is the potential to further optimize the procedure by reducing its complexity. One challenge is the difficulty of inserting a UDLC after puncture and placement of a 0.018-inch GW, which occasionally necessitates expanding the fistula before UDLC insertion. Increased tool exchange can complicate the procedure, potentially extending the procedure time and increasing the risk of bile leakage.

In this study, the average procedure time was 16 minutes, and complications were minimal. These favorable outcomes are attributed to the expertise of practitioners and the benefits of the DGT, which aligned the GW axis more closely with the bile duct axis, facilitating smoother fistula dilation and stent placement. Reducing procedural complexity and tool exchange could further decrease the risk of bile leakage. Future advancements in treatment tools may address these issues and enhance the overall efficacy of the procedure.

This study had some limitations. First, as this retrospective analysis was conducted at a single institution, the sample size was relatively small. Additionally, this was a single-arm study; hence, it lacked comparisons with conventional methods, limiting its ability to assess relative efficacy. Furthermore, all procedures were performed exclusively by expert endoscopists, which may have introduced variability and bias based on the surgeon's technique. Some of the instruments used are only available in Japan, which may limit the generalizability of the procedure. Standardizing the results across practitioners could improve the generalizability of the findings. Future comparative studies with larger numbers of patients are needed.

Conclusion

EUS-HGS with a 22G needle in conjunction with the DGT demonstrates a high procedural success rate and low incidence of complications, making it a highly effective and valuable method. These two components complement each other and contribute to the overall efficiency and effectiveness of the procedure, even in challenging situations.

Conflict of Interest

None declared.

Acknowledgments

We would like to thank Editage (www.editage.jp) for English language editing.

Ethical Approval

The study was performed in accordance with the Declaration of Helsinki and was approved by the Institutional Review Board of Kitasato University Medical Centre (IRB approval number: 2024006). All participants provided written informed consent before the procedure.

Data Availability

The data presented in this study are available upon reasonable request from the corresponding author.

Authors' Contributions

M.K.: Supervision, writing–review, and editing; T.K.: Resources; G.K.: Resources; S.K.: Resources; T.B.: Resources; C.K.: Supervision; T.K.: Conceptualization, data curation, investigation, formal analysis, project administration, validation, visualization, and writing–original draft.

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Publication History

Article published online:
28 March 2025