Clinical Question #1

Can EUS-BD be considered as first option for biliary drainage of distal malignant biliary obstruction?

Statement #1

i-EUS group recommends EUS-CDS as an alternative to ERCP as first attempt for biliary drainage in patients with unresectable distal malignant biliary obstruction. (Level of evidence: 2; Grade of recommendation: strong)

Clinical Question #2a

Is biliary drainage indicated in patients with resectable distal malignant biliary obstruction?

Statement #2a

i-EUS group recommends against routine preoperative biliary drainage in patients with resectable distal malignant biliary obstruction. (Level of evidence: 1, grade of recommendation: strong)

Clinical Question #2b

Is biliary drainage indicated in patients with resectable distal malignant biliary obstruction?

Statement #2b

i-EUS group recommends preoperative biliary drainage in patients with cholangitis, severe jaundice, in those planned for neoadjuvant therapy and when a delay in surgery is anticipate. (Level of evidence: 1, grade of recommendation: strong)

Clinical Question #3a

How biliary drainage should be performed in non-surgical candidate patients with distal MBO when ERCP fails?

Statement #3a

i-EUS group recommends EUS-guided biliary drainage over PTBD after failed ERCP in malignant unresectable distal MBO.

(Level of evidence: 1, grade of recommendation: strong)

Clinical Question #3b

How biliary drainage should be performed in non-surgical candidate patients with distal MBO when ERCP fails?

Statement #3b

i-EUS group suggests that repeated ERCP or percutaneous rendezvous-ERCP could be considered as second line choices after ERCP failure

(Level of evidence: 3, grade of recommendation: weak)

Clinical Question #4

Which type of sedation should be preferred for EUS-BD in distal MBO?

Statement #4

i-EUS group suggests performing EUS-BD under deep sedation or general anaesthesia; the choice between these two options should be based on patient clinical condition and anaesthesiologist preference.

(Level of evidence: 4, grade of recommendation: weak)

Clinical Question #5

In which setting should EUS drainage be performed?

Statement #5

i-EUS group suggests performing EUS-guided biliary drainage in an endoscopy room equipped with fluoroscopy.

(Level of evidence: 4, grade of recommendation: weak)

Clinical Question #6

Which is the method of choice for EUS-BD in patients with distal MBO after ERCP failure?

Statement #6

i-EUS recommends EUS-choledocoduodenostomy (EUS-CDS) for the treatment of distal malignant biliary obstruction (MBO) after ERCP failure. EUS-HGS could be considered in case of unapproachable EUS-CDS in unresectable patients.

Level of evidence = 3

Grade of recommendation = strong

Clinical Question #7

Could EUS-GBD be considered as a rescue strategy in patients with distal MBO when other EUS-BD approaches are not feasible?

Statement #7

i-EUS suggests to consider EUS-GBD as a rescue strategy for biliary drainage in unresectable patients with distal MBO and patent cystic duct when other EUS-BD approaches are not feasible.

Level of evidence = 4

Grade of recommendation = weak

Clinical Question #8a

In patients with distal MBO undergoing EUS-CDS, has the use of LAMS advantages over SEMS?

Statement #8a

i-EUS suggests the use of either self-expandable metal stents (SEMS) or lumen-apposing metal stents (LAMS) for EUS-guided choledochoduodenostomy (EUS-CDS).

Level of evidence = 3

Grade of recommendation = weak

Clinical Question #8b

In patients with distal MBO undergoing EUS-CDS, has the use of LAMS advantages over SEMS?

Statement #8b

The use of electrocautery enhanced LAMS should be preferred in patients with dilated common bile duct undergoing EUS-CDS due to technical advantages.

Level of evidence = 5

Grade of recommendation = strong 

Clinical Question #9

In patients with distal MBO undergoing EUS-CDS, the use of 6 mm LAMS allows advantages over ≥ 8 mm LAMS?

Statement #9

i-EUS states that the use of 8 x 8 mm might be preferred over 6 x 8 mm LAMS for EUS-CDS.

Level of evidence = 4

Grade of recommendation = weak

Clinical Question #10

In patients with distal MBO undergoing EUS-CDS with LAMS (any size) the use of co-axial double pig-tail plastic stents (DPPS) is of any advantage?

Statement #10

There is no evidence to suggest or suggest against DPPS placement through the LAMS in patients undergoing EUS-CDS. i-EUS states that DPPS placement could be considered in selected cases.

Level of evidence = 4

Grade of recommendation = weak

Clinical Question #11

In patients undergoing EUS-HGS, is the use of dedicated stents (partially-covered stents with uncovered distal portion, covered proximal portion, anti-migration flange/flap) of any advantage over the use of other stents (fully-covered SEMS, uncovered SEMS with a fully-covered SEMS inside, DPPS)?

Statement #11

i-EUS suggests the use of dedicated stents over non-dedicated stents in patients undergoing EUS-HGS for distal malignant biliary obstruction.

Level of evidence = 5

Grade of recommendation = weak

Clinical Question #12

In the setting of malignant gastric outlet obstruction, should EUS-Gastroenterostomy be preferred over Enteral Stenting?

Statement #12

i-EUS suggests that EUS-GE may be preferred over Enteral Stenting in patients with malignant Gastric Outlet Obstruction in centers with adequate expertise in interventional EUS (Level 3 evidence, Weak recommendation)

Clinical Question #13

In the setting of concomitant biliary and gastric outlet malignant obstruction, what is the best modality to achieve biliary drainage?

Statement #13

i-EUS suggests that, in the setting of double obstruction, ERCP may be attempted whenever the papilla is reachable (especially in type 1 or 3 stenosis) or in case of previously placed duodenal stent.

i-EUS suggests that, in naïve patients with double obstruction, EUS-guided double bypass may be considered. (Level 4 evidence; Weak recommendation)

Clinical Question #14

In the setting of Duodenal stenosis, is there any difference between the extrahepatic and intrahepatic access for EUS-guided biliary drainage?

Statement #14

i-EUS suggests that, in the specific setting of double obstruction, EUS-HGS may be favoured over EUS-CDS due to longer stent patency (Level 4 evidence; Weak recommendation).

Clinical Question #15

Does potential surgical resectability represent a contraindication to EUS-guided biliary drainage? Which biliary drainage should be performed in patients with resectable distal MBO?

Statement #15

i-EUS suggests either ERCP or EUS-guided CholedochoDuodenostomy as the first line treatment of resectable distal malignant biliary obstruction. (Level 4 evidence; Weak recommendation).

Clinical Question #16

Does potential surgical resectability represent a contraindication to EUS-guided biliary drainage? Which biliary drainage should be performed in patients with localized malignancies candidates to neoadjuvant therapy?

Statement #16

i-EUS suggests either ERCP or EUS-guided CholedochoDuodenostomy In case of potentially resectable diseases scheduled for neoadjuvant chemotherapy (Level 4 evidence; Weak recommendation).

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Clicnical Question #17a

How does EUS-BD compares with other endoscopic, surgical or percutaneous approaches in achieving biliary drainage in patients with post-surgical anatomy?

Statement #17a

In patient with malignant distal biliary stenosis and surgical altered anatomy, treatment choice depends on disease extension and type of reconstruction.

i-EUS suggests to consider EUS-BD over laparoscopic-/enteroscopy-assisted ERCP and PTBD in patient with Roux-en-Y anatomy (Level 4 evidence, Weak recommendation).

Clicnical Question #17b

How does EUS-BD compares with other endoscopic, surgical or percutaneous approaches in achieving biliary drainage in patients with post-surgical anatomy?

Statement #17b

In patient with malignant distal biliary stenosis and surgical altered anatomy, treatment choice depends on disease extension and type of reconstruction.

i-EUS suggests to consider either EUS-BD or ERCP with lateral-viewing or cap-assisted frontal-viewing endoscopes in patients with Billroth II reconstruction (Level 5 evidence, Weak recommendation).

Clinical Question #18

Considering the interplay between ERCP and EUS, and the possibility of same-session procedures, should we obtain a “goal-based” informed consent for endoscopic biliary drainage, overcoming the concept of “technical-based” ones?

Statement #18

I-EUS suggests to obtain a “goal-based” informed consent for endoscopic malignant biliary drainage prior to   either EUS-guided drainage or conventional ERCP.

  (Level of evidence: 5; Grade of recommendation: weak)

Clinical Question #19

Who should take care of patients requiring biliary drainage? Is multidisciplinary management associated with better outcomes?

Statement #19

I-EUS suggests multidisciplinary discussion of patients with distal malignant obstruction in whom   the biliary drainage could impact on the main outcomes, in particular patients with resectable   cancer, altered anatomy and double obstruction.

  (Level of evidence: 5, grade of recommendation weak)

Clinical Question #20

Does endoscopic biliary drainage need to be performed in a referral setting?

Statement #20

I-EUS suggests endoscopic biliary drainage to be performed in a setting, where adequate   competencies in treatment of bilio-pancreatic disorders are available.   (Level of evidence: 5, grade of recommendation weak)

Clinical Question #21

Should antibiotics be administered to reduce the risk of post-procedural complications after EUS-guided biliary drainage?

Statement #21

iEUS does not suggest the routine use of antibiotic prophylaxis, to reduce the risk of post-  procedural complications after EUS-guided biliary drainage. iEUS suggest that antibiotic prophylaxis should be offered in selected patients. (Level of evidence: 5, Grade of recommendation: weak).

Clinical Question #22

Should periprocedural administration of drugs be considered to improve endoscopic outcomes after stent placement?

Statement #22

iEUS suggests not to use of ursodeoxycholic acid (UDCA) since it is not effective in preventing   recurrent biliary obstruction after SEMS placement and may increase the risk of stent occlusion. (Level of evidence: 4, Grade of recommendation: weak)

Clinical Question #23

Is a special diet suggested after biliary drainage?

Statement #23

I-EUS does not suggest any specific diet after EUS-guided biliary drainage to prevent stent   disfunction. (Level of evidence: 5; Grade of recommendation: weak)