Table Info

Table 4.

Studies comparing aggressive hydration with lactate Ringer plus indomethacin: study protocol design

Author (country, year) [ref]	Study design	Intervention protocol	Comparison	Type of NSAIDs	Number pts	Female gender (%)	Patient related PEP risk	Exclusion criteria
Mok et al. (USA, 2017) [47]	RCT (1:1:1:1), monocentre	LR + indomethacin (infusion protocol not available)	a. Standard NSS + placebo b. NSS + rectal indomethacin c. LR + placebo	Indomethacin 100 mg	48 per group	48 vs. 60 vs. 69 vs. 73	Average and high risk	Fluid overload increased risk* Active peptic ulcer Electrolyte alterations Pregnancy Age < 18 yrs Ampullectomy
Hajalikhani et al. (Iran, 2018) [48]	RCT (1:1), monocentre	3.0 mL/(kg h) during and for 8 h after ERCP, bolus of 20 mL/kg immediately after the procedure + diclofenac	Standard hydration [LR 1.5 mL/(kg h) during and for 8 h after ERCP, without bolus] + rectal diclofenac	Diclofenac 100 mg	107 intervention group 112 control group	53.3 vs. 49.1	Average and high risk	Gastrointestinal bleeding Fluid overload increased risk* Pregnancy Age < 18 and > 70 yrs
Thanage et al. (India, 2021) [49]	RCT (1:1:1), monocentre	3.0 mL/(kg h) during and for 8 h after ERCP, bolus of 20 mL/kg immediately after the procedure + diclofenac	a. Aggressive hydration with LR (same infusion protocol) b. Rectal diclofenac	Diclofenac 100 mg	57 per group	52.6 vs. 43.8 vs. 63.1	High risk	Acute pancreatitis Fluid overload increased risk* Active peptic ulcer Pregnancy Age < 18 yrs
Boal Carvalho et al. (Portugal, 2022) [50]	RCT (1:1), monocentre	3.0 mL/(kg h) during and for 8 h after ERCP, bolus of 20 mL/kg immediately after the procedure + indomethacin at the end of ERCP	Standard hydration [LR 1.5 mL/(kg h) during and for 8 h after ERCP, without bolus] + indomethacin at the end of ERCP	Indomethacin 100 mg	83 intervention group 72 control group	53 vs. 48.6	Average risk	Previous ERCP Low risk of PEP Acute pancreatitis Fluid overload increased risk* Electrolyte alterations Age < 18 yrs Post-surgical anatomy
Sperna Weiland et al. (Netherlands, 2021) [51]	RCT (1:1), multicentre	Bolus of 20 mL/kg within 60 min from the start of ERCP, followed by 3 mL/(kg h) for 8 h + rectal diclofenac	NSS with a maximum of 1.5 mL/(kg h) and 3 L per 24 h + rectal diclofenac	Diclofenac 100 mg	388 intervention group 425 control group	60 vs. 59	Average and high risk	Previous ERCP Pancreatic head mass Acute pancreatitis Chronic pancreatitis Sepsis Fluid overload increased risk* Active GI bleeding Electrolyte alterations Age < 18 and > 85 yrs Pregnancy Post-surgical anatomy

*: Cardiac, hepatic, respiratory or renal insufficiency/severe disease; ERCP: endoscopic retrograde cholangiopancreatography; LR: lactated Ringer’s; NSAIDs: non-steroidal anti-inflammatory drugs; NSS: normal saline solution; PEP: post-ERCP acute pancreatitis; pts: patients; RCTs: randomized controlled trials; yrs: years

Supplementary materials

The supplementary materials for this article are available at: https://www.explorationpub.com/uploads/Article/file/1001247_sup_1.pdf.

Declarations

Author contributions

VGM: Conceptualization, Investigation, Writing—original draft, Writing—review & editing. AL: Conceptualization, Validation, Supervision, Writing—review & editing. SG and FF: Writing—review & editing. RS: Validation, Supervision. All authors read and approved the submitted version.

Conflicts of interest

Vincenzo Giorgio Mirante is the Editorial Board Member of Exploration of Medicine. Amedeo Lonardo is the Associate Editor of Exploration of Medicine. They had no involvement in the decision-making or the review process of this manuscript.

Ethical approval

Not applicable.

Consent to participate

Not applicable.

Consent to publication

Not applicable.

Availability of data and materials

The data analyzed in this study was obtained from PubMed (https://pubmed.ncbi.nlm.nih.gov). Requests for access to these datasets should be directed to Vincenzo Giorgio Mirante (v.mirante@libero.it).

Funding

Not applicable.

Copyright

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