Table 1. Characteristics of included studies.
| Author | Year | Study location | Ethnicity | Study design | Criteria for IgG4-RD | IgG4-RD disease (No.) | Control (No.) | Risk of bias* | Applicability concerns* |
|---|---|---|---|---|---|---|---|---|---|
| Aparisi et al. | 2005 | Spain | Caucasian | NR | Histopathological, clinical, and laboratory parameters | AIP (25) | ICP (29) | P† | No |
| Boonstra et al. | 2014 | Dutch | Caucasian | Prospective | Mayo Clinic’s HISORt criteria | IAC (73) | PSC (n = 310) | P | No |
| Carruthers et al. | 2015 | USA | Caucasian | NR | International pathology consensus guideline (2012) | IgG4-RD (72) | AID (n = 11), other disease (n = 397) | P | No |
| Choi et al. | 2007 | Korea | Asian | NR | Asan Medical Center of Korea | AIP (30) | PC (n = 76); CP (n = 67) | P | No |
| Ghazale et al. | 2007 | USA | Caucasian | Prospective | Mayo Clinic’s HISORt criteria | AIP (45) | PC (n = 135), other pancreatic diseases (n = 268); other disease (n = 62) | P | No |
| Hamano et al. | 2001 | Japan | Asian | Retrospective | Ultrasonographic, clinical, and laboratory performance | AIP (20) | PC (n = 70), CP (n = 45), PBC (n = 20), PSC (n = 8), SS (n = 11), HC (n = 20) | P | No |
| Hirano et al. | 2006 | Japan | Asian | Retrospective | Japan Pancreas Society | AIP (35) | CP (n = 24), PSC (n = 11), PC (n = 23), biliopancreatic cancer (n = 23) | P | No |
| Kaji et al. | 2012 | Japan | Asian | Prospective | AIP: Asian criteria (Japan–Korea) and ICDC | AIP (35) | PC (n = 17), CP (n = 24), PSC (n = 7), biliary cancer (n = 23) | P | No |
| Kamisawa et al. | 2008 | Japan | Asian | Retrospective | Radiological, serological histological examination | AIP (17) | PC (n = 33) | P, I# | I |
| Masaki et al. | 2012 | Japan | Asian | Retrospective | Pathological and clinical manifestations | IgG4-RD (132) | SS (n = 33), other non-AID (n = 15) | P, I | I |
| Mavragani et al. | 2014 | Greece | Caucasian | Retrospective | Comprehensive criteria | IgG4-RD (7) | SS (n = 126)* | P | No |
| Nakazawa et al. | 2012 | Japan | Asian | Retrospective | IgG4-SC: Japanese criteria 2006; AIP: HISORt criteria | IAC (47) | PC (n = 26), PSC (n = 21), CCA (n = 18) | P, I | I |
| Ohara et al. | 2013 | Japan | Asian | Retrospective | ICDC, revised Japanese criteria | IAC (344) | PC (n = 245), PSC (n = 110), CCA (n = 149) | P | No |
| Oseini et al. | 2011 | USA | Caucasian | Prospective | Mayo Clinic’s HISORt criteria | IAC (97) | CCA (n = 287) | P | No |
| Sanchez-Castanon et al. | 2012 | Spain | Caucasian | Retrospective | Mayo Clinic’s HISORt criteria | AIP (12) | CP (n = 23), ICP (n = 26), AP (n = 11), PC (n = 21), SS (n = 9), T1DM (n = 40), HC (n = 45) | P | No |
| Su et al. | 2015 | China | Asian | NR | Japan criteria | IgG4-RD (12) | AID (n = 127), other disease (n = 818) | P | No |
| Szántó et al. | 2014 | Japan | Asian | NR | Japanese Research Committee (2011) | AIP, MD (8) | SS (n = 43) | P | No |
| Tabata et al. | 2011 | Japan | Asian | Prospective | AIP: Asian criteria (Japan–Korea); MD: Clinical performance and exclusive criteria | AIP, MD (66) | Other pancreatobiliary or salivary gland diseases (n = 488) | P | No |
| Tanaka et al. | 2015 | Japan | Asian | Retrospective | Japanese Biliary Association (2012) | IAC (38) | PSC (n = 120) | P, I | I |
| Uehara et al. | 2005 | Japan | Asian | NR | Histopathological, clinical, and laboratory parameters | AIP-SC (6) | PSC (6) | P | P |
| Van Heerde et al. | 2014 | Dutch | Caucasian | Prospective | ICDC, Asian or HISORT criteria, or comprehensive criteria | AIP (33) | PC (n = 53) | P | P |
| Wu et al. | 2013 | China | Asian | Retrospective | Pathological and radiologic manifestations | AIP (15) | Non-AIP (n = 4) | P, I | No |
| Yamamoto et al. | 2012 | Japan | Asian | NR | Mayo Clinic’s HISORt criteria; Japan criteria | AIP, MD, CFSA, DA (102) | AID (n = 206), other disease (n = 72), HC (n = 21) | P | P |
IgG4-RD: IgG4-related disease; AIP: autoimmune chronic pancreatitis; MD: Mikulicz’s disease; IAC: IgG4-associated cholangitis; CFSA: Chronic fibrosing sialoadenitis; DA: IgG4-related dacryoadenitis; PC: pancreatic cancer; CP: chronic pancreatitis other than AIP; ICP: idiopathic chronic pancreatitis; PBC: primary biliary cirrhosis; SS: Sjögren’s syndrome; CCA: cholangiocarcinoma; HC: healthy control; T1DM: type 1 diabetes mellitus; AID: autoimmune diseases; ICDC: International consensus diagnostic criteria; NR: not reported. *QUADAS score; †P: patient selection; #I: index test.