Additional File 9 - Studies of Adverse Events (Endoscopic Treatments)

Additional file 9 - Studies of adverse events (endoscopic treatments) No. ofStudy patients who Dysphagia Photosen.* Stricture Perfor.* Odynoph.* Bleed.* received treatmentPDT (ALA 15 mg/kg )Comparative studies - noneNon-comparative studies15.4% 23.1% 0% 0% 0% 0% Ortner MA, et al. 14 (2002)[26] (2/13) (3/13) (0/13) (0/13) (0/13) (0/13)0% 0% 0% 0% 0% Ortner M, et al. ‘Occasion- 9 (1997)[27] ally’ (0/9) (0/9) (0/9) (0/9) (0/9)15.4% 13.6% (3/22) 0% 0% 0% 0% Pooled total 23 (2/13) 0-23.1% (0/22) (0/22) (0/22) (0/22)PDT (ALA 30 mg/kg )Comparative studies0% 14.7% 0% 0% 2.9% 0% Kelty CJ, et al. 35 (2004)[14] (0/34) (5/34) (0/34) (0/34) (1/34) (0/34)Non-comparative studies0% 2.5% 0% 0% 0% 0% Ackroyd R, et al. 40 (2003)[28] (0/40) (1/40) (0/40) (0/40) (0/40) (0/40)Not Not Not Not Not Ackroyd R, et al. Not 5 (1997)[29] reported reported reported reported reported reportedNot Not Not Not Not Ackroyd R, et al. Not 7 (1999)[28] reported reported reported reported reported reported0% 0% 0% 0% 0% 0% Mackenzie G, et 16 al. (2005)[30] (0/16) (0/16) (0/16) (0/16) (0/16) (0/16)GI bleed:1 requiring 0% 0% 0% 0% 0% Mackenzie G, et transfusion 16 al. (2005)[22] (0/16) (0/16) (0/16) (0/16) (0/16) (see note 3 below)1 5.7% 0.9% 0% 0% 0% 0% Pooled total 119 (6/106) (1/106) (0/106) (0/106) (0/106) (0/90) 0-14.7% 0-2.9%PDT (ALA 40 mg/kg )Comparative studies-noneNon-comparative studies0% 0% 0% 0% 0% 0% Peters F, et al. 20 (2005)[32] (0/20) (0/20) (0/20) (0/20) (0/20) (0/20) van Hillegersberg 0% 0% 0% 0% 0% 0% R, et al. (2003) 2 [33] (0/2) (0/2) (0/2) (0/2) (0/2) (0/2)0% 0% 0% 0% 0% 0% Pooled total 22 (0/22) (0/22) (0/22) (0/22) (0/22) (0/22)PDT (ALA 60 mg/kg )Comparative studies0% 0% 0% 0% 0% 0% Behrens A, et al. 27 (2005)[25] (0/27) (0/27) (0/27) (0/27) (0/27) (0/27)0% 0% 0% 0% 92.3% 0% Hage M, et al. 26 (2004)[13] (0/26) (0/26) (0/26) (0/26) (24/26) (0/26)40.0% 0% 0% 0% 0% 0% Zoepf T, et al. 10 (2003)[16] (4/10) (0/10) (0/10) (0/10) (0/10) (0/10)Non-comparative studies0% 0% 0% 0% 0% 0% Barr H, et al. 5 (1996)[34] (0/5) (0/5) (0/5) (0/5) (0/5) (0/5)Not Not Not Not Not Gossner L, et al. Not 10 (1998)[35] reported reported reported reported reported reported0% 0% 0% 0% 0% 0% Gossner L, et al. 2 (1999)[36] (0/2) (0/2) (0/2) (0/2) (0/2) (0/2)0% 75.0% 0% 0% 0% 0% Kashtan H, et al. 8 (2002)[37] (0/8) (6/8) (0/8) (0/8) (0/8) (0/8)Mackenzie G, et 33 0% 0% 0% 0% 0% GI bleed:1 al. (2005)[22] requiring 2 transfusion (0/33) (0/33) (0/33) (0/33) (0/33) (see note 3 below)0% 0% 6.3% 0% 0% 0% Mackenzie GD, et 16 al. (2008)[38] (0/16) (0/16) (1/16) (0/16) (0/16) (0/16)0% 12.5% 0% 0% 0% Macrae FA, et al. 8 ‘Common’ (2004)[39] (0/8) (1/8) (0/8) (0/8) (0/8)7.7% 0% 0% 0% 0% 0% Mellidez JC, et al. 13 (2005)[40] (GI bleed (0/13) (0/13) (0/13) (0/13) (0/13) 1/13)1.4% 16.2% 0.9% 2.7% (4/148) 4.3% (6/140) 0% Pooled total 158 (2/148) (24/148) (1/115) 0-40.0% 0-75.0% (0/148) 0-12.5% 0-92.3% 0-7.7%PDT (HpD 1.5 mg/kg )Comparative studies - noneNon-comparative studies0% 40.0% 0% 0% 0% 0% Laukka MA, et al. 5 (1995)[41] (0/5) (2/5) (0/5) (0/5) (0/5) (0/5)0% 0% 0% 0% Wang KK, et al. 55 ‘Common’ ‘Common’ (1997)[42] (0/54) (0/54) (0/54) (0/54)Not Not Not Not Not Wang KK, et al. Not 50 (1999)[43] reported reported reported reported reported reported0% 40.0% 0% 0% 0% 0% Pooled total 110 (0/59) (2/5) (0/59) (0/59) (0/5) (0/59)PDT (mTHPC 0.15 mg/kg )Comparative studies - noneNon-comparative studiesNot Not Not Not Not Javaid B, et al. Not 6 (2002)[44] reported reported reported reported reported reportedNot Not Not Not Not Lovat LB, et al. Not 7 (2005)[45] reported reported reported reported reported reported3 Pooled total 13 -** -** -** -** -** -**PDT (Porfimer sodium 2mg/kg )Comparative studies 0% 15.4% 15.4% 0% 0% 0% Ragunath K, et al. 13 (2005)[15] (0/13) (2/13) (2/13) (0/13) (0/13) (0/13)Non-comparative studies0% 0% 36.8% 0% 0% 0% Attila T, et al. 19 (2005)[46] (0/19) (0/19) (7/19) (0/19) (0/19) (0/19)0% 0% 0% 0% 0% 0% Bronner M, et al. 138 (2006)[47] (0/138) (0/138) (0/138) (0/138) (0/138) (0/138)Not Not Not Not Not Keeley SB, et al. Not 13 (2007)[48] reported reported reported reported reported reported0% 43.8% 37.5% 0% 0% 0% Mackenzie GD, et 16 al. (2008)[38] (0/16) (7/16) (6/16) (0/16) (0/16) (0/16)18.8% 68.8% 36.2% 0% 0% 0% Overholt BF, et al. 138 (2007)[49] (26/138) (95/138) (50/138) (0/138) (0/138) (0/138)Not Not Not Not Not Overholt BF, et al. Not 94 (2003)[50] reported reported reported reported reported reported0% 0% 0% 0% 0% 0% Overholt BF, et al. 11 (1997)[51] (0/11) (0/11) (0/11) (0/11) (0/11) (0/11)Not Not Not Not Not Weiss AA, et al. Not 13 (2006)[52] reported reported reported reported reported reportedNot Not Not Not Not Wolfsen HC, et al. Not 69 (2004)[53] reported reported reported reported reported reported0% 0% 13.6% 0% 0% 0% Yachimski P, et al. 59 (2008)[54] (0/59) (0/59) (8/59) (0/59) (0/59) (0/59)6.6% 26.4% 18.5% 0% 0% 0% Pooled total 583 (26/394) (104/394) (73/394) (0/394) (0/394) (0/394) 0-18.8% 0-68.8% 0-37.5%APCComparative studies 4 0% 0% 0% 0% 0% 0% Dulai GS, et al. 26 (2005)[17] (0/26) (0/26) (0/26) (0/26) (0/26) (0/26)0% 0% 7.1% 0% 85.7% 0% Hage M, et al. 14 (2004)[13] (0/14) (0/14) (1/14) (0/14) (12/14) (0/14)2.9% 0% 0% 0% 94.1% 0% Kelty CJ, et al. 37 (2004)[14] (1/34) (0/34) (0/34) (0/34) (32/34) (0/34)0% 0% 23.1% 0% 7.7% 0% Ragunath K, et al. 13 (2005)[15] (0/13) (0/13) (3/13) (0/13) (1/13) (0/13)10.5% 0% 5.3% 0% 0% 0% Sharma P, et al. 19 (2006)[18] (2/19) (0/19) (1/19) (0/19) (0/19) (0/19)Not Not Not Not Not Thomas T, et al. Not 5 (2005)[55] reported reported reported reported reported reported30.0% 0% 0% 0% 0% 0% Zoepf T, et al. 10 (2003)[16] (3/10) (0/10) (0/10) (0/10) (0/10) (0/10)Non-comparative studies0% 0% 0% 3.4% 0% 0% Attwood SE, et al. 29 (2003)[56] (0/29) (0/29) (0/29) (1/29) (0/29) (0/29)Not Not Not Not Not Basu KK (2006) Not 33 [57] reported reported reported reported reported reported0% 0% 0% 0% 91.7% 0% Brand B, et al. 12 (2000)[58] (0/12) (0/12) (0/12) (0/12) (11/12) (0/12)0% 0% 10.0% 0% 0% Bright T, et al. 20 ‘some’ (2007)[59] (0/20) (0/20) (2/20) (0/20) (0/20)100% 0% 0% 0% 0% 0% Dumoulin FL, et 2 al. (1997)[60] (2/2) (0/2) (0/2) (0/2) (0/2) (0/2)0% 0% 0% 0% 0% 0% Familiari L (2003) 32 [61] (0/32) (0/32) (0/32) (0/32) (0/32) (0/32)Not Not Not Not Not Ferraris R, et al. Not 96 (2007)[62] reported reported reported reported reported reported5 4.8% 0% 4.8% 0% 0% 0% Formentini A 21 (2007)[63] (1/21) (0/21) (1/21) (0/21) (0/21) (0/21)0% 0% 0% 0% 11.1% 0% Grade AJ, et al. 9 (1999)[64] (0/9) (0/9) (0/9) (0/9) (1/9) (0/9)0% 0% 4.1% 0% 0% 0% Madisch A, et al. 73 (2005)[65] (0/73) (0/73) (3/73) (0/73) (0/73) (0/73)9.6% 0% 1.0% 0% 0% 0% Manner H, et al. 104 (2007)[66] (10/104) (0/104) (1/104) (0/104) (0/104) (0/104)0% 0% 2.4% 0% 0% 0% Manner H, et al. 41 (2006)[67] (0/41) (0/41) (1/41) (0/41) (0/41) (0/41)3.9% 0% 0% 3.9% 2.0% 3.9% Manner H, et al. 51 (2/51 (2006)[23] (0/51) (0/51) (2/51) (1/51) (2/51) requiring transfusion)0/40 0/40 0/40 0/40 1/40 2/40 sessions 25 sessions Pedrazzani C, et sessions sessions sessions sessions al. (2005)[68] (see note 2 (see note 2 below) (see note 2 (see note 2 (see note 2 (see note 2 below) below) below) below) below)0% 0% 9.1% 0% 54.5% 0% Pereira-Lima JC, 33 et al. (2000)[69] (0/33) (0/33) (3/33) (0/33) (18/33) (0/33)21.1% 0% 0% 0% 21.1% 0% Pinotti AC, et al. 19 (2004)[70] (4/19) (0/19) (0/19) (0/19) (4/19) (0/19)6.7% 0% 3.3% 0% 6.7% 0% Tigges H, et al. 30 (2001)[71] (2/30) (0/30) (1/30) (0/30) (2/30) (0/30)Not Not Not Not Not Van Laethem JL, Not 7 et al. (2001)[72] reported reported reported reported reported reported6.5% 0% 6.5% 0% 6.5% 3.2% Van Laethem JL, 31 et al. (1998)[73] (2/31) (0/31) (2/31) (0/31) (2/31) (1/31)4.3% 0% 3.4% 0.3% 13.6% 0.5%Pooled total 792 (27/623) (0/623) (21/623) (2/623) (85/623) (3/623)0-100% 0-23.1% 0-3.4% 0-94.1% 0-3.9%Cryoablation 6 Comparative studies - noneNon-comparative studiesNot Not Not Not Not Dumot JA, et al. Not 20 (2008)[74] reported reported reported reported reported reported9.1% 0% 0% 0% 0% 0% Johnston MH 11 (2005)[75] (1/11) (0/11) (0/11) (0/11) (0/11) (0/11)9.1% 0% 0% 0% 0% 0% Pooled total 31 (1/11) (0/11) (0/11) (0/11) (0/11) (0/11)Combined EMR & PDTComparative studiesBehrens A, et al. 0% 0% 0% 0% 0% 0% 3 (2005)[25] (0/3) (0/3) (0/3) (0/3) (0/3) (0/3)Non-comparative studiesWolfsen HC, et al. 0% 0% 0% 0% 0% 0% 3 (2004)[76] (0/3) (0/3) (0/3) (0/3) (0/3) (0/3)0% 0% 0% 0% 0% 0% Pooled total 6 (0/6) (0/6) (0/6) (0/6) (0/6) (0/6)ThermocoagulationComparative studies - noneNon-comparative studies0% 0% 0% 0% 0% 0% Michopoulos S, et 13 al. (1999)[77] (0/13) (0/13) (0/13) (0/13) (0/13) (0/13)0% 0% 0% 0% 0% 0% Pooled total 13 (0/13) (0/13) (0/13) (0/13) (0/13) (0/13)EMRComparative studies0% 0% 0% 0% 0% 0% Behrens A, et al. 14 (2005)[25] (0/14) (0/14) (0/14) (0/14) (0/14) (0/14)Reed MF, et al. 5 0% 0% 0% 0% 0% 0% (2005)[20]7 (0/5) (0/5) (0/5) (0/5) (0/5) (0/5)Non-comparative studies0% 0% 0% 0% 0% 25.0% Giovannini M, et 12 al. (2004)[78] (0/12) (0/12) (0/12) (0/12) (0/12) (3/12)Mino-Kenudson Not Not Not Not Not Not M, et al. (2005) 3 reported [79] reported reported reported reported reportedNot Not Not Not Not Seewald S, et al. Not 3 (2003)[80] reported reported reported reported reported reported0% 0% 0% 0% 0% 0% Tang SJ, et al. 1 (2008)[81] (0/1) (0/1) (0/1) (0/1) (0/1) (0/1)9.4% 0% 0% 0% 0% 0% Pooled total 38 (3/32) (0/32) (0/32) (0/32) (0/32) (0/32) 0-25.0%Laser ablationComparative studies - noneNon-comparative studies0% 0% 0% 0% 0% 0% Barham CP, et al. 16 (1997)[82] (0/16) (0/16) (0/16) (0/16) (0/16) (0/16)0% 0% 12.5% 0% 0% 0% Bonavina L, et al. 18 (1999)[83] (0/16) (0/16) (2/16) (0/16) (0/16) (0/16)Not Not Not Not Not Bowers SP, et al. Not 9 (2003) [84] reported reported reported reported reported reportedNot Not Not Not Not Ertan A, et al. Not 1 (1995)[85] reported reported reported reported reported reported4.8% 0% 0% 4.8% 4.8% 0% Fisher RS, et al. 21 (1/21) (2003)[24] (0/21) (0/21) (1/21) (1/21) (0/21) required transfusion0% 0% 0% 0% 0% 0% Norberto L, et al. 15 (2004)[86] (0/15) (0/15) (0/15) (0/15) (0/15) (0/15)Salo JA, et al. 11 Not Not Not Not Not Not (1998)[87] 8 reported reported reported reported reported reported4.4% 1.5% 1.5% 0% 0% 0% Pooled total 91 (3/68) (1/68) (1/68) (0/68) (0/68) (0/68) 0-12.5% 0-4.8% 0-4.8%MPECComparative studies0% 0% 0% 0% 0% 0% Dulai GS, et al. 26 (2005)[17] (0/26) (0/26) (0/26) (0/26) (0/26) (0/26)31.3% 0% 0% 0% 0% 0% Sharma P, et al. 16 (2006)[18] (5/16) (0/16) (0/16) (0/16) (0/16) (0/16)Non-comparative studiesNot Not Not Not Not Faigel DO, et al. Not 25 (2002)[88] reported reported reported reported reported reported40.7% 0% 3.7% 0% 40.7% 0% Kovacs BJ, et al. 27 (1999)[89] (11/27) (0/27) (1/27) (0/27) (11/27) (0/27)7.1% 0% 0% 0% 14.3% 0% Montes CG, et al. 14 (1999)[90] (1/14) (0/14) (0/14) (0/14) (2/14) (0/14)10.0% 0% 0% 0% 20.0% 10.0% Sampliner RE, et 10 al. (1996)[91] (1/10) (0/10) (0/10) (0/10) (2/10) (1/10)63.6% 0% 0% 0% 0% 0% Sampliner RE 11 (1999)[92] (7/11) (0/11) (0/11) (0/11) (0/11) (0/11)24.0% 1.0% 1.0% 14.4% 0% 0% (15/104) Pooled total 129 (25/104) (1/104) (1/104) (0/104) (0/104) 0-40.7% 0-63.6% 0-3.7% 0-10.0%RFAComparative studiesNot Not Not Not Not Bumgarner JM, et Not 103 al. (2008)[93] reported reported reported reported reported reported0% 0% 6.0% 0% 0% 1.2% Shaheen NJ, et al. 84 (2009)[19] (0/84) (0/84) (5/84) (0/84) (0/84) (1/84)9 (see note 4 below)Non-comparative studies0% 0% 0% 0% 0% 0% Eldaif SM, et al. 27 (2009)[94] (0/27) (0/27) (0/27) (0/27) (0/27) (0/27)70 Fleischer DE, et 0% 0% 0% 0% 0% 1.4% al. (2008)[95] (after 1.5 sessions (0/70) (0/70) (0/70) (0/70) (0/70) (1/70) /patient)0% 0% 0.7% 0% 0% 0% Ganz RA, et al. 142 (2008)[96] (0/142) (0/142) (1/142) (0/142) (0/142) (0/142)0% 0% 0% 0% 0% 0% Hernandez JC, et 10 al. (2008)[97] (0/10) (0/10) (0/10) (0/10) (0/10) (0/10)Hubbard N & Not Not Not Not Not Not Velanovich V 7 reported (2007)[98] reported reported reported reported reported9.1% 0% 0% 0% 0% 0% Pouw RE, et al. 44 (2008)[99] (4/44) (0/44) (0/44) (0/44) (0/44) (0/44)23.1% 0% 0% 0% 23.1% 0% Roorda AK, et al. 13 (2007)[99] (3/13) (0/13) (0/13) (0/13) (3/13) (0/13)0% 0% 0% 0% 0% 0% Sharma VK, et al. 32 (2007)[101] (0/32) (0/32) (0/32) (0/32) (0/32) (0/32)Not Not Not Not Not Smith CD, et al. Not 5 (2007)[102] reported reported reported reported reported reported0% 0% 1.6% 0% 0% 1.6% Sharma VK, et al. 63 (2009)[103] (0/63) (0/63) (1/63) (0/63) (0/63) (1/63)0/59 0/59 2/59 0/59 0/59 1/59 ablations ablations ablations ablations ablations Vassiliou MC, et ablations 25 al. (2009)[104] (see note 5 (see note 5 (see note 5 (see note 5 (see note 5 (see note 5 below) below) below) below) below) below)0% 0% 6.1% 0% 0% 0% Velanovich V 66 (2009)[105] (0/66) (0/66) (4/66) (0/66) (0/66) (0/66)Gondrie JJ, et al. 11 0% 0% 0% 0% 0% 0% (2008)[106] 10 (0/11) (0/11) (0/11) (0/11) (0/11) (0/11)8.3% 0% 0% 0% 0% 0% Gondrie JJ, et al. 12 (2008)[21] (1/12) (0/12) (0/12) (0/12) (0/12) (0/12)1.4% 1.9% 0.5% 0.5% 0% 0% Pooled total 714 (8/574) (11/574) (3/574) (3/574) (0/574) (0/574) 0-23.1% 0-6.1% 0-23.1% 0-1.6%Notes: (1) ALA (aminolevulinic acid), APC (argon plasma coagulation), EMR (endoscopic mucosal resection), GI (gastrointestinal), HpD (hematoporphyrin derivative), MPEC (multipolar electrocoagulation), mTHPC (meta- tetrahydroxyphenylchlorin), PDT (photodynamic therapy), RFA (radiofrequency ablation) (2) As these numbers are rates per number of sessions, they have not been included in the pooled totals. (3) As a single case of a gastrointestinal bleed reported in the MacKenzie G et al (2005) study cannot be definitely attributed to the 30 mg/kg ALA treatment or the 60 mg/kg ALA treatment, it has not been included in the pooled totals. (4) Possibly or probably related to RFA (5) As these numbers are rates per number of ablations, they have not been included in the pooled totals. (6) *Photosen. (photosensitivity), Perfor. (perforation), Odynoph. (odynophagia), Bleed. (bleeding), ** - (not available) 11

Additional File 9 - Studies of Adverse Events (Endoscopic Treatments)

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