Journal List > Korean J Gastroenterol > v.67(2) > 1007536

Jung, Kim, Lee, Jang, and Kim: Comparison on Oral versus Intravenous Proton Pump Inhibitors for Prevention of Bleeding after Endoscopic Submucosal Dissection of Gastric Lesions

Abstract

Background/Aims

Although intravenous proton pump inhibitor (PPI) has been used for the prevention of post endoscopic submucosal dissection (ESD) bleeding, the route of administration has not been confirmed. The aim of the present study was to compare the efficacy of intravenous and oral PPI administration for the prevention of delayed post ESD bleeding.

Methods

Total 166 consecutive patients were randomly assigned to 30 mg lansoprazol twice a day (PO group) and 120 mg pantoprazole intravenous injection (IV group) for 48 hours. Finally, 65 patients in PO group and 87 patients in IV group were analyzed. After ESD, all patients underwent follow up endoscopy after 24 hours and were observed the symptoms of bleeding up to 60 days after ESD.

Results

Age, sex and use of anticoagulants were not different between groups. At follow up endoscopy after 24 hours, oozing and exposed vessel was noted in 4.6% of PO group and 8.0% of IV group and there was no significant difference. Delayed bleeding occurred in 4 of 65 patients (6.2%) in the PO group and 8 of 87 patients (9.2%) in the IV group (p>0.999). By multivariate analysis, oozing or exposed vessels at follow up endoscopy were risk factors for delayed bleeding (OR=17.5, p=0.022).

Conclusions

There was no significant difference in the delayed bleeding, length of hospital stay according to the administration route. Bleeding stigmata at follow up endoscopy was risk factor of delayed bleeding. Oral PPI administration can cost-effectively replace IV PPI for prevention of post ESD bleeding.

References

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Fig. 1.
Treatment protocol of the groups. POD, post-operative day; PO, per oral; IV, intravenous; ESD, endoscopic submucosal dissection; bid, twice a day; qd, once a day.
kjg-67-74f1.tif
Fig. 2.
Flow chart of study participants. PO, per oral; IV, intravenous; PPI, proton pump inhibitor; f/u, follow up.
kjg-67-74f2.tif
Table 1.
Baseline Characteristics of 151 Analyzed Patients
  PO group (n=65) IV group (n=87) p-value
Age (yr) 62.0±8.8 62.6±9.6 0.702
Male 45 (69.2) 64 (73.6) 0.557
Laboratory findings      
  Hemoglobin (g/dL) 13.2±1.5 13.5±1.5 0.181
  BUN (mg/dL) 15.1±5.2 14.9±6.0 0.884
  Creatinine (mg/dL) 1.5±5.2 0.9±0.7 0.272
Underlying disease 36 (55.4) 36 (41.4) 0.087
  Diabetes mellitus 10 (15.4) 8 (9.2) 0.243
  Hypertension 24 (36.9) 26 (29.9) 0.361
  Cerebro-cardiovascular 8 (12.3) 2 (2.3) 0.019
  Others* 6 (9.2) 7 (8.0) 0.796
Anticoagulation 15 (23.1) 13 (14.9) 0.201
  Warfarin 0 (0) 0 (0)
  Aspirin 14 (21.5) 13 (14.9) 0.293
  Clopidogrel 2 (3.1) 2 (2.3) >0.999
  Cilostazole 1 (1.5) 0 0.428
  Discontinuation period (day) 9.1±6.2 7.5±1.7 0.352

Values are presented as mean±SD or n (%).

PO, per oral; IV, intravenous.

*Malignancy (breast, thyroid, brain), chronic hepatitis B, benign prostate hypertrophy.

Table 2.
Endoscopic and Microscopic Findings of the Lesion
  PO group (n=65) IV group (n=87) p-value
Location (long axis)     0.340
  Antrum 37 (56.9) 56 (64.4)  
  Angle 8 (12.3) 14 (16.1)  
  Proximal body 4 (6.2) 4 (4.6)  
  Mid body 4 (6.2) 2 (2.3)  
  Distal body 8 (12.3) 8 (9.2)  
  Fundus/cardia 1 (1.5) 3 (3.4)  
  Pylorus 3 (4.6) 0 (0)  
Location (short axis)     0.502
  Anterior wall 8 (12.3) 9 (10.3)  
  Posterior wall 15 (23.1) 18 (20.7)  
  Lesser curvature 29 (44.6) 33 (37.9)  
  Great curvature 13 (20.0) 27 (31.0)  
Resection style     >0.999
  En bloc 63 (96.9) 83 (95.4)  
  Piecemeal 2 (3.1) 4 (4.6)  
Pathologic sample size (cm2) 7.0±5.0 6.5±4.0 0.425
Microscopic findings     0.077
  Tubular adenoma 30 (46.2) 30 (34.5)  
  High grade dysplasia 2 (3.1) 11 (12.6)  
  AdenoCa WD 24 (36.9) 29 (33.3)  
  AdenoCa MD 8 (12.3) 10 (11.5)  
  Gastritis 1 (1.5) 7 (8.0)  
Follow up GFS     0.292
  Clean ulcer 23 (35.4) 21 (24.1)  
  Spurting 0 (0) 0 (0)  
  Oozing 2 (3.1) 7 (8.0)  
  Exposed vessel 1 (1.5) 0 (0)  
  Adherent clot 8 (12.3) 11 (12.6)  
  Red spot 31 (47.7) 48 (55.2)  
Stigmata at follow up GFS 3 (4.6) 7 (8.0) 0.517

Values are presented as n (%) or mean±SD.

PO, per oral; IV, intravenous; AdenoCa, adenocarcinoma; WD, well differentiated; MD, moderate differentiated; GFS, gastrofiberscopy.

Table 3.
Comparison of Bleeding after Endoscopic Submucosal Dissection
  PO group IV group p-value
Bleeding during procedure 14 (21.5) 13 (14.9) 0.293
Delayed bleeding 4 (6.2) 8 (9.2) 0.558
  Symptomatic bleeding 2 (3.1) 3 (3.4) >0.999
  Non-symptomatic bleeding 2 (3.1) 5 (5.7) 0.699
Onset of delayed bleeding (hr)     0.236
  Within 24 2 (50) 7 (87.5)  
  24–72 0 (0) 0 (0)  
  Over 72 2 (50) 1 (12.5)  
Mortality 0 (0) 0 (0)
Hospital stay (day) 4.5±0.8 4.6±1.3 0.445

Values are presented as n (%) or mean±SD.

PO, per oral; IV, intravenous.

Table 4.
Comparisons between Rebleeding Group and Nonbleeding Group
  Rebleeding (n=12) Nonbleeding (n=140) p-value
Operator (A/B/C/D) 6/0/3/3 40/3/78/19 0.180
Size of lesion (cm2) 6.98±3.28 6.68±4.55 0.827
PPI administration route (PO/IV) 4/8 61/79 0.558
Hospital stay (day) 5.8±1.7 4.5±1.0 0.010

Values are presented as n only or mean±SD.

PO, per oral; IV, intravenous.

Table 5.
Risk Factors Associated with Post ESD Symptomatic Bleeding (n=5)
  B p-value OR (95% CI)
Endoscopic stigma 3.401 0.001 30.000 (4.296–209.508)
Malignant pathologic findings 0.085 0.936 0.919 (0.117–7.222)
Size of lesion 0.165 0.575 1.179 (0.663–2.095)
Location of lesion 0.358 0.565 1.431 (0.423–4.842)
PPI administration route −0.004 0.997 0.996 (0.114–8.702)

Statistics were analyzed by backward stepwise method in logistic regression analysis.

ESD, endoscopic submucosal dissection; B, regression coefficient; PPI, proton pump inhibitor.

Table 6.
Risk Factors Associated with Post ESD Symptomatic Bleeding after 24 Hours (n=3)
  B p-value OR (95% CI)
Endoscopic stigma 2.303 0.073 10 (0.807–123.990)
Malignant pathologic findings 0.370 0.780 1.447 (0.108–19.456)
Size of lesion 0.131 0.679 1.140 (0.613–2.121)
Location of lesion 0.667 0.321 1.949 (0.521–7.294)
PPI administration route −0.887 0.491 0.412 (0.033–5.145)

Statistics were analyzed by backward stepwise method in logistic regression analysis.

ESD, endoscopic submucosal dissection; B, regression coefficient; PPI, proton pump inhibitor.

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