Background: Endoscopic resection with the submucosal saline injection technique has been used to treat early duodenal cancers and adenomas. However, indications for endoscopic treatment of these cancers have not been established. Methods: We used the submucosal saline injection method to treat 14 early duodenal cancers and adenomas to evaluate its safety and effectiveness. A 0.9% NaCl solution was injected into the submucosal layer near the tumor through needle forceps to elevate the tumor, which was then resected with electrocoagulation. Resected specimens were examined to assess depth of involvement, completeness of resection, and histologic type. Reports of early duodenal cancers in the Japanese literature were reviewed to analyze the relationship among lymph node metastasis, submucosal invasion, and tumor size. Results: All tumors were completely removed “en bloc” (12 tumors) or in a “piecemeal” fashion (two tumors). The largest tumor was 20 mm in diameter. No serious complications occurred during or after treatment. Review of Japanese literature showed that lymph node metastasis did not occur when protruding or elevated tumors were less than 50 mm in diameter but did occur when depressed tumors, with or without marginal elevation, were more than 10 mm in diameter. Conclusions: Endoscopic resection with the submucosal saline injection technique is a safe and effective treatment for early duodenal cancers and adenomas. Protruding or elevated tumors less than 50 mm in diameter can be removed completely. However, because of possible lymph node metastasis, depressed tumors with or without marginal elevation should be removed surgically. (Gastrointest Endosc 1997;46:507-13.)