1.1 The evidence on efficacy of endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) of non-ampullary duodenal lesions is limited in quantity and there are safety concerns regarding the risks of perforation and bleeding. Therefore these procedures should only be used with special arrangements for clinical governance, consent and audit or research.
1.2 Clinicians wishing to undertake EMR and ESD of non-ampullary duodenal lesions should take the following actions.
Inform the clinical governance leads in their Trusts.
Ensure that patients understand the uncertainty about these procedures' safety and efficacy in relation to the risks of perforation and bleeding, and that conversion to open surgery may be necessary. Patients should be provided with clear written information. In addition, the use of NICE's information for patients ('Understanding NICE guidance') is recommended.
Audit and review clinical outcomes of all patients having EMR and ESD of non-ampullary duodenal lesions (see section 3.1).
1.3 Patient selection should be carried out by an upper gastrointestinal cancer multidisciplinary team.
1.4 Both EMR and ESD of non-ampullary duodenal lesions are technically challenging procedures and should be carried out only by clinicians with specific training and expertise in the use of EMR and ESD in other parts of the gastrointestinal tract (where lesions are more common). The Joint Advisory Group on Gastrointestinal Endoscopy intends to prepare training standards on these procedures.
1.5 NICE encourages further research into EMR and ESD of non-ampullary duodenal lesions. There should be clear documentation of the incidence of complications, including perforation, bleeding and the need for open surgery (with the reasons for this), rates of complete resection, and long-term outcomes, including local recurrence and survival following treatment of malignant lesions.