2 The procedure
2.1.1 Duodenal lesions (benign, dysplastic or neoplastic) are rare. Symptoms include nausea and vomiting, loss of appetite and weight, anaemia and abdominal pain. Lesions in people who have inherited polyposis syndromes may be identified through regular surveillance examinations.
2.1.2 Current treatment of malignant lesions may require major surgery (Whipple procedure). Endoscopic treatments such as snare polypectomy and argon plasma coagulation (APC) have been used for smaller lesions.
2.2.1 Both procedures aim to remove lesions without the need for open abdominal surgery. They are usually preceded by diagnostic endoscopy, biopsy and imaging investigations.
2.2.2 Both EMR and ESD are carried out with the patient under sedation or general anaesthesia. Using endoscopic visualisation, the submucosa is injected with saline to help lift the lesion. This fluid may contain pigment to help define the lesion, and adrenaline to reduce bleeding. In EMR, lesions are usually removed piecemeal with a snare. In ESD, submucosal dissection is performed with an electrocautery knife, parallel to the muscle layer, aiming to remove the lesion intact and with clear margins. A transparent hood may be used to retract the already dissected part of the lesion out of the visual field. Haemostasis is achieved by electrocautery. Endoscopic clips may be used for larger vessels or to manage perforation.
Sections 2.3 and 2.4 describe efficacy and safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview.
2.3.1 Case series of 27 and 23 patients reported complete resection in 85% (23/27) and 86% (18/21) of EMR-treated patients respectively. A case series of 14 patients reported that all 9 ESD-treated lesions were resected en bloc and 5 of the 6 EMR-treated lesions were resected en bloc.
2.3.2 The case series of 23 patients (21 EMR-treated patients) reported no local recurrences among 8 lesions removed en bloc at a median 13-month follow-up. Among 13 lesions removed piecemeal, 38% (5/13) of lesions had remnant adenoma at a median follow-up of 10 months; all were treated successfully with snare resection and/or APC.
2.3.3 Case series of 13 EMR-treated patients, 4 ESD-treated patients and 3 EMR-treated patients reported no deaths or recurrences at mean follow-up of between 18 and 51.7 months.
2.3.4 The Specialist Advisers listed key efficacy outcomes as complete removal and recurrence rates, recovery period and mortality.
2.4.1 Perforation was reported in 2 ESD-treated patients and another 2 ESD-treated patients (successfully managed conservatively) in case series of 14 and 4 patients respectively.
2.4.2 Bleeding was reported in 33% (9/27) of patients in the case series of 27 EMR-treated patients (within a larger series of 92 patients treated with EMR of different gastrointestinal organs). Among the 92 patients, 22 developed bleeding, 73% (16/22) of whom developed it early (within 24 hours of EMR treatment). Among those who bled early, 88% (14/16) were treated with endoscopic clip placement, snare ligation, electrocoagulation and/or injection therapy; 2 of the 6 patients who bled later than 24 hours required endoscopic management. Blood transfusion was required in 14% (3/22) of patients.
2.4.3 Post-procedural bleeding was reported in 2 of 9 ESD-treated patients and 1 of 5 EMR-treated patients in the case series of 14 patients; all were successfully treated using endoscopic clips. The case series of 23 and 13 patients reported that 1 patient in each series developed bleeding after EMR (1 occurred up to 48 hours after EMR); both were successfully treated using endoscopic clips.
2.4.4 The Specialist Advisers considered theoretical adverse events to include delayed haemorrhage, perforation, bleeding and pain. They stated that the risks of perforation and bleeding are higher when these procedures are used in the duodenum than in other parts of the gastrointestinal tract.