Intraoperative distensibility measurement in POEM for achalasia: impact on patient outcome and associations with other outcome variables at 1-year follow-up.

BACKGROUND AND AIMS: The functional luminal imaging probe (FLIP) can provide measurements of lower esophageal sphincter (LES) distensibility. Studies report that use of intraoperative FLIP examination during peroral endoscopic myotomy (POEM) for achalasia is associated with treatment success, but evidence is limited and inconsistent. The main aim of the present study was to assess associations between intraoperative FLIP values and 1-year outcomes. Additionally, associations between 1-year FLIP measurements and other 1-year outcome variables were studied. METHODS: We performed a single-center prospective study of consecutive achalasia patients treated with POEM with a standardized 1-year follow-up. The inclusion period was from June 2017 to January 2020. We compared 1-year outcomes (FLIP measurement values, Eckardt score (ES), reflux esophagitis, timed barium esophagogram (TBE), and lower esophageal sphincter resting pressure (LES-rp)) in patients with and without intraoperative FLIP examination. We also assessed associations between intraoperative FLIP values, 1-year FLIP values, and other 1-year outcomes. Results are given as median (IQR), and non-parametrical statistical analyses were applied. RESULTS: Sixty-two patients (27 females) with median age 45 years (35-54) were included. Baseline characteristics were similar in patients with (n = 32) and without (n = 30) intraoperative FLIP examination. In patients with intraoperative FLIP, ES was 2 (1-3) and LES distensibility index (DI) 3.7 (2.6-5.4) after 1 year, compared with ES 2 (1-3) and DI 4.0 (3.1-6.8)) in patients without intraoperative FLIP (ns). Intraoperative DI was not correlated with 1-year ES or DI. One-year DI correlated significantly with 1-year ES (rs - 0.42), TBE (rs - 0.34), and LES-rp (rs - 0.29). CONCLUSIONS: Use of intraoperative FLIP measurements in POEM for achalasia is not associated with improved 1-year outcome, and the clinical value of intraoperative FLIP in POEM for achalasia is questioned. Follow-up FLIP measurements are moderately associated with symptomatic outcome, and may serve as an additional diagnostic modality in post-treatment evaluation.

Quality of life in patients with achalasia: Associations with Eckardt score and objective treatment outcomes after peroral endoscopic myotomy.

Background and study aims Knowledge on self-reported quality of life (QoL) in achalasia and QoL improvements after peroral endoscopic myotomy (POEM) is limited. Furthermore, the clinical role of QoL in achalasia follow-up has not been evaluated. The present study aimed to examine QoL in achalasia patients before and after POEM and assess associations between QoL, Eckardt score (ES) and objective results. Patients and methods This was a single-center prospective study of treatment-naïve achalasia patients with 12-month follow-up after POEM including manometry, upper endoscopy, 24-hour pH registration, and timed barium esophagogram. QoL data were registered using European Organisation for Research and Treatment of Cancer core questionnaire (QLQ-C30) and esophageal module (QLQ-OES18). Comparison with a reference population was performed to assess impact of achalasia on QoL and effect of therapy. Mixed models for repeated measures were applied. Results Fifty patients (26 females) with a median age of 47 years (18-76) were included. Before treatment, all QoL domains were significantly impaired compared with an age- and gender-adjusted reference population ( P  < 0.05). No significant QoL-differences were found after POEM, except for fatigue and nausea/vomiting. Clinically relevant QoL improvement was observed in ≥ 50 % of the patients in all QoL domains, except for physical and role functioning. QoL was significantly associated with ES ( P  < 0.05) but not with objective results. Conclusions Achalasia is associated with severe QoL impairment. Following POEM, a significant and clinically relevant QoL improvement is observed. QoL is associated with ES, but not with objective results after POEM.

One year comprehensive prospective follow-up of achalasia patients after peroral endoscopic myotomy.

BACKGROUND AND AIMS: Peroral endoscopic myotomy (POEM) is an established therapy for achalasia, but outcome evaluation has often been limited to Eckardt score (ES). The present study was aimed to improve knowledge about outcome evaluation and predictive outcome factors by performing a comprehensive objective evaluation of achalasia patients treated by POEM. METHODS: This single centre prospective study reports outcome data 12 months after POEM in treatment-naive achalasia patients. A predefined follow-up protocol included ES, high resolution manometry, 24-h pH measurement, upper endoscopy and timed barium esophagogram (TBE). Univariate and multivariate regression analyses were performed to analyze association between post-POEM variables and identify predictive factors for objective outcome. RESULTS: Fifty patients were included with a drop-out rate of <5%. ES, lower oesophageal sphincter pressures, TBE heights and maximal oesophageal diameter were all reduced after POEM (p < .001), and 28% (13/47) of the patients had a positive 24-h pH registration. An oesophageal diameter >3 cm after POEM was associated with treatment failure assessed by ES (p = .04) and TBE (p = .03). Advanced achalasia stage (p = .02) and long symptom duration (p = .04) were identified as independent predictive factors for poor outcome assessed by TBE. CONCLUSIONS: The present study confirms that POEM is an efficient therapy for achalasia. The comprehensive objective evaluation after POEM demonstrates that long symptom duration and major changes in oesophageal anatomy at diagnosis imply poor treatment outcome, and a post-POEM dilated oesophagus is associated with treatment failure.Key messagesPeroral endoscopic myotomy (POEM) is established as a safe and effective therapy for achalasia.Timed barium esophagogram offers objective variables that are valuable in treatment response evaluation. Advanced achalasia stage and long symptom duration are predictive factors for poor objective treatment response after POEM.

Outcome of peroral endoscopic myotomy (POEM) in treatment-naive patients. A systematic review.

OBJECTIVES: Achalasia is a primary motility disorder of the esophagus characterized by aperistalsis and failure of lower esophageal sphincter (LES) relaxation. Treatment of achalasia aims at reducing LES pressure. The common treatment modalities are laparoscopic Heller myotomy and pneumatic dilatation, but during the last decade, a promising treatment, per oral endoscopic myotomy (POEM), has been introduced. The aim of the present study was to perform a systematic review of the literature to assess the outcome of POEM in treatment-naive patients. MATERIALS AND METHODS: A systematic literature search in PubMed, Embase and Cochrane databases was performed using the terms 'Achalasia AND (POEM OR peroral endoscopic myotomy OR per-oral endoscopic myotomy)'. Inclusion criteria were: original article; English language; n ≥ 20 with ≥90% treatment-naive patients; follow-up ≥3 months; and outcome evaluation of POEM including symptom score and objective tests. Exclusion criteria were: reviews and meta-analyses; pediatric data; duplicates; and articles with overlapping data material. RESULTS: Of the 1641 articles identified, seven were included. The included studies all reported a short-term clinical success of >90%. Clinical success including post-POEM reflux was mainly estimated by symptom scorings. There were few procedure-related complications. CONCLUSIONS: The studies of treatment-naive patients indicate a high rate of clinical success. Nevertheless, a more systematic and standardized evaluation is recommended to improve the reports on outcome of POEM. The follow-up rate should be high and the evaluation protocol should include both symptom scoring and objective testing with predefined treatment goals.

Long-term outcome of palliative treatment with self-expanding metal stents for malignant obstructions of the GI tract.

BACKGROUND: Self-expanding metal stents (SEMS) are commonly used in the palliative treatment of malignant gastrointestinal (GI) obstructions with favorable short-term outcome. Data on long-term outcome are scarce, however. AIM: To evaluate long-term outcome after palliative stent treatment of malignant GI obstruction. METHOD: Between October 2006 and April 2008, nine Norwegian hospitals included patients treated with SEMS for malignant esophageal, gastroduodenal, biliary, and colonic obstructions. Patients were followed for at least 6 months with respect to stent patency, reinterventions, and readmissions. RESULTS: Stent placement was technically successful in 229 of 231 (99%) and clinically successful after 1 week in 220 of 229 (96%) patients. Long-term follow-up was available for 219 patients. Of those, 72 (33%) needed reinterventions. Stent occlusions or migrations (92%) were the most common reasons. Esophageal stents required reinterventions most frequently (41%), and had a significantly (p = 0.02) shorter patency (median 152 days) compared to other locations (gastroduodenal, 256 days; colon, 276 days; biliary, 460 days). Eighty percent of reinterventions were repeated endoscopic procedures that successfully restored patency. Readmissions were required for 156 (72%) patients. Progression of the underlying cancer was the most common reason, whereas 24% were readmitted due to stent complications. CONCLUSIONS: Long-term outcome after palliative treatment with SEMS for malignant GI and biliary obstruction shows that 70% had a patent stent until death, and that most reobstructions could be solved endoscopically. Hospital readmissions were mainly related to progression of the underlying cancer disease.

Stent treatment of malignant gastric outlet obstruction: the effect on rate of gastric emptying, symptoms, and survival.

BACKGROUND: Advanced pancreatic cancer and other malignancies located proximal to the small bowel might cause gastric outlet obstruction (GOO) resulting in nausea, vomiting, dehydration, and malnutrition. Self-expandable metal stents (SEMS) to a large extent have replaced surgical treatment, with gastro-entero-anastomosis as palliative treatment for GOO. The aim of the present study was to evaluate the effect of duodenal stenting on the rate of gastric emptying, symptoms, and survival. METHODS: Patients with endoscopically verified malignant obstruction of the proximal duodenum were included. Gastric emptying rate was measured prior to and within 1 week after stent placement using a meal containing (13)C-octanoic acid as a marker. Symptoms related to GOO were assessed by the patients before and 2 weeks after stent treatment and during the gastric emptying tests. All patients were followed up until death. RESULTS: In the patients included (n = 17), all studied variables of gastric emptying improved significantly following treatment, and a reduction in self-reported obstructive symptoms was observed. There was no correlation between survival and the rate of gastric emptying before or after, or the change in the rate of emptying. CONCLUSION: The present study demonstrated that treatment with SEMS results in improved gastric emptying in most patients with GOO and a corresponding reduction in self-reported obstruction symptoms. However, survival and emptying were not related. The present findings provide further evidence that treatment with stents is an effective palliative treatment in patients with GOO.

Patient-reported outcomes in palliative gastrointestinal stenting: a Norwegian multicenter study.

BACKGROUND: The clinical effect of stent treatment has been evaluated by mainly physicians; only a limited number of prospective studies have used patient-reported outcomes for this purpose. The aim of this work was to study the clinical effect of self-expanding metal stents in treatment of malignant gastrointestinal obstructions, as evaluated by patient-reported outcomes, and compare the rating of the treatment effect by patients and physicians. METHODS: Between November 2006 and April 2008, 273 patients treated with SEMS for malignant GI and biliary obstructions were recruited from nine Norwegian hospitals. Patients and physicians assessed symptoms independently at the time of treatment and after 2 weeks using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire supplemented with specific questions related to obstruction. RESULTS: A total of 162 patients (99 males; median age = 72 years) completed both assessments and were included in the study. A significant improvement in the mean global health score was observed after 2 weeks (from 9 to 18 on a 0-100 scale, P < 0.03) for all stent locations. Both patients and physicians reported a significant reduction in all obstruction-related symptoms (>20 on the 0-100 scale, P < 0.006) after SEMS treatment. The physicians reported a larger mean improvement in symptoms than did the patients, mainly because they reported more severe symptoms before treatment. CONCLUSION: SEMS treatment is effective in relieving symptoms of malignant GI and biliary obstruction, as reported by patients and physicians. The physicians, however, reported a larger reduction in obstructive symptoms than did the patients. A prospective assessment of patient-reported outcomes is important in evaluating SEMS treatment.

Treatment of malignant gastric outlet obstruction with stents: an evaluation of the reported variables for clinical outcome.

BACKGROUND: Malignant gastric outlet obstruction (GOO) is commonly seen in patients with advanced gastric-, pancreatic-, duodenal, hepatobiliary or metastatic malignancies. Ten to 25% of patients with pancreatic cancer will develop duodenal obstruction during the course of the disease. Duodenal stenting with self-expandable metal stents is an alternative treatment to surgical bypass procedures. Our aim was to review the published literature regarding treatment of malignant GOO with stents to reveal whether the information provided is sufficient to evaluate the clinical effects of this treatment METHODS: A literature search from 2000-2007 was conducted in Pub Med, Embase, and Cochrane library, combining the following search terms: duodenal stent, malignant duodenal obstruction, gastric outlet obstruction, SEMS, and gastroenteroanastomosis. All publications presenting data with > or = 15 patients and only articles written in English were included and a review focusing on the following parameters were conducted: 1) The use of graded scoring systems evaluating clinical success; 2) Assessment of Quality of life (QoL) before and after treatment; 3) Information on stent-patency; 4) The use of objective criteria to evaluate the stent effect. RESULTS: 41 original papers in English were found; no RCT's. 16 out of 41 studies used some sort of graded scoring system. No studies had objectively evaluated QoL before or after stent treatment, using standardized QoL-questionnaires, 32/41 studies reported on stent patency and 9/41 performed an oral contrast examination after stent placement. Objective quantitative tests of gastric emptying had not been performed. CONCLUSION: Available reports do not provide sufficient relevant information of the clinical outcome of duodenal stenting. In future studies, these relevant issues should be addressed to allow improved evaluation of the effect of stent treatment.

Transcatheter arterial embolization in the management of bleeding duodenal ulcers: a 5.5-year retrospective study of treatment and outcome.

OBJECTIVE: The mortality rate associated with bleeding duodenal ulcer disease is about 10%. Primary endoscopic hemostasis is successful in over 90% of patients, but in 15-25%, the bleeding cannot be controlled endoscopically or the patient rebleeding, requiring alternative treatment. Percutaneous transcatheter arterial embolization (TAE) has been proposed as an alternative to surgery and was introduced at Ullevål University Hospital in Oslo, Norway, in June 2000. In this study we report our experiences in 36 patients. MATERIAL AND METHODS: A retrospective review identified all patients admitted to Ullevål University Hospital with hematemesis and/or melena and endoscopically verified duodenal ulcer from June 2000 to 2005. The indication for TAE was endoscopically unmanageable bleeding/rebleeding or rebleeding after surgery. Technical success was defined as acute hemostasis. Clinical success was defined as technical success without rebleeding within 30 days. RESULTS: A total of 278 patients (mean age 73 years) were included in the study. Primary endoscopic hemostasis failed in 13 patients (5%) and 53 patients (20%) experienced rebleeding. An attempt was made to treat 36 patients with TAE. Technical success in the TAE group was 92% and clinical success was 72%. In total, 10 patients underwent surgery, 3 because of rebleeding after TAE. The 30-day mortality was 10% for all patients, 19% in the TAE group, and 20% in the surgical group. CONCLUSIONS: High technical and clinical success was obtained with TAE in patients with bleeding duodenal ulcer after failure of endoscopic treatment. TAE appears to be a treatment alternative to surgery in this group of patients.