早期手術與內鏡優先入路相比顯著減輕慢性胰腺炎患者的疼痛
作者:
小柯機器人發布時間:2020/1/23 10:24:05
荷蘭阿姆斯特丹大學的Marja A. Boermeester研究小組取得一項新突破。他們比較了早期手術與內鏡優先入路對慢性胰腺炎患者疼痛的影響。該項研究成果發表在2020年1月21日出版的《美國醫學會雜誌》上。
對於疼痛性慢性胰腺炎患者,往往在內科和內鏡治療失敗後,才會進行手術治療。而觀察性研究表明,早期手術可以緩解疾病進展,減輕疼痛,並保持胰腺功能。
為了探討早期手術是否比內鏡優先入路更有效,2011年4月至2016年9月,研究組進行了一項非盲、多中心、隨機的臨床優勢試驗,在荷蘭30家醫院招募了88名慢性胰腺炎患者,均伴有胰腺主管擴張,近期才開始使用阿片類藥物鎮痛。
將其隨機分組,其中44名接受早期手術,6周內行胰管引流術;44名行內窺鏡優先入路,接受內科治療,內窺鏡檢查並碎石,必要時手術。根據lzbicki疼痛評分對疼痛程度進行評估,0-100分,分數越高越疼痛。研究隨訪至2018年3月。
88例患者的平均年齡為52歲,女性佔24%,共有85例患者完成了試驗。在18個月的隨訪中,早期手術組患者的lzbicki疼痛評分為37分,顯著低於內窺鏡優先入路組(49分)。隨訪結束時,早期手術組中有58%的患者疼痛完全或部分緩解,內窺鏡優先入路組為39%,差異不顯著。早期手術組的幹預總次數顯著低於內窺鏡優先入路組。兩組間的併發症、死亡率、住院率、胰腺功能和生活質量均無顯著差異。
總之,對於慢性胰腺炎患者,早期手術與內鏡優先入路相比,治療18個月後疼痛評分顯著降低。仍需進一步研究來評估長期結局。
附:英文原文
Title: Effect of Early Surgery vs Endoscopy-First Approach on Pain in Patients With Chronic Pancreatitis: The ESCAPE Randomized Clinical Trial
Author: Yama Issa, Marinus A. Kempeneers, Marco J. Bruno, Paul Fockens, Jan-Werner Poley, Usama Ahmed Ali, Thomas L. Bollen, Olivier R. Busch, Cees H. Dejong, Peter van Duijvendijk, Hendrik M. van Dullemen, Casper H. van Eijck, Harry van Goor, Muhammed Hadithi, Jan-Willem Haveman, Yolande Keulemans, Vincent B. Nieuwenhuijs, Alexander C. Poen, Erik A. Rauws, Adriaan C. Tan, Willem Thijs, Robin Timmer, Ben J. Witteman, Marc G. Besselink, Jeanin E. van Hooft, Hjalmar C. van Santvoort, Marcel G. Dijkgraaf, Marja A. Boermeester
Issue&Volume: 2020/01/21
Abstract:
Importance For patients with painful chronic pancreatitis, surgical treatment is postponed until medical and endoscopic treatment have failed. Observational studies have suggested that earlier surgery could mitigate disease progression, providing better pain control and preserving pancreatic function.
Objective To determine whether early surgery is more effective than the endoscopy-first approach in terms of clinical outcomes.
Design, Setting, and Participants The ESCAPE trial was an unblinded, multicenter, randomized clinical superiority trial involving 30 Dutch hospitals participating in the Dutch Pancreatitis Study Group. From April 2011 until September 2016, a total of 88 patients with chronic pancreatitis, a dilated main pancreatic duct, and who only recently started using prescribed opioids for severe pain (strong opioids for ≤2 months or weak opioids for ≤6 months) were included. The 18-month follow-up period ended in March 2018.
Interventions There were 44 patients randomized to the early surgery group who underwent pancreatic drainage surgery within 6 weeks after randomization and 44 patients randomized to the endoscopy-first approach group who underwent medical treatment, endoscopy including lithotripsy if needed, and surgery if needed.
Main Outcomes and Measures The primary outcome was pain, measured on the Izbicki pain score and integrated over 18 months (range, 0-100 [increasing score indicates more pain severity]). Secondary outcomes were pain relief at the end of follow-up; number of interventions, complications, hospital admissions; pancreatic function; quality of life (measured on the 36-Item Short Form Health Survey [SF-36]); and mortality.
Results Among 88 patients who were randomized (mean age, 52 years; 21 (24%) women), 85 (97%) completed the trial. During 18 months of follow-up, patients in the early surgery group had a lower Izbicki pain score than patients in the group randomized to receive the endoscopy-first approach group (37 vs 49; between-group difference, −12 points [95% CI, −22 to −2]; P = .02). Complete or partial pain relief at end of follow-up was achieved in 23 of 40 patients (58%) in the early surgery vs 16 of 41 (39%)in the endoscopy-first approach group (P = .10). The total number of interventions was lower in the early surgery group (median, 1 vs 3; P < .001). Treatment complications (27% vs 25%), mortality (0% vs 0%), hospital admissions, pancreatic function, and quality of life were not significantly different between early surgery and the endoscopy-first approach.
Conclusions and Relevance Among patients with chronic pancreatitis, early surgery compared with an endoscopy-first approach resulted in lower pain scores when integrated over 18 months. However, further research is needed to assess persistence of differences over time and to replicate the study findings.
DOI: 10.1001/jama.2019.20967
Source: https://jamanetwork.com/journals/jama/article-abstract/2759004