Objective: To investigate the diagnosis and treatment for enterocutaneous fistula (ECF) in China, and to explore the prognostic factors of ECF. Methods: A multi-center cross-sectional study was conducted based on the Registration System of Chinese Gastrointestinal Fistula and Intra-Abdominal Infections to collect the clinical data of ECF patients from 54 medical centers in 22 provinces/municipalities from January 1, 2018 to December 31, 2018. The clinical data included patient gender, age, length of hospital stay, intensive care unit (ICU) admission, underlying diseases, primary diseases, direct causes of ECF, location and type of ECF, complications, treatment and outcomes. All medical records were carefully filled in by the attending physicians, and then re-examined by more than two specialists. The diagnosis of ECF was based on the clinical manifestations, laboratory/imaging findings and intraoperative exploration. Results: A total of 1521 patients with ECF were enrolled, including 1099 males and 422 females, with a median age of 55 years. The top three primary diseases of ECF were malignant tumors in 626 cases (41.2%, including 540 gastrointestinal tumors, accounting for 86.3% of malignant tumors), gastrointestinal ulcers and perforations in 202 cases (13.3%), and trauma in 157 cases (10.3%). The direct causes of ECF were mainly surgical operation in 1194 cases (78.5%), followed by trauma in 156 (10.3%), spontaneous fistula due to Crohn's disease in 92 (6.0%), radiation intestinal injury in 41 (2.7%), severe pancreatitis in 20 (1.3%), endoscopic treatment in 13 (0.9%) and 5 cases (0.3%) of unknown reasons. All the patients were divided into three groups: 1350 cases (88.7%) with simple ECF, 150 (9.9%) with multiple ECF, and 21 (1.4%) with combined internal fistula. Among the patients with simple ECF, 438 cases (28.8%) were jejuno-ileal fistula, 313 (20.6%) colon fistula, 170 (11.2%) rectal fistula, 111 (7.3%) duodenal fistula, 76 (5.0%) ileocecal fistula, 65 (4.3%) ileocolic anastomotic fistula, 55 (3.6%) duodenal stump fistula, 36 (2.4%) gastrointestinal anastomotic fistula, 36 (2.4%) esophagogastric/esophagojejunal anastomotic fistula, 29 (1.9%) gastric fistula and 21 (1.4%) cholangiopancreatiointestinal. Among all the simple ECF patients, 991 were tubular fistula and 359 were labial fistula. A total of 1146 patients finished the treatment, of whom 1061 (92.6%) were healed (586 by surgery and 475 self-healing) and 85 (7.4%) died. A total of 1043 patients (91.0%) received nutritional support therapy, and 77 (6.7%) received fistuloclysis. Infectious source control procedures were applied to 1042 patients, including 711 (62.0%) with active lavage and drainage and 331 (28.9%) with passive drainage. Among them, 841 patients (73.4%) underwent minimally invasive procedures of infectious source control (replacement of drainage tube through sinus tract, puncture drainage, etc.), 201 (17.5%) underwent laparotomy drainage, while 104 (9.1%) did not undergo any drainage measures. A total of 610 patients (53.2%) received definitive operation, 24 patients died within postoperative 30-day with mortality of 3.9% (24/610), 69 (11.3%) developed surgical site infection (SSI), and 24 (3.9%) had a relapse of fistula. The highest cure rate was achieved in ileocecal fistula (100%), followed by rectal fistula (96.2%, 128/133) and duodenal stump fistula (95.7%,44/46). The highest mortality was found in combined internal fistula (3/12) and no death in ileocecal fistula. Univariate prognostic analysis showed that primary diseases as Crohn's disease (χ(2)=6.570, P=0.010) and appendicitis/appendiceal abscess (P=0.012), intestinal fistula combining with internal fistula (χ(2)=5.460, P=0.019), multiple ECF (χ(2)=7.135, P=0.008), esophagogastric / esophagojejunal anastomotic fistula (χ(2)=9.501, P=0.002), ECF at ileocecal junction (P=0.012), non-drainage/passive drainage before the diagnosis of intestinal fistula (χ(2)=9.688, P=0.008), non-drainage/passive drainage after the diagnosis of intestinal fistula (χ(2)=9.711, P=0.008), complicating with multiple organ dysfunction syndrome (MODS) (χ(2)=179.699, P<0.001), sepsis (χ(2)=211.851, P<0.001), hemorrhage (χ(2)=85.300, P<0.001), pulmonary infection (χ(2)=60.096, P<0.001), catheter-associated infection (χ(2)=10.617, P=0.001) and malnutrition (χ(2)=21.199, P<0.001) were associated with mortality. Multivariate prognostic analysis cofirmed that sepsis (OR=7.103, 95%CI:3.694-13.657, P<0.001), complicating with MODS (OR=5.018, 95%CI:2.170-11.604, P<0.001), and hemorrhage (OR=4.703, 95%CI: 2.300-9.618, P<0.001) were independent risk factors of the death for ECF patients. Meanwhile, active lavage and drainage after the definite ECF diagnosis was the protective factor (OR=0.223, 95%CI: 0.067-0.745, P=0.015). Conclusions: The overall mortality of ECF is still high. Surgical operation is the most common cause of ECF. Complications e.g. sepsis, MODS, hemorrhage, and catheter-associated infection, are the main causes of death. Active lavage and drainage is important to improve the prognosis of ECF.
目的： 了解当前全国范围内肠外瘘的诊治情况，探讨影响肠外瘘预后的影响因素。 方法： 采用多中心横断面研究方法。依托中国肠瘘与腹腔感染注册系统，收集2018年1月1日至12月31日期间，我国22个省市、直辖市共54家医疗中心收治住院的肠外瘘病例临床资料，包括患者性别、年龄、住院时间、重症监护室（ICU）入住情况、基础疾病、原发疾病、直接导致肠外瘘的原因、肠外瘘部位和类型、并发症、治疗措施与疾病转归情况。所有病例资料由主治医师认真填写，再由两名以上专科医师重新审定登记病例信息，依据患者临床表现、实验室/影像学检查结果以及术中探查情况明确肠外瘘诊断，确定是否可纳入研究。 结果： 共纳入1 521例肠外瘘患者，其中男性1 099例，女性422例；中位年龄55岁。肠外瘘的原发疾病位列前三的分别是恶性肿瘤626例（41.2%，其中胃肠道肿瘤540例，占恶性肿瘤的86.3%）、消化道溃疡和穿孔202例（13.3%）以及创伤157例（10.3%）。有1 194例（78.5%）以外科手术为直接致瘘原因；其次为创伤156例（10.3%）、克罗恩病自发瘘92例（6.0%）、放射性肠损伤41例（2.7%）、重症胰腺炎20例（1.3%）及内镜手术13例（0.9%）；还有5例（0.3%）致瘘原因不明。单发肠外瘘1 350例（88.7%），多发肠外瘘150例（9.9%），合并肠内瘘者21例（1.4%）。单发肠外瘘中，空回肠瘘438例（28.8%）；随后依次为结肠瘘313例（20.6%）、直肠瘘170例（11.2%）、十二指肠瘘111例（7.3%）、回盲部瘘76例（5.0%）、回结肠吻合口瘘65例（4.3%）、十二指肠残端瘘55例（3.6%）、胃肠吻合口瘘36例（2.4%）、食管胃/肠吻合口瘘36例（2.4%）、胃瘘29例（1.9%）及胆胰肠吻合口瘘21例（1.4%）。所有单发肠外瘘患者中管状瘘患者991例，唇状瘘患者359例。共有1 146例患者完成治疗，总计治愈1 061例（92.6%），其中手术治愈586例，自愈475例；死亡85例（7.4%）。1 043例（91.0%）患者采取了营养支持治疗，77例（6.7%）进行了消化液的收集回输。确诊肠瘘后，感染源控制措施包括主动冲洗引流711例（62.0%）和被动引流331例（28.9%），其中841例（73.4%）在行感染源控制措施时采取微创形式（经原窦道更换引流管、穿刺引流等），而有201例（17.5%）进行了开腹手术引流，104例（9.1%）无引流措施。有610例（53.2%）采取了确定性手术治疗，术后30 d内死亡24例（3.9%），发生手术部位感染（SSI）69例（11.3%），术后再次发生肠瘘24例（3.9%）。全组治愈率最高的为回盲部瘘（100%），其次为直肠瘘（96.2%，128/133）和十二指肠残端瘘（95.7%，44/46）。病死率最高的为合并肠内瘘者（3/12），回盲部瘘患者无病死者。预后单因素分析结果显示，原发疾病为克罗恩病（χ(2)=6.570，P=0.010）和阑尾炎/阑尾脓肿（P=0.012）的患者、肠瘘类型为合并肠内瘘（χ(2)=5.460，P=0.019）、多发肠外瘘（χ(2)=7.135，P=0.008）、食管胃/肠吻合口瘘（χ(2)=9.501，P=0.002）和回盲部瘘（P=0.012）的患者、确诊肠瘘前无引流或被动引流者（χ(2)=9.688，P=0.008）、确诊肠瘘后无引流或被动引流者（χ(2)=9.711，P=0.008）、合并有多器官功能障碍综合征（χ(2)=179.699，P<0.001）、脓毒症（χ(2)=211.851，P<0.001）、出血（χ(2)=85.300，P<0.001）、肺部感染（χ(2)=60.096，P<0.001）、导管感染（χ(2)=10.617，P=0.001）和营养不良（χ(2)=21.199，P<0.001）与病死率有关。多因素分析提示，并发脓毒症（OR=7.103，95%CI：3.694~13.657，P<0.001）、多器官功能障碍综合征（OR=5.018，95%CI：2.170~11.604，P<0.001）和出血（OR=4.703，95%CI：2.300~9.618，P<0.001）是肠外瘘患者死亡的独立危险因素，确诊肠外瘘后行主动冲洗引流是患者死亡的保护因素（OR=0.223，95%CI：0.067~0.745，P=0.015）。 结论： 肠外瘘的总体死亡率仍较高，外科手术是导致肠外瘘发生的主要因素。脓毒症、多器官功能障碍综合征、出血、导管相关性感染是肠外瘘患者的主要死因。实施主动冲洗引流是改善肠外瘘患者预后的重要手段。.
Keywords: Enterocutaneous fistula; Multicenter study; Prognostic factors.