Fully Covered Self-Expanding Metal Stent for Perforations Related to Intra-procedural or Late Diagnosed Type II Endoscopic Retrograde Cholangiopancreatography | BMC Gastroenterology


According to the present study, patients with type II ERCP-induced perforation can mainly be treated non-surgically, and FCSEMS is an effective method to treat patients with type II ERCP-induced perforation. The results of this study showed that FCSEMS is not only effective in type II perforations detected during the procedure, but also in perforations detected later after the procedure, and that FCSEMS significantly reduces the length of stay at the hospital.

To our knowledge, this is the first study to compare late FCSEMS with concurrent FCSEMS and conventional follow-up, and it found that concurrent and late FCSEMS can provide effective results. Case reports and a series of four cases on the use of rescue FCSEMS have already been published [10, 11].

Recently, the treatment of perforations induced by ERCP has undergone significant changes. Treatment of ERCP-induced duodenal perforations is determined by the location and type of perforation as well as the patient’s clinical condition. The type of puncture wound is one of the most important considerations in treatment. Stafer et al. classified perforations into four types based on the mechanism of injury and the anatomical position of the perforation. Being the most common type of perforation, Type II perforations are periampullary perforations of the medial duodenal wall that are usually caused by a biliary or pancreatic sphincterotomy or a precut papillotomy. [12]. Unlike Type I perforations which primarily require surgical intervention, a non-surgical approach is feasible in most patients with Type II perforations [13]. Endoscopic treatment modalities have also been defined, in addition to non-operative follow-up. Nasobiliary drainage, often known as stenting, is a procedure to drain bile and pancreatic fluid to the duodenum [14]. FCSEMS can be used to cover the puncture line, preventing leakage while allowing biliary drainage. Similar to leaky esophagus and sleeve gastrectomy, the fully covered metal stent prevents leakage due to the radial force it applies to the leaky area, thereby limiting inflammation and peritonitis. Additionally, epithelialization through the stent can speed up the healing process. Therefore, we believe that the FCSEMS should be used both in cases where perforations are discovered during the procedure and in cases where perforations are discovered afterwards.

Odemis et al. compared 10 patients who received intra-procedural FCSEMS for type II perforations with another group of 10 patients who received nasobiliary drainage; they reported that patients who received FCSEMS required fewer pain medications, had lower white blood cell counts on the first day, and spent less time in the hospital [8]. Tringali et al. also reported successfully treating 16 patients by performing concurrent FCSEMS [15]. FCSEMS is useful for treating type II perforations, as observed in these two studies, which are similar to the results of the current study. With the exception of one patient, all FCSEMS procedures were performed concurrently in these studies. Only 10 (35.7%) of the 28 patients in our series were diagnosed during the procedure, and 9 of them simultaneously received FCSEMS. After the second ERCP, 10 patients underwent FCSEMS. In all patients who underwent FCSEMS, no surgery or percutaneous drainage was required. The duration of hospitalization of the group of patients undergoing FCSEMS was found to be significantly shorter than that of the group of patients undergoing conventional follow-up. These results indicate that FCSEMS can be performed safely in patients with type II ERCP-induced perforation and that FCSEMS is associated with shorter hospital stay.

The prognostic importance of early diagnosis of perforations has been demonstrated in previous studies [4, 16]. Type I Stapfer perforations are easier to recognize during or immediately after ERCP. However, Type II Stapfer perforations may be more difficult to diagnose during ERCP. Symptoms of these perforations are less distinct [17]. In the literature, there are a variety of series on the time it takes to diagnose ERCP-induced perforations. In the series where FCSEMS is applied simultaneously, it is found that the rate of perforations diagnosed during the procedure is quite high. [8, 15]. However, in many series in the literature, the concurrent diagnosis rate is not so high. Although Theopistos et al. were able to diagnose the perforations within the first 12 hours of their series of 24 cases of type II perforations only, concurrent diagnosis was made in only 3 (12.5%) patients [13]. Similarly, in a series of 61 cases by Kumbhari et al., researchers were able to make the diagnosis during the procedure in only 10% of cases and reported that the mean time to diagnosis was 23.6 ± 12.8 hours [4]. In our study, 35.7% of patients received concurrent diagnosis of their perforations (n: 10). Simultaneous FCSEMS were performed on nine of these patients. In one patient who developed a perforation during precut, simultaneous FCSEMS could not be performed because intraoperative cannulation was not feasible. A total of 10 patients underwent ERCP within 7–48 h and then salvage FCSEMS was performed. No surgery or percutaneous drainage was required in any of the patients undergoing early or late FCSEMS. There was no difference between the concurrent FCSEMS and late FCSEMS groups in length of hospitalization or other outcomes. According to these results, which demonstrate the safety of FCSEMS in the treatment of late-diagnosed perforations, patients with concurrently-diagnosed perforations and those with late-diagnosed perforations can benefit from effective endoscopic treatment methods. There is insufficient data in the literature on the timing of a second ERCP. In one of the larger series, Cochrane et al. placed FCSEMS in 23 patients with a 100% success rate for post-ERCP bleeding [18]. There must be a golden time for a second ERCP, as the perforation will gradually increase inflammation in the periampullary region. A second ERCP is defined as a safe procedure 2-4 days after failure of the first biliary cannulation [19, 20]. Since type 2 perforations already have a sphincterotomy, cannulation is not difficult in the very early period. In this study, all ERCP interventions were performed 7 to 48 h after the first procedure. It may be unsafe to perform the next ERCP after 48 h of the first ERCP due to severe inflammation.

In our series, which is based on a multidisciplinary review of patients with diagnosed perforations after the procedure, patients with more stable clinical findings were followed conventionally and those with more distinct findings in clinical assessment or examinations. FCSEMS rescue imaging-based were provided as a second intervention. However, none of these patients who underwent salvage FCSEMS required further intervention. In the conventional follow-up group, percutaneous drainage was required in one patient and surgical treatment in another patient. These data show that diversionary treatment with FCSEMS is useful in type II perforations. Similar to our series, in a 10-case series by Odemis et al., a 16-case series by Tringali et al., and a 15-case series by Trikudanatan et al., the success rates in FCSEMS of perforations were reported to be 100% in preventing mortality and the need for surgery [8, 15, 21]. In 17 of 18 patients with type II perforation, Bill et al. used endoscopic treatment with FCSEMS or plastic stents, and found that percutaneous drainage was needed in one patient who received a plastic stent, but no additional intervention was needed in any of the patients who received FCSEMS [22]. To prove that FCSEMS can reduce the need for surgery, further series with larger samples are needed.

An optimal time for FCSEMS extraction has not been clearly established. It has been stated to be a safe procedure to remove FCSEMS within 30 days [10]. In previous series where FCSEMS was applied for ERCP perforation, removal of FCSEMS was reported after a median of 10 and 43 days [8, 15]. In our series, the mean time to stent removal was 29.9 days and no complications related to this procedure were observed.

The most important limitations of the current study include its single center and retrospective nature as well as the small sample size it studies. In addition, the FCSEMS was performed on all patients with perforation detected during the procedure and only on those whose clinical or laboratory findings were more distinct in the other group of patients with perforation diagnosed late, resulting in a inhomogeneity between groups. However, due to ethical and clinical difficulties in conducting the study, creating a prospective, multicenter study on a topic like post-ERCP perforation is extremely difficult. Despite these limitations, the current study is one of the largest case series in the literature and the first to investigate late FCSEMS.


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