NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE

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1 NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE INTERVENTIONAL PROCEDURES PROGRAMME Endoscopic transluminal drainage of pancreatic pseudocyst and pancreatic necrosectomy Removing dead tissue from the pancreas using an endoscope through the mouth. The pancreas produces juices that help to digest food. However, these digestive juices can attack the pancreas itself, for example if the tube that normally takes the juices to the gut becomes blocked. This can cause swelling of the pancreas and severe pain in the abdomen (acute pancreatitis). A serious complication of acute pancreatitis is pancreatic necrosis, which typically requires removal of the dead tissue, either by needle or open surgery. This procedure (transluminal endoscopic pancreatic necrosectomy) is an alternative treatment option. A thin telescope (called an endoscope) is inserted through the mouth. Special instruments are then passed through the stomach wall in order to wash out and remove the dead tissue. Introduction The National Institute for Health and Clinical Excellence (NICE) has prepared this overview to help members of the Interventional Procedures Advisory Committee (IPAC) make recommendations about the safety and efficacy of an interventional procedure. It is based on a rapid review of the medical literature and specialist opinion. It should not be regarded as a definitive assessment of the procedure. Date prepared This overview was prepared in March Procedure name Endoscopic transluminal drainage of pancreatic pseudocyst and pancreatic necrosectomy Specialty societies British Society for Gastroenterology necrosectomy Page 1 of 19

2 Association of Upper Gastrointestinal Surgeons Description Indications and current treatment Pancreatic necrosis (also called necrotising pancreatitis) is a serious complication of acute pancreatitis that can occur in some patients. It can occur with or without the formation of a pseudocyst and is associated with significant morbidity and high mortality. Patients typically require prolonged hospitalisation and intensive care management. Current treatment options for pancreatic necrosis include conventional open or laparoscopic necrosectomy and supportive management. What the procedure involves Using upper gastrointestinal endoscopy and endosonographic guidance under conscious sedation, and with CO 2 insufflation to aid visualisation, the retroperitoneal space is accessed via a diathermy puncture of the posterior gastric or duodenal wall. Balloon dilatation of the luminal puncture may be performed to enable endoscopic instrumentation and irrigation of the retroperitoneal space. Any retroperitoneal fluid collection is drained and any dead tissue removed. One or more stents or irrigation catheters (such as used in those used in endoscopic retrograde cholangio-pancreatography) may be left in situ to facilitate further drainage from the retroperitoneal space into the stomach. Repeated sessions may be needed, a few days apart. The technique aims to remove necrotic material without the need and morbidity associated with open surgical necrosectomy. Literature review Rapid review of literature The medical literature was searched to identify studies and reviews relevant to endoscopic transluminal drainage of pancreatic pseudocyst and pancreatic necrosectomy. Searches were conducted of the following databases, covering the period from their commencement to 9 th March 2011: MEDLINE, PREMEDLINE, EMBASE, Cochrane Library and other databases. Trial registries and the Internet were also searched. No language restriction was applied to the searches (see appendix C for details of search strategy). Relevant published studies identified during consultation or resolution that are published after this date may also be considered for inclusion. necrosectomy Page 2 of 19

3 The following selection criteria (table 1) were applied to the abstracts identified by the literature search. Where selection criteria could not be determined from the abstracts the full paper was retrieved. Table 1 Inclusion criteria for identification of relevant studies Characteristic Criteria Publication type Clinical studies were included. Emphasis was placed on identifying good quality studies. Abstracts were excluded where no clinical outcomes were reported, or where the paper was a review, editorial, or a laboratory or animal study. Conference abstracts were also excluded because of the difficulty of appraising study methodology, unless they reported specific adverse events that were not available in the published literature. Patient Patients with pseudocyst and / or pancreatic necrosis Intervention/test Endoscopic transluminal drainage of pancreatic pseudocyst and pancreatic necrosectomy Outcome Articles were retrieved if the abstract contained information relevant to the safety and / or efficacy. Language Non-English-language articles were excluded unless they were thought to add substantively to the English-language evidence base. List of studies included in the overview This overview is based on 286 patients from 2 non-randomised controlled trials 1,2 and 3 case series 3,4,5. Other studies that were considered to be relevant to the procedure but were not included in the main extraction table (table 2) have been listed in appendix A. necrosectomy Page 3 of 19

4 Table 2 Summary of key efficacy and safety findings on endoscopic transluminal drainage of pancreatic pseudocyst and pancreatic necrosectomy Abbreviations used: CT, computed tomography; ICU, intensive care unit; MRI, magnetic resonance imaging Study population: Patients with symptomatic pancreatic pseudocysts. Age: 51 years; Sex: not reported n = 83 (45 endoscopic transluminal, 16 laparoscopic, 22 open) Patient selection criteria: CT, MRI or ultrasound confirmed pancreatic pseudocyst. Technique: Endoscopy under procedural sedation, with a transmural approach with puncture through the posterior gastric wall. Guidewire insertion, balloon dilatation and stenting with double pigtail catheters. Vs laparoscopic approach, vs open surgery. Follow-up: 10 months (mean) Conflict of interest/source of funding: Not reported IP 913 Study details Key efficacy findings Key safety findings Comments Melman L (2009) 1 Non-randomised controlled study USA Number of patients analysed: n = 83 (45 endoscopic transluminal, 16 laparoscopic, 22 open) Complications Complications within 30 days of index procedure Endoscopic Laparoscopic Open Follow-up issues: Retrospective analysis Recruitment period: 1999 to 2007 Clinical success Urgent 6.7% (3/45) 0% 0% Study design issues: Primary success (symptom or cyst resolution after the surgical index intervention) rate intervention Endoscopic Laparoscopic Open p= 33.5% 87.5% 81.2% <0.01 (absolute numbers not reported, p value across all groups) 64.4% of all patients initially undergoing endoscopic drainage were managed successfully without open, laparoscopic, or percutaneous drainage (i.e. repeat endoscpic intervention was required) Overall success (symptom or cyst resolution at final follow up after any additional intervention) rate Endoscopic Laparoscopic Open p= 84.6% 93.8% 90.0% Not significant (absolute numbers not reported, p value across all groups) Operative characteristics Group mean and range (days) Endoscopic Laparoscopic Open Length of stay 3.9 (0 to 25) 6.9 (3 to 23) 10.8 (4 to 82) (measurement of significance not reported) Gastric perforation 4.4% (2/45) 0% 0% Bleeding 2.2% (1/45) 12.5% (2/16) 0% Haematemesis 2.2% (1/45) 0% 0% Multiple organ failure Wound infection Incisional hernia 0% 0% 4.5% (1/22) 0% 0% 4.5% (1/22) 0% 0% 9.1% (2/22) p value not significant for difference between groups for any complication All endoscopic procedures undertaken by 3 endoscopists. Patient selection for each treatment option is not described. Study population issues: No statistically significant difference between groups at baseline for age, gender, body mass index, aetiology of pancreatitis, or size of pseudocysts. Other issues: Inconsistency between the text and table for primary and secondary success outcomes. Those from the table are extracted here. necrosectomy Page 4 of 19

5 Abbreviations used: CT, computed tomography; ICU, intensive care unit; MRI, magnetic resonance imaging Study details Key efficacy findings Key safety findings Comments Gardener T (2009) 2 Number of patients analysed: n = 45 (25 direct Complications Follow-up issues: Non-randomised controlled study endoscopic transluminal, 20 standard drainage alone) Outcome Endoscopic Standard necrosectomy drainage USA Recruitment period: 2007 Study population: Patients with necrotising acute pancreatitis. Age: 62 years; Sex: 62 % male n = 45 (25 direct endoscopic transluminal necrosectomy, 20 standard drainage alone) Patient selection criteria: Patients with pancreatic fluid collections that had not resolved on observational treatment. No previous operative or endoscopic treatment. Patients with only air or fluid collections were not included. Technique: Endoscopy under conscious sedation; posterior gastric or duodenal wall punctured and tract enlarged with balloon; fluid contents aspirated and necrotic tissue removed. Vs standard drainage with stents and tubes. Repeat session every 3 to 7 days. Follow-up: 14 months (mean) Conflict of interest/source of funding: None Clinical success Group mean scores or % Outcome Endoscopic Standard p= necrosectomy drainage Successful 88% 45% resolution* Months to cavity resolution Recurrent 8% 40% collection Recurrent pancreatitis 0% 5% (absolute numbers not reported) * 90% resolution of cavity without further percutaneous or surgical intervention. Operative characteristics Group mean scores ± standard deviation Outcome Endoscopic Standard p= necrosectomy drainage Length of stay after initial drainage 15.4 ± ± Bleeding 32% (3 patients required haemoclips) 20% (p = 0.50; absolute numbers not reported) There was no requirement for repeat (postprocedural) endoscopy for bleeding in either group, and there were no luminal perforations. Retrospective study Study design issues: No multidisciplinary review process for patients so selection for endoscopic management was at the discretion of the endoscopic clinicians and those referring patients. Four experienced clinicians undertook all direct endoscopies. Imaging studies assessed blinded to treatment allocation. Study population issues: The length of time between onset of pancreatitis and referral for treatment varied from patient to patient. There were no statistically significant differences between the groups at baseline in demographic and most clinical characteristics. Patients in the direct endoscopic necrosectomy group were more likely to have gas component within the cavity (p = 0.034), and have disconnected parenchyma (p = 0.045). Other issues: None necrosectomy Page 5 of 19

6 Abbreviations used: CT, computed tomography; ICU, intensive care unit; MRI, magnetic resonance imaging Study details Key efficacy findings Key safety findings Comments Seifert H (2009) 3 Number of patients analysed: n = 93 Complications Follow-up issues: Case series Germany Recruitment period: 1999 to 2005 Short-term success (to 30-day follow-up) Short-term clinical success, defined as symptom-free and Outcome Bleeding (1 patient died, 2 required surgery) Rate 14.0% (13/93) Retrospective study. Study design issues: Six participating centres Study population: Patients with no further intervention required up to 30 days postprocedure, was achieved in 80.6% (75/93) of patients. abdominal cavity (1 patient between baseline and follow Perforation of necrosis in 5.4% (5/93) No comparison made (peri)pancreatic necrosis. Mean cavity size 11.4 cm, mean duration Mortality was 7.5% (7/93), and 11.8% (11/93) of patients died, 2 required surgery up for quality of life outcomes. since onset 41 days. Age: 57 years; required surgery. Fistula 2.2% (2/93) Sex: 68% male. n = 93 Patient selection criteria: Patients with infected necrosis, constant or intermittent fever, laboratory tests indicating fever or refractive to conservative management. Patients with significant amounts of solid necroses were included. Patients with collections which were mainly fluid, patients who had abscess with little necrotic material, and patients with necrosis extending into the lower abdomen / pelvis were excluded. Technique: Initial transgastric or transduodenal access with endoscopic or endosonograpic guidance to insert 2 stents (and irrigation catheter where necessary). Second session with balloon dilatation to allow gastroscope insertion, forceful irrigation, and endoscopic removal of debris with snares / forceps. Repeat sessions every 1 to 4 days. Follow-up: 43 months (mean) Conflict of interest/source of funding: None 51.6 % (48/93) of patients demonstrated radiological success (no residual necrosis or cyst on discharge). Long-term success (mean follow-up 43 months) Long-term clinical success was achieved in 67.7% (63/93) of all patients. One patient died in late follow-up relating to pancreatitis, and 11.8% (11/93) had recurrence. Quality of life Of the 68 patients with short-term clinical success who were still alive at 50-month follow-up, 47.1% (32/68) were still working, 45.6% (31/68) had retired, and 7.3% (5/68) had retired due to disease. Difficulty carrying heavy loads 27.9% (19/68) Difficulty walking round the block 10.3% (7/68) Difficulty leaving the house 7.3% (5/68) Difficulty with basic activities 8.8% (6/68) Changed diet 61.8% (42/68) Lost weight 13.2% (9/68) Fever or chills 5.9% (4/68) Jaundice 2.9% (2/68) Bloated sensation 25.0% (17/68) Mean patient self-assessment score (0 to 10 scale, lower scores better) Physical condition 2.47 points, quality of life 2.35 points Air embolism (1 patient died, 1 cerebral infarction) Complications in other organs requiring surgery 2.2% (2/93) 2.2% (2/93) Inclusion criteria might not have been uniform across all participating centres. Study population issues: Patients selected for endoscopic or US guidance initial placement of stents and irrigation catheter based on endoscopic aspect. Some patients had significant comorbidity that might have influenced quality of life outcomes. Possible case selection bias with severely ill patients treated surgically. However, a few early cases were severely ill patients in whom surgery was not deemed possible due to poor health status. Other issues: Endoscopic retrograde cholangio-pancreatography was performed in 63 patients before or during treatment sessions. 45 patients also received ductal endotherapy (sphincterotomy and / or stenting). necrosectomy Page 6 of 19

7 Abbreviations used: CT, computed tomography; ICU, intensive care unit; MRI, magnetic resonance imaging Study details Key efficacy findings Key safety findings Comments Beckingham I J (1999) 4 Number of patients analysed: n = 27 Complications Follow-up issues: Outcome Rate Case series Clinical success Bleeding (requiring surgery in % (4/34) patient) South Africa Recruitment period: Not reported (2 year duration) Study population: Patients with pancreatic pseudo cysts. Age: 38 years; Sex: 79% male. Mean diameter 8cm. n = 34 Patient selection criteria: Not reported Technique: Conscious sedation, endoscopy with side viewing endoscope, needle knife used to create hole in the duodenal / gastric wall. Incision enlarged with a sphinctertome for drainage. Pigtail stent insertion in 7 patients. Repeat sessions in 5 patients. Follow-up: 46 months (nedian) Conflict of interest/source of funding: not reported Initial success (not otherwise defined) was achieved in 70.6% (24/34) of patients. There was technical failure in 29.4% (10/34) of patients with inability to penetrate the pseudocyst wall. Recurrence of pseudocyst was reported in 8.8% (3/34)of patients (at 2, 12, and 18 months respectively), resulting in a long-term success rate of 61.8% (21/34). Perforation (treated with antibiotics) 2.9% (1/34) Retrospective study. 2 patients died due to unrelated causes, and 5 were lost to follow up. Study design issues: Not clear whether denominator for efficacy outcomes include those in whom the endoscopic procedure was not technically possible. Outcomes also reported separately for gastric or duodenal access. Patient selection criteria not reported. Study population issues: Few clinical characteristics of patients are reported. Other issues: None necrosectomy Page 7 of 19

8 Abbreviations used: CT, computed tomography; ICU, intensive care unit; MRI, magnetic resonance imaging Study details Key efficacy findings Key safety findings Comments Papachristou G I (2007) 5 Number of patients analysed: n = 53 Complications Follow-up issues: Outcome Rate Prospective follow-up. Case series Procedure success Any complication 20.7% (11/53) Three patients died during USA 81.1% (43/53) of patients had successful drainage / Bleeding (repeat endoscopy 17.0% (9/53) follow-up, unrelated to the Recruitment period: 1998 to 2006 debridement (defined as complete or almost complete in 2 patients, ICU and procedure. resolution of the collection and resolution of clinical transfusion in 2 patients) Study design issues: symptoms). Gallbladder puncture 1.9% (1/53) Considerable variation in Study population: Patients with Complete resolution of walled-off pancreatic necrosis in 23 (requiring bile duct stenting) technique used between symptomatic (n = 27) or infected (n patients and marked improvement in 20. = 26) walled off pancreatic Hypotension / loss of access 1.9% (1/53) patients. necrosis. Age: 61 years; Sex: 53% 39.6% (21/53) of patients required concurrent to collection male. percutaneous drainage. Stent migration 3.8% (2/53) n = 53 Patient selection criteria: Patients otherwise candidates for open necrosectomy with CT or MRI imaging confirmation of pancreatic necrosis. Technique: Conscious sedation. Endoscopy with side-viewing duodenoscope. Transmural puncture of the posterior gastric wall or the medial duodenal wall at site of compression. Puncture tract dilation by balloon. One (25%) or two (75%) pigtail stents inserted and nasobiliary tube positioned. Aggressive irrigation and debridement / resection. Median of 3 endoscopic sessions. 22.6% (12/53) of patients required open intervention at a median of 47 days follow-up. Size of pancreatic necrosis was an independent predictor of requirement for open surgery on multivariate analysis (p = 0.01). Operative characteristics The irrigation catheter was removed after a median of 31 days follow-up. Median length of stay in hospital was 31 days (range 0 to 90). Four clinicians undertook the endoscopic procedures (previousexperience not reported). Study population issues: A significant proportion of patients had comorbidities such as diabetes mellitus (27%), coronary artery disease (21%), cancer (13%), immunosuppression (11%), and chronic obstructive pulmonary disease (11%). Other issues: Endoscopic drainage of other pancreatic collections were also undertaken at the same centre. Follow-up: 6 months (mean) Conflict of interest/source of funding: Not reported necrosectomy Page 8 of 19

9 Efficacy Resolution of cysts or necrosis Procedural success and short-term efficacy A non-randomised controlled study of 45 patients reported that significantly more patients had successful resolution (90% resolution of the cavity, not otherwise defined, without further surgical or percutaneous intervention) following direct endoscopic transluminal necrosectomy than following standard drainage alone at 4-month follow-up (88% vs 45%, p = 0.003) (absolute figures not reported) 2. A case series of 93 patients reported that short-term (up to 30 days) clinical success (symptom-free with no further intervention) was achieved in 81% (75/93) of patients 3.Longer-term efficacy In the non-randomised controlled study of 45 patients, significantly fewer patients in the endoscopic group than in the standard drainage group had recurrent collections identified on computed tomography imaging at follow-up of more than 6 months (8% vs 40%, p = 0.014) (absolute figures not reported) 2. In the case series of 93 patients treated by the endoscopic procedure reported that long-term clinical success (mean follow-up 43 months) was achieved in 68% (63/93) of patients 3. A case series of 53 patients reported that successful drainage (defined as complete or almost complete resolution of collection and no clinical symptoms) was achieved in 81% (43/53) of patients at 6-month follow-up 5. However, 40% (21/53) of patients had concurrent percutaneous drainage at the time of the index procedure. In a non-randomised study of 83 patients comparing endoscopic transluminal vs. laparoscopic vs. open surgical drainage (45, 16, 22 patients in each group respectively), 64.4% (29/45) of all patients treated by endoscopic transluminal drainage were managed successfully without the need for subsequent laparoscopic or open drainage 1. Functional outcome The series of 93 patients reported that, of the 68 patients with short-term clinical success who were still alive at 50-month follow-up, 28% (19/68) had difficultly carrying heavy loads; 10% (7/68) had difficulty walking around the block; 7% (5/68) had difficultly leaving the house; and 9% (6/68) had difficulty with basic activities at 43-month follow-up 3. Five patients (7%) had retired from work due to the disease. necrosectomy Page 9 of 19

10 Safety Bleeding The non-randomised controlled study of 45 patients reported no significant difference in the occurrence of bleeding between patients in the endoscopic group and those treated by standard drainage alone (32% vs 20%, p = 0.50) (absolute figures and length of follow-up not reported) 2. In the two case series (146 patients), bleeding occurred in 22 (15%). In the series of 93 patients, 1 patient died as a consequence of bleeding and 2 required surgery 3. In the series of 53 patients, 2 required repeat endoscopy and 2 required intensive care and blood transfusion 5. Air embolism The series of 93 patients reported air embolism in 2% (2/93) of patients (1 patient died and 1 had a non-fatal cerebral infarction) 3. Perforation of necrotic abdominal cavity The series of 93 patients reported perforation of necrosis in the abdominal cavity in 2% (2/93) of patients (1 patient died and 2 required surgery) 3. Fistula The series of 93 patients reported fistula (not otherwise described) in 2% (2/93) of patients 3. Gallbladder puncture The series of 53 patients reported that gallbladder puncture requiring bile duct stenting occurred in 1 patient (clinical sequelae not reported) 5. Validity and generalisability of the studies Lack of clarity in procedure descriptions regarding endoscopic technique employed. Inconsistency between studies with regard to definition of successful procedure. Few long-term outcomes are reported. necrosectomy Page 10 of 19

11 Existing assessments of this procedure There were no published assessments from other organisations identified at the time of the literature search. Related NICE guidance Below is a list of NICE guidance related to this procedure. Appendix B gives details of the recommendations made in each piece of guidance listed. Interventional procedures Percutaneous endoscopic retroperitoneal necrosectomy. NICE interventional procedures guidance 384 (2011). Specialist Advisers opinions Specialist advice was sought from consultants who have been nominated or ratified by their Specialist Society or Royal College. The advice received is their individual opinion and does not represent the view of the society. Mr A Makin (British Society of Gastroenterology), Mr M Wilkinson (British Society of Gastroenterology) The one Specialist Advisor who commented categorised this procedure as novel and of uncertain safety and efficacy. The main comparator to this procedure would be percutaneous drainage for pseudocysts, or open / laparoscopic surgical intervention for necrosectomy. The key efficacy outcomes for this procedure are resolution of pain / inflammation, reduction of cyst size, length of stay, number of procedures required, and recurrence rate Adverse events known from experience or reports include bleeding, perforation, leak of cyst contents, technical failure, and misidentification of organ to be drained. Additional theoretical adverse events may include Infection, and death It may sometimes merely delay, rather than obviate the need for, surgery The hospital requires an integrated hepatobiliary team, with endoscopist, radiologist and surgeon necrosectomy Page 11 of 19

12 The procedure requires training in endoscopic ultrasound and therapeutic endoscopy to enable completion of procedure and ability to deal with immediate complications. The impact on the NHS is likely to be minor, and if found to be safe and efficacious is likely to be offered at fewer than ten specialist centres. Patient Commentators opinions NICE s Patient and Public Involvement Programme was unable to gather patient commentary for this procedure. Issues for consideration by IPAC The degree of active debridement of necrotic tissue varied within and between studies. Many but not all patients had infected pancreatic necrosis. necrosectomy Page 12 of 19

13 References 1 Melman L, Azar R, Beddow K et al. (2009) Primary and overall success rates for clinical outcomes after laparoscopic, endoscopic, and open pancreatic cystgastrostomy for pancreatic pseudocysts. Surgical Endoscopy and Other Interventional Techniques 23: Gardner TB, Chahal P, Papachristou GI et al. (2009) A comparison of direct endoscopic necrosectomy with transmural endoscopic drainage for the treatment of walled-off pancreatic necrosis. Gastrointestinal Endoscopy 69: Seifert H, Biermer M, Schmitt W et al. (2009) Transluminal endoscopic necrosectomy after acute pancreatitis: A multicentre study with long-term follow-up (the GEPARD Study). Gut 58: Beckingham IJ, Krige JEJ, Bornman PC et al. (1999) Long term outcome of endoscopic drainage of pancreatic pseudocysts. American Journal of Gastroenterology 94: Papachristou GI, Takahashi N, Chahal P et al. (2007) Peroral endoscopic drainage/debridement of walled-off pancreatic necrosis. Annals of Surgery 245: necrosectomy Page 13 of 19

14 Appendix A: Additional papers on endoscopic transluminal drainage of pancreatic pseudocyst and pancreatic necrosectomy The following table outlines the studies that are considered potentially relevant to the overview but were not included in the main data extraction table (table 2). It is by no means an exhaustive list of potentially relevant studies. necrosectomy Page 14 of 19

15 Article Number of patients/followup Direction of conclusions Reasons for noninclusion in table 2 Baron, T. H., Thaggard, W. G., Morgan, D. E et al (1996) Endoscopic therapy for organized pancreatic necrosis. Gastroenterology 111 (3) n = 11 FU = 4 to 18 months Endoscopic therapy may be a viable management option for a subset of patients who remain symptomatic after an episode of acute pancreatic necrosis after the necrosis has become organized and partially liquefied Larger studies included in table 2 Donnelly, P. K., Lavelle, J., and Carr- Locke, D. (1990) Massive haemorrhage following endoscopic transgastric drainage of pancreatic pseudocyst. British Journal of Surgery 77 (7) n = 1 FU = 3 months Report of a case of endoscopic drainage of a pseudocyst which resulted in immediate massive life threatening haemorrhage Larger studies included in table 2 No additional safety outcomes not reported elsewhere in the literature Escourrou, J., Shehab, H., Buscail, L. et al (2008) Peroral transgastric/transduodenal necrosectomy: success in the treatment of infected pancreatic necrosis. Annals of Surgery 248 (6) n = 13 FU = 20 months This technique is highly effective and safe in the treatment of infected organized pancreatic necrosis. Results are achievable and sustainable with a limited number of sessions Larger studies included in table 2 Grewal, H. P., London, N. J. M., Carr- Locke, D., et al (1990) Endoscopic drainage of a recurrent pancreatic pseudocyst. Postgraduate Medical Journal 66 (782) n = 1 FU = 6 months Endoscopic cystogastrostomy is a relatively new technique which is illustrated by the following case report, the first in the UK literature Larger studies included in table 2 Pallapothu, R., Earle, D. B., Desilets, D. J et al (2011) NOTES stapled cystgastrostomy: a novel approach for surgical management of pancreatic pseudocysts. Surgical Endoscopy 25 (3) n = 6 FU = 3 months NOTEScystgastrostomy is comparable to previously described surgical approaches, yet is as minimally invasive as endoscopic drainage procedures previously described for management of pseudocysts. It is less invasive than laparoscopic or open cystgastrostomy, yet provides definitive treatment Larger studies included in table 2 De Palma, G. D., Galloro, G., Puzziello, A et al (2002) Endoscopic drainage of pancreatic pseudocysts: A long-term follow-up study of 49 patients. n = 49 FU = 26 months Endoscopic drainage provides a successful and safe minimally invasive approach to pancreatic pseudocyst management Larger studies included in table 2 Hepato-Gastroenterology 49 (46) Sharma, S. S., Bhargawa, N., and Govil, A. (2002) Endoscopic management of n = 38 Endoscopic management of pancreatic pseudocyst is quite an effective and safe mode of Larger studies included in table 2 necrosectomy Page 15 of 19

16 pancreatic pseudocyst: A long-term follow-up. Endoscopy 34 (3) FU = 44 months treatment in experienced hands. ERCP before the procedure is only required when the cyst does not bulge into gut lumen, for a decision about the feasibility of transpancreatic drainage Endoscopic treatment of OPN is preferable if cooperation with surgeons and radiologists is accessible. It should be stressed that the risk of complications related to this method of management does not endanger patient's life Smoczynski, M., Rompa, G., Marek, I. et al (2008) Complications of endoscopic therapy of pancreatic organized necrosis. Gastroenterologia Polska 15 (1) n = 46 FU = not reported Larger studies included in table 2 No additional safety outcomes not reported elsewhere in the literature necrosectomy Page 16 of 19

17 Appendix B: Related NICE guidance for endoscopic transluminal drainage of pancreatic pseudocyst and / or pancreatic necrosis Guidance Interventional procedures Recommendations Percutaneous retroperitoneal endoscopic necrosectomy. NICE interventional procedures guidance 384 (2011) 1.1 Current evidence on the safety and efficacy of percutaneous retroperitoneal endoscopic necrosectomy is adequate to support the use of this procedure provided that normal arrangements are in place for clinical governance, consent and audit. 1.2 The procedure should only be carried out by a team experienced in the management of complex pancreatic disease. necrosectomy Page 17 of 19

18 Appendix C: Literature search for endoscopic transluminal drainage of pancreatic pseudocyst and / or pancreatic necrosis Database Date searched Version/files Cochrane Database of 09/03/2011 Issue 2 of 12, Feb 2011 Systematic Reviews CDSR (Cochrane Library) Database of Abstracts of 09/03/2011 N/A Reviews of Effects DARE (CRD website) HTA database (CRD website) 09/03/2011 N/A Cochrane Central Database of 09/03/2011 Issue 2 of 12, Feb 2011 Controlled Trials CENTRAL (Cochrane Library) MEDLINE (Ovid) 08/03/ to February week MEDLINE In-Process (Ovid) 08/03/ March 2011 EMBASE (Ovid) 08/03/2011 EMBASE 1980 to 2011 Week 09 CINAHL (NLH Search 09/03/ Present 2.0/EBSCOhost) BLIC (Dialog DataStar) 10/03/ The following search strategy was used to identify papers in MEDLINE. A similar strategy was used to identify papers in other databases. 1 exp Pancreatic Cyst/ 2 (pancreat* adj3 (cyst* or pseudocyst* or necros*)).tw. 3 Pancreatitis, Acute Necrotizing/ 4 (Pancreatit* adj3 Acute Necrot*).tw. 5 (pancreat* adj3 abscess*).tw. 6 or/1-5 7 Necrosis/ 8 Pancreatitis/ 9 7 and or 9 11 Pancreatitis/ or 11 ((endoscop* or translum* or transgast*) adj3 (drain* or 13 necrosect* or debridement or surg*)).tw. 14 Natural Orifice Endoscopic Surgery/ necrosectomy Page 18 of 19

19 15 NOTES.tw. 16 (minimal access adj3 necrosect*).tw. 17 or/ and limit 11 to yr=" " or and Animals/ not Humans/ not 22 necrosectomy Page 19 of 19