Distal Pancreatectomy A randomized controlled trial to compare two different surgical techniques DISPACT-TRIAL

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1 Trial Protocol SDGC 2004/01 Ethics committee (Heidelberg): 245/2006 Distal Pancreatectomy A randomized controlled trial to compare two different surgical techniques DISPACT-TRIAL ISRCTN Protocol written by: Dr. med. M.K. Diener Dr. med. C.M. Seiler Dr. med. H.P. Knaebel Dipl.-Inform. Med. Andreas Deckert Dr. sc. hum. S. Witte DISPACT TRIAL Amendment II 18. Januar 2007 page 1 of 62

2 TABLE OF CONTENTS 1 GENERAL INFORMATION TITLE OF THE TRIAL COORDINATING / PRINCIPLE INVESTIGATOR SCIENTIFIC DISCIPLINE AND FIELD OF WORK SCHEDULED DURATION STAFF AND INSTITUTION S CONTRIBUTION FUNDING REGISTRATION INVESTIGATORS, SPONSOR, BIOMETRICIAN AND MONITOR OVERVIEW TRIAL DESIGN AND IMPLEMENTATION FLOWCHART SUMMARY ABBREVIATIONS AND DEFINITIONS THE MEDICAL PROBLEM EVIDENCE THE NEED FOR A TRIAL AIM OF THE TRIAL TRIAL DESIGN TRIAL POPULATION PRIMARY OBJECTIVE SECONDARY OBJECTIVE HYPOTHESIS SELECTION AND WITHDRAWAL OF PATIENTS Inclusion/Exclusion criteria Subject withdrawal criteria CRITERIA FOR THE SELECTION OF TRIAL SITES PRIMARY AND SECONDARY ENDPOINTS METHODS AGAINST BIAS Randomization Stratification Blinding Confounding TRIAL INTERVENTIONS Preoperative course Intraoperative course Postoperative course TREATMENTS PERMITTED AND NOT PERMITTED SPECIFICATION AND ASSESSMENT OF THE EFFICACY PARAMETERS PROPOSED SAMPLE SIZE ASSESSMENT OF SAFETY Specification of Safety Parameters Methods and timing for assessing, recording and reporting adverse events Emergency Procedures Procedure for eliciting reports of and for recording and reporting adverse events EXPECTED TRIAL DURATION STATISTICS STATISTICAL METHODS NUMBER OF PATIENTS POTENTIAL FOR RECRUITMENT OF SUITABLE PAITENTS ANALYSIS ANALYSIS POPULATIONS DISPACT TRIAL Amendment II 18. Januar 2007 page 2 of 62

3 5 ETHICAL CONSIDERATIONS APPROVAL OF THE CLINICAL TRIAL PROTOCOL AND AMENDMENTS RISK-/ BENEFIT RATIO FOR PARTICIPANTS DECLARATIONS SUBJECT INFORMATION AND INFORMED CONSENT OPINION FROM THE ETHICS COMMITTEE TRIAL MANGEMENT AND ORGANIZATION STUDY COORDINATION AND DATA MANAGEMENT EXPERTISE OF THOSE RESPONSIBLE FOR THE TRIAL SUPPORTING INFRASTRUCTURE OF THE MEDICAL INSTITUTION(S) INDEPENDENT BIOMETRICIAN COMMITTEES Steering Committee Data and Safety Monitoring Board (DSMB) Data Verification Committee Adverse Event Committee MONITORING AND QUALITY ASSURANCE QUALITY CONTROL AND QUALITY ASSURANCE MONITORING DATA HANDLING AND RECORD KEEPING Direct access to source data / documents Handling of missing, unused and spurious data PROCEDURES FOR REPORTING DEVIATIONS FROM THE STATISTICAL PLAN MAINTENANCE OF TRIAL TREATMENT RANDOMIZATION CODES AND PROCEDURES FOR UNBLINDING CRITERIA FOR TERMINATION OF THE TRIAL REFERENCES SUPPLEMENTS SIGNATURE SHEET PUBLICATION POLICY AUTHORS CONTRIBUTIONS: CONFLICTS OF INTEREST AGREEMENTS CO-FINANCING BY INDUSTRY AND / OR OTHER THIRD PARTIES PATIENT INSURANCE INFORMED CONSENT STANDARD SURGICAL PROCEDURES OF DISTAL PANCREATECTOMY OPERATION MANUAL SCREEN LOG DISPACT-TRIAL FINANCIAL PLAN DISPACT TRIAL Amendment II 18. Januar 2007 page 3 of 62

4 1 GENERAL INFORMATION 1.1 Title of the Trial Distal Pancreatectomy A randomized controlled trial to compare two different surgical techniques - DISPACT-TRIAL. 1.2 Coordinating / Principle investigator Prof. Markus W. Büchler Chairman Department of Surgery University of Heidelberg, Medical School Im Neuenheimer Feld Heidelberg Germany Telephone Fax Scientific discipline and field of work The DISPACT-TRIAL is a project of the Study Center of the German Surgical Society (SDGC), Heidelberg, Germany. The topic of this trial refers to the field of visceral surgery. 1.4 Scheduled duration The projected start and inclusion of the first patient is May 1 st Thenceforward, the scheduled duration is planned to be 54 months from start of recruitment to the reporting of the final results. The total duration of the trial results from a scheduled recruitment time of 36 months and a consecutive 12 month follow up. Three months after completion of follow up the database will be closed with a consecutive final analysis (three months). 1.5 Staff and institution s contribution This multi-center trial is supported by the Study Centre of the German Surgical Society (SDGC). DISPACT TRIAL Amendment II 18. Januar 2007 page 4 of 62

5 1.6 Funding Protocol development University of Heidelberg, Medical School Heidelberg, Germany Trial implementation, personal, management and infrastructure Study Centre of the German Sugrical Society (SDGC) University of Heidelberg Im Neuenheimer Feld Heidelberg Surgical material Study Material (staplers and suture material) will be supplied by ETHICON. The company neither had influence on the protocol development nor will have on the conduct and analysis of the trial results. 1.7 Registration Registration of the trial will be processed immediately upon receipt of a positive vote of the local independend ethics commitee to receive an International Standard Randomised Controlled Trial Number (ISRCTN; The assigned ISRCTN number from the Current Controlled Trials register is as followed: ISRCTN DISPACT TRIAL Amendment II 18. Januar 2007 page 5 of 62

6 1.8 Investigators, Sponsor, Biometrician and monitor Coordinating Investigator Prof. Markus W. Büchler Chairman Department of Surgery University of Heidelberg, Medical School Im Neuenheimer Feld Heidelberg Germany Telephone Fax Investigators of participating centers Heidelberg: Dr. med. Markus K. Diener Telephone Handy Fax Marburg Prof. Dr. M. Rothmund Hamburg: Prof. Dr. J. Izbicki Berlin: Prof. Dr. P. Neuhaus Dresden: Prof. Dr. H. D. Saeger Bochum: Prof. Dr. W. Uhl Freiburg: Prof. Dr. U. Hopt Mannheim: Prof. Dr. St. Post Leipzig: Prof. Dr. H. Witzigmann Amsterdam: Prof. Dr. D. Gouma Liverpool: Prof. Dr. J. Neoptolemos Ljubljana: Prof Dr. S. Repse Rostock: Prof. Dr. E. Klar Berlin: Prof. Dr. J. Müller München-Großhadern: Prof. Dr. K. W. Jauch Homburg/Saar: Prof. Dr. M. Schilling Ulm: Prof. Dr. D. Henne-Bruns Düsseldorf: Prof. Dr. B. Ulrich Regensburg: Prof. Dr. H. J. Schlitt Stockholm: Prof. Dr. J. Permert Utrecht: Prof. Dr. H. Gooszen Bern: Prof. Dr. D. Candinas Verona: Prof. Dr. C. Bassi DISPACT TRIAL Amendment II 18. Januar 2007 page 6 of 62

7 Independent Biometrician Dipl.-Inform. Med. A. Deckert Institute for Medical Biometrics and Informatics Im Neuenheimer Feld Heidelberg Germany Telephone Fax Data Management / SAE Management Cooperation unit of the Study Center of the German Surgical Society (SDGC) and the Institute of Medical Biometry and Informatics (IMBI) University of Heidelberg, Medical School Im Neuenheimer Feld Heidelberg Germany Telephone: Fax: Sponsor Principal Sponsor Trial implementation, personal, management, analysis and infrastructure: Federal Ministry for Education and Research (BMBF) Heinrich-Konen-Straße Bonn Protocol development: Study Centre of the German Surgical Society (SDGC) Study Material (staplers and suture material): ETHICON Products Germany GmbH Robert-Koch-Str Norderstedt Germany General Contact / Information Responsible Biometrician Dr. sc. hum. S. Witte Institute for Medical Biometrics and Informatics, SDGC Im Neuenheimer Feld Heidelberg Germany Telephone Fax Monitoring Coordinating Centre for Clincal Trials KKS Heidelberg University of Heidelberg Im Neuenheimer Feld Heidelberg Germany Tel.: Fax: DISPACT TRIAL Amendment II 18. Januar 2007 page 7 of 62

8 Study Centre of the German Surgical Society (SDGC) Department of Surgery University of Heidelberg Im Neuenheimer Feld Heidelberg Germany Telephone: Fax: DISPACT TRIAL Amendment II 18. Januar 2007 page 8 of 62

9 1.9 Overview trial design and implementation Population Hospitalized patients, planned for elective resection of the pancreatic tail due to chronic pancreatitis, benign tumors, malignant tumors, neuroendocrine tumors and cysts. Screening day of admission Inclusion/exclusion criteria Not eligible Refuse participation Eligible Informed consent/ enrolment Day of operation Day 7 post OP Day of discharge Randomization (preop.) Stapling vs. hand-sewn closure Primary and secondary endpoints Day 30 post OP (phone) Primary and secondary endpoints 12 months post OP (phone) Primary and secondary endpoints Survival DISPACT TRIAL Amendment II 18. Januar 2007 page 9 of 62

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11 1.10 Flowchart Course of examinations Visit 1 (=Screening) 2 (OP =day0) 3 (day 7 post OP) 4 (day of discharge) 5 (day 30 post OP) by phone 6 (12 months post OP) by phone Past and current medical history X Informed consent X Physical examination / personal data X Basic study-related examination (for each primary and X X X X X secondary endpoint,) AE, SAE X X X X X Grade of fibrosis X Drainage parameters X X Laboratory X X X parameters Medication X Endocrine function X X X Survival X X X X X Past and current medical history: past and current medical and surgical history, indication for operation Personal data: height in cm, weight in kg, age, gender, smoking habits Basic study related examination: physical examination for each secondary endpoint or adverse event/serious adverse event Physical examination: vital signs (blood pressure systolic/diastolic in mmhg, heartrate in /min) Grade of fibrosis: measured by central laboratory of the European Pancreatic Center (EPZ), Dept. of Surgery, University of Heidelberg Laboratory parameters: serum chemistry, clotting, hematology, endocrinology Drainage parameters: Amylase activity in drain fluid output, clinical grading Endocrine function: Serum glucose level Visit 5: by phone; performed by participating centers Visit 6: by phone; performed by participating centers In case of an extra visit performed by the investigator primary and/or secondary outcomes may be reached, AE/SAE form may be necessary. DISPACT TRIAL Amendment II 18. Januar 2007 page 11 of 62

12 1.11 Summary Title of trial Distal Pancreatectomy A randomized controlled trial to compare two different surgical techniques (Acronym) DISPACT-TRIAL Disease or condition Patients with diseases of the pancreatic body and tail undergoing elective distal pancreatectomy due to: resectable malignant, non-malignant and neuroendocrine tumours of the pancreas (high risk level), resectable chronic pancreatitis and pseudocysts (low risk level). Design / methodology This is a multi-center, pre-operatively randomized, controlled and patient and observer blinded trial performed as a parallel group adaptive superiority design. The randomization is done stratified for centers and risk level (low/high). The patient is blinded for the technique used in order to prevent an impact on secondary endpoints. Topic / objectives / aim The trial is designed to show that the risk of developing a pancreatic fistula and/or death until day 7 after the surgical procedure can be reduced by stapler-closure of the pancreatic remnant compared to scalpel transsection and hand-sewn suture following distal pancreatectomy. Eligibility criteria - Age equal or above 18 years inclusion Expected survival time more than 12 months Patients with at least one of the following pathologic diseases scheduled for elective resection: - Resectable malignancies of the pancreatic body and/or tail - Resectable chronic pancreatitis of the body and/or tail - Resectable benign tumours of the pancreas including neuroendocrine tumours - Resectable pseudocyst of the pancreatic body and/or tail Eligibility criteria - Current immunosuppressive therapy exclusion Chemotherapy within 2 weeks before operation Radiotherapy within 8 weeks before operation Curative resection is not feasible Severe psychiatric or neurologic diseases Drug- and/or alcohol-abuse according to local standards Participation in another intervention-trial with interference of intervention or outcome Inability to follow the instructions given by the investigator or interviewer Expected lack of compliance Lack of informed consent Groups / interventions A standardized surgical abdominal approach is performed in both groups with a stapler-resection / -closure versus scalpel transsection and hand-sewn closure of the pancreatic tail. Endpoints / primary outcome(s) Combined primary endpoint: presence of a pancreatic fistula and / or death due to any cause on day 7 postoperatively. Secondary endpoints: operating time, frequencies of burst abdomen, wound infection, and intraabdominal fluid collection and abscess, postoperative length of hospital stay, new onset of diabetes mellitus, one-year survival. Sample size A total of approximately 550 patients may be included with an expected preoperative drop out rate of 100 patients. Thus, 450 patients will be randomized to accumulate 151 patients in both groups respectively for analyses (assumed protocol violations / lost to follow-up per group: 74 patients) The sample size will be recalculated after an interim analysis when 112 patients per arm are evaluable. Trial duration Duration of enrolment: 36 months Interim analysis: after about 29 months Duration of treatment: Day of Surgery Duration of follow-up: 1 month for adverse events 12 months for survival End of follow-up period: 12 months after recruitment of the last patient Duration of analysis and reporting: The database will be closed 6 months after the end of follow up. Evaluations and reporting will be finished 6 months thereafter. DISPACT TRIAL Amendment II 18. Januar 2007 page 12 of 62

13 Principal / coordinating investigator PI / CI Address Street Zip City/town Tel Fax Prof. Markus W. Büchler Chairman Department of General-, Visceral and Trauma Surgery University of Heidelberg, Medical School Im Neuenheimer Feld Heidelberg Germany Telephone Fax Abbreviations and definitions CRF Case Report Form ecrf electronic Case Report Form GCP Good Clinical Practice ICH International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use IRB Institutional Review Board RCT Randomized controlled trial SDGC Study Center of the German Surgical Society (Studienzentrum der Deutschen Gesellschaft für Chirurgie) KKS Coordinating Center for Clinical Trials (Koordinierungszentren für Klinische Studien) IMBI Institute for Medical Biometrics and Informatics (Institut für Medizinische Biometrie und Informatik) EPZ European Pancreas Centre (Europäisches Pankreas Zentrum) CI Confidence interval OR Odds ratio DSMB Date Safety and Monitoring Board ARR Absolute Risk Reduction RRR Relative Risk Reduction SOC System Organ Class. DISPACT TRIAL Amendment II 18. Januar 2007 page 13 of 62

14 2 The medical problem 2.1 Evidence After distal pancreatectomy, the appropriate closure of the remnant is still debated. All resections of this endocrine organ to the left side of the superior mesenteric vein are defined as distal pancreatectomy. Distal pancreatic resections are performed less frequently (15% of all pancreatic resections in Heidelberg) compared to resections of the head due to lower incidence and later appearance of clinical symptoms 1. Nevertheless, the improving imaging and diagnostic techniques account for an increase in frequency of distal pancreatic resections due to pancreatic disease. Most patients (84%) are treated as elective cases for the following indications: chronic pancreatitis (24%), other benign diseases (22%), malignant diseases (18%), neuroendocrine tumours (14%), and cysts of the pancreas (6%). The remaining 16% are emergency cases after abdominal trauma 2. In the past years, mortality after pancreatic resections has decreased considerably in high volume centers, with still a high morbidity 3,4. Pancreatic fistula and leakage are the most common and most relevant complications due to surgical technique and skill 1,5-8. The major complication after distal pancreatectomy is the occurrence of a pancreatic fistula. Since fistulae are associated with local and general complications (pancreatic fluid collection, formation of intra-abdominal abscesses, wound infection, delayed gastric emptying, respiratory complications, sepsis and bleeding), they have several relevant implications for the patient, the surgeon and the health care system. This morbidity causes a prolongation of hospital stay due to the additional need for specialised treatment including invasive procedures such as additional surgery or interventional drainage 2,9,10. A recent systematic review and meta-analysis 11 evaluated all available surgical techniques of distal pancreatectomy, in particular with regard to the occurrence of pancreatic fistulae: handsewn suture techniques versus stapled closure and combination of both 5-7,12-15, ultrasonic dissection devices 16, pancreatico-enteric anastomosis 8,12, application of meshes 12, or sealing by use of fibrin glue 7,17. As expected, stapler-closure and hand-sewn closure of the pancreas were found to be the most common techniques. The reported postoperative morbidity varies between 13.2% and 64%. The primary outcome measure, pancreatic fistula, occurred within a range from 0% - 61%. Meta-analysis of stapler versus hand-sutured closure (one RCT; five observational studies 5-7,12-14 ) showed a nonsignificant (P = 0.21) combined odds ratio for the occurrence of a pancreatic fistula of 0.66 (95 % confidence interval 0.35 to 1.26) in favour of stapler-closure (Fig. 1). DISPACT TRIAL Amendment II 18. Januar 2007 page 14 of 62

15 2.2 The need for a trial Given the results of the systematic review, the quality and quantity of information extracted from the trials performed are still insufficient to draw any firm conclusions on the optimal choice of surgical technique to close the pancreatic stump. To prove the appropriateness of stapler-transsection and closure of the pancreatic remnant as a standard will influence the future surgical techniques in distal pancreatectomy and general health care. This technique has to be compared with the reference treatment of the hand-sewn closure of the pancreatic tail. In order to generate unbiased and valid data and due to rare pancreatic left resections, this question has to be answered in a prospective, randomized-controlled multi-center trial using the frequency of pancreatic fistula and/or mortality as primary endpoint. Review: Comparison: Outcome: Closure Technique of the Pancreatic Remannt after Distal Pancreatectomy - Systematic Review and Meta-analysis 01 Stapler-closure vs. suture-closure in distal pancreatectomy 01 Pancreatic fistula Study Stapler Suture OR (random) Weight OR (random) or sub-category n/n n/n 95% CI % 95% CI Year Quality Kajiyama et al. 14/35 80/ [0.38, 1.66] 1996 D Fahy et al. 3/23 10/ [0.06, 1.14] 2002 D Sheehan et al. 4/16 5/ [0.49, 9.30] 2002 D Bilimoria et al. 4/20 18/ [0.27, 3.04] 2003 D Takeuchi et al. 0/10 8/ [0.00, 1.67] 2003 D Bassi et al. 2/14 5/ [0.05, 2.10] 2004 B Total (95% CI) [0.35, 1.26] Total events: 27 (Stapler), 126 (Suture) Test for heterogeneity: Chi² = 6.78, df = 5 (P = 0.24), I² = 26.3% Test for overall effect: Z = 1.25 (P = 0.21) Favours Stapler Favours Suture Figure 1: Meta-analysis of closure techniques in distal pancreatectomy (Stapler-closure vs. Suture-closure) 11. The odds ratio estimates of occurrence of a pancreatic fistula for individual trials are shown in boxes calculated by the random effects model. Error bars indicate 95% CI. Summary of treatment effect is shown as a diamond that spans the 95% CI. Quality: Allocation concealment adequate (A); unclear (B); inadequate (C); not used (D) 2.3 Aim of the Trial A successfully conducted trial will have a positive impact on the future handling of the pancreatic remnant in distal pancreatectomy. The reliable and comparable data generated in this trial may support an evidence-based choice of a surgical technique out of a wide range of existing techniques. The reduction of the fistula rate, as the major complication of distal pancreatectomy, may lead to a decrease in further associated complications. In particular, the length of hospital stay and additional interventional procedures can be reduced and a return to full recovery will be accelerated. Additionally, costs of the post-operative treatment may be reduced as to the impact on the health care system. Moreover, this multi-center approach may DISPACT TRIAL Amendment II 18. Januar 2007 page 15 of 62

16 show that the introduced technique is appropriate for different settings and therefore shall be transferable to other health care institutions. After analysis and statistical evaluation, results will be published in a scientific medical journal. Publication of the trial protocol is in preparation. DISPACT TRIAL Amendment II 18. Januar 2007 page 16 of 62

17 3 Trial Design 3.1 Trial population Hospitalized patients with pancreatic disease, planned for an elective pancreatic tail resection. 3.2 Primary objective The trial is designed to show that the risk of developing a pancreatic fistula and/or death after the surgical procedure can be reduced by stapler-closure of the pancreatic remnant compared to scalpel transsection and hand-sewn suture following distal pancreatectomy. 3.3 Secondary objective Besides the occurence of a pancreatic fistula and/or death due to any cause a set of general and surgical parameters have to be analyzed in order to compare the two surgical approaches. In order to compare the effectiveness of both procedures adequately, relevant parameters of postoperative mortality and morbidity and survival will be analyzed (see 3.9). 3.4 Hypothesis The trial is designed to show that the risk of developing a pancreatic fistula and/or death after the surgical procedure can be reduced by stapler-closure compared to scalpel transsection and handsutured closure of the pancreatic remnant following distal pancreatectomy. The following hypothesis will be tested: H 0 : The risk of morbidity (pancreatic fistula) combined with mortality is equal in both groups. H 1 : The risk of morbidity (pancreatic fistula) combined with mortality is different between both groups. 3.5 Selection and withdrawal of patients Inclusion/Exclusion criteria Subject inclusion criteria Age equal or above 18 years Expected survival time more than 12 months Patients with at least one of the following pathologic diseases scheduled for elective resection: DISPACT TRIAL Amendment II 18. Januar 2007 page 17 of 62

18 Resectable malignancies of the pancreatic body and/or tail (e.g. all tumor that can be safely taken out after exploration (including splenectomy and other visceral organ removal), i.e. a potentially curative resection) Resectable chronic pancreatitis of the pancreatic body and/or tail Resectable benign tumours of the pancreatic body and/or tail including neuroendocrine tumours Resectable pseudocysts pancreatic body and/or tail Subject exclusion criteria Current immunosuppressive therapy (more than 40 mg of a corticoid per day or azathioprin) Chemotherapy within 2 weeks before operation Radiotherapy within 8 weeks before operation Curative resection is not feasible (e.g. palliative situation of disease) Severe psychiatric or neurologic diseases Drug- and/or alcohol-abuse according to local standards Participation in another intervention-trial with interference of intervention or outcome Inability to follow the instructions given by the investigator or the telephone interviewer (insufficient command of language, dementia, lack of time) Expected lack of compliance Lack of informed consent Subject withdrawal criteria Subjects may be withdrawn from the trial for the following reasons: Own request of the patient or at the request of their legally authorized representative Causes detrimental to the subject's well-being in the investigators opinion Non-resectable situation after the exploration of the abdomen. The documentation of withdrawal will be done on a seperate screening list of all patients. 3.6 Criteria for the selection of trial sites It is planned to include up to 20 highly specialized centers (performing at least 10 left resections of the pancreas/year) in Germany and other European countries. The participating centers will be checked for their expertise, particularly in distal pancreatectomy, prior to their enclosure. Moreover, the installation of a client-software (CITRIX) should be possible in order to assure access to ecrfs. DISPACT TRIAL Amendment II 18. Januar 2007 page 18 of 62

19 An initiation visit is planned to introduce the background, rationale and implementation of DISPACT-Trial in every single participating centre. 3.7 Primary and secondary endpoints Combined primary endpoint: Occurence of a pancreatic fistula (specification see ). Death due to any cause until the postoperative day 7 (specification see ). Secondary endpoints: Aside from the occurence of a pancreatic fistula, several parameters have to be analyzed in order to compare the two surgical approaches. The following secondary endpoints include general and specific surgical adverse events as well as parameters concerning the intraoperative and postoperative course of a patient (specification see ). 1. Surgical category Operating time [min] from resection to beginning of closure of the abdomen Total operating time [min] Frequency of burst abdomen Frequency of wound infection Frequency of intra-abdominal fluid collection rated as abscess that requires an intervention (surgery, drainage, antibiotic treatment) 2. Non-surgical category postoperative length of hospital stay Frequency of new onset diabetes mellitus (necessity of new anti-diabetic drug treatment) One-year survival 3.8 Methods against bias Several appropriate methods will be used to minimize bias. Randomization to one of the treatment groups by a central randomization system will generate comparable treatment groups by minimizing selection bias. Stratification for the participating centers will reduce bias by center effects. Stratification for the risk level (low/high) will differentiate patients with high risk (all tumors) and low risk (chronic pancreatitis) for development of a pancreatic fistula. The confirmatory analysis of the primary endpoint will be done stratified for the surgical expertise, to avoid a possible confounding effect. DISPACT TRIAL Amendment II 18. Januar 2007 page 19 of 62

20 All surgical procedures are easily applicable and well defined in detailed manuals. Equal treatment according to the specifications in the manual will reduce intra- and intervariability in pancreatic left resection. The investigation of the primary endpoint is based on objective measurements, which are exactly defined. Moreover, only centers that prove to be highly specialized for pancreatic resections (with at least 10 left resections of the pancreas per year) will be included in the trial Randomization A central randomization and registration system (www.randomizer.at) will be arranged in order to generate sufficient allocation concealment. Patients are randomized using the central randomization system before the surgical intervention is performed (at the latest before surgical skin incision) Stratification The randomization is done stratified for participating centers and risk level (low/high). Further stratification is planned for up to 20 participating highly specialized centers with at least 10 left resections of the pancreas per year Blinding The patient and the outcome assessor are blinded for the technique used. Thus, outcome assessment during all study visits has to be performed by a blinded clinical investigator and/or study nurse. Moreover, it is recommended to use the phrase resection in terms of distal pancreatectomy is performed according to randomization in the DISPACT-Trial in the operating report of enrolled and participating patients to maintain the blinding Confounding Moreover, the confirmatory analysis and reporting of primary and secondary endpoints will be grouped for the following parameters: Surgeon s expertise: - Low surgical expertise: 25 performed pancreatic resections during the last three years - Medium surgical expertise: performed pancreatic resections during the last three years - High surgical expertise: >50 pancreatic resection during the last three years DISPACT TRIAL Amendment II 18. Januar 2007 page 20 of 62

21 The number of previous operations (outside DISPACT-Trial) will be recorded for each surgeon. Thus a surgeon will not change the expertise group during the trial. 3.9 Trial Interventions Manuals of all surgical procedures will be provided for all participating centers (see 9.9) Preoperative course Randomization: Patients will be randomized preoperatively to one of the following surgical procedures: 1. Scalpel transsection of the pancreas and hand-sewn closure of the pancreatic remnant 2. Stapler-transsection of the pancreas and stapler-closure of the pancreatic remnant Randomization will be carried out preoperatively at the latest before surgical skin incision. Thus, preoperative randomization is considered to be adequate to control for selection bias Intraoperative course Standardized surgical abdominal approach: Abdominal approach can be achieved via median or transverse laparotomy according to local standards. A complete exploration of the abdomen is done including frozen sections to define potentially curative resection if necessary. The decision of splenectomy in addition to the planned/performed distal pancreatectomy will be made by the surgeon in accordance with the underlying disease of the patient and the curative intention. Scalpel transsection and hand-sewn closure of the pancreatic remnant: After complete mobilization of the pancreatic tail (up to the region of the superior mesenteric vein or at least 2-3 cms central of the planned resection margin), the resection is performed with a surgical scalpel. The subsequent closure of the pancreatic remnant is achieved with a separate stitched ligation of the pancreatic duct, followed by either a single-stitched or running suture closing of the entire pancreatic remnant. The suture material of choice should be a slowly absorbable monofilament thread, such as PDS or MonoPlus. A non-absorbable suture is neither required nor permitted for the hand-sewn closure of the transsected pancreas. The recommended suture strength is USP 4/0 and USP 5/0. No additional covering of the pancreatic remnant (e.g. Tachosil ) is permitted in this group. Stapler-closure: In the other group the mobilization of the pancreas is performed accordingly (up to the region of the superior mesenteric vein or at least 2-3 cms central of the planned resection margin). The DISPACT TRIAL Amendment II 18. Januar 2007 page 21 of 62

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