Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202201648766761 Date of Approval: 17/01/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Minimal invasive Cystogastrostomy
Official scientific title Laparoscopic Versus Endoscopic Cystogastrostomy for Pancreatic Pseudocysts: a Short Term Egyptian Multicenter Experience
Brief summary describing the background and objectives of the trial Internal drainage of large persistent pancreatic pseudocysts (PPs) is the main management modality. Minimal invasive approaches are preferred than open one for drainage. Endoscopic drainage guided by endoscopic ultrasound began to be involved in drainage approaches. The aim of this study was to compare the short-term success rate and morbidity between laparoscopic and endoscopic Cystogastrostomy .
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/05/2017
Actual trial start date
Anticipated date of last follow up 31/07/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 44
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group laparoscopic cystogastrostomy 4 years laparoscopic cystogastrostomy, abdominal insufflation, anterior gastrostomy, puncture of retrogastric cyst , widening the opening by stapler, necrosectomy, closure of anterior gastrostomy 20
Control Group Endoscopic cystogasrostomy 4 years puncturing of the cyst wall was achieved in all cases using 19-gauge fine needle aspiration needle under guidance of the Doppler-ultrasound, followed by confirmatory aspiration of the content. Then, a 0.035-inch guide wire was inserted through the needle into the pseudocyst lumen forming 2-3 coils under both EUS and fluoroscopy guidance to prevent any potential dislodgment. Furthermore, graded dilatation of the needle tract was achieved using electrocautery (6 or 10 Fr cystotome or needle knife) followed by dilatation using either 10 Fr Soehendra dilator (Soehendra® Biliary Dilation Catheter) or dilatation balloon of different sizes, 10-11-12 or 12-13.5-15 Fr (Cook® Hercules Dilation Balloon or Boston Scientific® CRE balloon). Finally, under the guidance of EUS and fluoroscopy, a wide caliber, 10 Fr double pigtail plastic stent was deployed over the guidewire into the cyst 24 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Symptomatic cyst Presented 6 weeks or more after the last attack of acute pancreatitis Cysts more than 6 cm in diameter ( Located at the lesser sac < 1 cm away from the gastric wall Well matured wall . Patients with suspected true pancreatic cysts Patients with coagulopathy or unfit for general anesthesia Patients who did not complete the 6 months follow up period Cysts with any previous intervention Walled of necrosis containing > 30% of necrotic debris Complicated cysts as abscess, intracystic bleeding and pseudo aneurysm. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/11/2021 General surgery department
Ethics Committee Address
Street address City Postal code Country
Ramsis street Cairo 002 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary success rate of the procedure, which was defined as successful completion of technique plus resolution of the cyst (defined as relief of the symptoms and no residual collection more than 50% of the initial amount after 4 weeks from the procedure). Overall clinical success rate was defined as no recurrence of the collection or symptoms after 6 months even after additional procedures. After 4 weeks from the procedure then after 6 months
Secondary Outcome Intraoperative data (duration of the procedure, intraoperative blood loss, gastric perforation, bowel injury) and postoperative data as hospital stay, postoperative complication (gastric ileus, hemorrhage, and surgical site infection), stent migration and mortality rate. Intraoperative and postoperative up to 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University Hospitals Ramsis street Cairo 002 Egypt
Mansoura University Hospitals Elgomhoria street Mansoura 002 Egypt
Cairo University Hospitals Kasr al-Aini street Cairo 002 Egypt
Theodor Bilharz Research Institute El-Nile street Cairo 002 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Hossam Sobhy Abdelrahim Ramsis street Cairo 002 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Authors with no external sponsorship Ramsis street Cairo 002 Egypt Authors
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hossam S Abdelrahim hosam_l_n@yahoo.com 00201110540267 Ramsis street
City Postal code Country Position/Affiliation
cairo 002 Egypt Lecturer of general surgery
Role Name Email Phone Street address
Public Enquiries Ahmed F Amer drfo2sh@hotmail.com 00201006208888 Ramsis street
City Postal code Country Position/Affiliation
Cairo 002 Egypt Lecturer of general surgery
Role Name Email Phone Street address
Scientific Enquiries Wadie Gerges wadie.boshra@med.asu.edu.eg 00201222795940 Ramsis street
City Postal code Country Position/Affiliation
Cairo 002 Egypt Assistant professor of general surgery
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data are restricted not allowed for sharing Informed Consent Form Our data are restricted Controlled access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Hosam_l_n@yahoo.com No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information