Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000481673
Ethics application status
Approved
Date submitted
10/04/2014
Date registered
9/05/2014
Date last updated
9/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
A new modification of pancreaticogastrostomy after pancreaticoduodenectomy for patients with cancer head pancreas with possible less formation of post operative pancreatic fistula formation.
Scientific title
Evaluation of a new modification of pancreaticogastrostomy after pancreaticoduodenectomy: anastomosis of the pancreatic duct to the gastric mucosa with invaginatation of the pancreatic remnant end into the posterior gastric wall for patients with cancer head pancreas in terms of post operative pancreatic fistula formation.
Secondary ID [1] 284412 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pancreatic cancer 291612 0
Condition category
Condition code
Surgery 291985 291985 0 0
Surgical techniques
Cancer 292061 292061 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A new modification of pancreaticogastrostomy after pancreaticoduodenectomy: anastomosis of the pancreatic duct to the gastric mucosa with invaginatation of the pancreatic remnant end into the posterior gastric wall.
Operative technique: Pancreaticoduodenectomy was performed in a classical technique using (linear cutter TRT75 , green, Ethicon (Registered Trademark)) to cut at the neck of the pancreas. Very few cases required further hemostasis as using the linear cutter was very effective to control bleeding from the pancreatic edge. The pancreatic remnant was mobilized 2 to 3 cm from the splenic vein and the surrounding tissues. After removal of one or two staples and identification of the pancreatic duct, a 10 or 12 Fr. polyethylene catheter passed into the main pancreatic duct to ensure its patency. The catheter was cut 1 cm. from the pancreatic edge. Then a stab 5mm. transverse full thickness incision was made on the posterior wall of the stomach opposite to the pancreatic duct end . A purse string suture was made in the posterior gastric wall around the opening in the posterior gastric wall using 2-0 polypropylene sutures, with a distance between the purse suture and the opening 1.5 times the distance between the pancreatic duct and the upper edge of the pancreas. The purse string suture was left loose. Next, anastomosis between the pancreatic duct and the gastric mucosa was done using four 4-0 polypropylene sutures at the four quarters. The polyethylene catheter passes into the stomach through the pancreaticogastrostomy and left to be dropped spontaneously. Four 3-0 polyglactin sutures were secured between the capsule of the pancreas (1 cm. from the edge) and the seromascular layer of the posterior wall of the stomach. In cases of soft pancreas, the pancreatic sutures were taken a little bit deeper. Care must be taken that the posterior suture must be done and kept loose before the anastomosis between the pancreatic duct and the gastric mucosa as the field will be blocked by the anastomosis and will make taking this suture very difficult and hazardous. Then, the posterior wall of the stomach is wrapped around the pancreatic remnant while the purse string is tightened to ensure invagination of the pancreatic remnant. This maneuver should be performed very gently to ensure tight wrapping of the posterior gastric wall around the pancreatic remnant and to avoid any tension over the anastomosis between the pancreatic duct and the gastric mucosa. Further reconstruction of digestive continuity was obtained by end-to-side hepaticojejunostomy, and side-to-side stapled gastrojejonostomy. All patients had two closed suction drains placed at the time of operation, one in close proximity to the pancreatic anastomosis and the other in the pelvis. duration of the procedure is from 3 - 6 hours.
Intervention code [1] 289160 0
Treatment: Surgery
Comparator / control treatment
Data collected from the literature as regards Standard technique by anastomosing the pancreatic duct to gastric mucosa using 4 polypropelene 4-0 sutures in the four quadrants. Duration of the procedure is from 3 - 6 hours.
(Telford, G L and Mason, G R. Pancreaticogastrostomy :Clinical Experience With a Direct Pancreatic-Duct-to-Gastric-Mucosa Anastomosis. American journal of surgery, ISSN 0002-9610, 06/1984, Volume 147, Issue 6, pp. 832 - 837 .)
Control group
Historical

Outcomes
Primary outcome [1] 291884 0
Incidence of post operative pancreatic fistula
Timepoint [1] 291884 0
on 5th postoperative day, while the patient is still hospitalized, a sample from serum of the patient and a sample from the drain fluid will be taken and when amylase of the drained fluid is three times higher than the serum amylase the diagnosis of post operative pancreatic fistula is confirmed.
Secondary outcome [1] 307733 0
rate of mortality
Timepoint [1] 307733 0
Mortality rate up to discharge from the hospital reported by the doctor
Secondary outcome [2] 307879 0
Early postoperative complications (wound infection)
Timepoint [2] 307879 0
Diagnosed and reported by the doctor during hospital stay and up to one month post operative period when there is erythema within 1 cm of the wound as superficial wound infection. When there is pus discharging from the wound, it will be considered deep wound infection
Secondary outcome [3] 307880 0
Hospital stay
Timepoint [3] 307880 0
Hospital stay calculated in days from date of operation till date of discharge and reported by the doctor.
Secondary outcome [4] 307881 0
Early postoperative complications (delayed gastric emptying)
Timepoint [4] 307881 0
Diagnosed and reported by the doctor when the patient can not tolerate normal feeding till after 10 days in the post operative period
Secondary outcome [5] 307882 0
Early postoperative complications (hemorrhage)
Timepoint [5] 307882 0
Diagnosed and reported by the doctor when there is bleeding from the drains or drop in hemoglobin level of the patient more than 2 mg/dl in 24 hours associated with hemodynamic instability during the period from the operation time till patient is discharged
Secondary outcome [6] 307883 0
early postoperative complications (biliary leak)
Timepoint [6] 307883 0
Diagnosed and reported by the doctor by noticing bile in the drain fluid or coming from the wound from the operation time till patient is discharged from the hospital. biliary fistula is documented if the bile leak continues for 5 days or more

Eligibility
Key inclusion criteria
Patients with operable periampullary carcinoma and cancer head of the pancreas
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inoperable cases with periampullary carcinoma and cancer head of the pancreas whether diagnosed preoperatively or intra-operatively were offered palliative stenting or bypass surgery and excluded from the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
all patients who were operated by elective pancreaticoduodenectomy with pancreatico-gastrostomy in Alexandria Main University Hospital, Alexandria, Egypt
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The statistical analysis of data done by using excel program for figures and SPSS (SPSS, Inc, Chicago, IL) program statistical package for social science version 17. The description of data done in form of mean (+/-) SD for quantitative data and frequency & proportion for Qualitative data. Chi square test and more accurate Fisher Exact test was selected for qualitative data and odds ratio for risk assessment. P is significant if equals 0.05 at confidence interval 95%.
Sample size calculation was based on a error of 0.05, power of 0.80 using G power program version 3.1.3 2007
as the wide range of incidence of postoperative pancreatic fistula (0 - 17%), calculation revealed that any sample size will give valid results.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
18/02/2009
Date of last participant enrolment
Anticipated
Actual
11/06/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 5978 0
Egypt
State/province [1] 5978 0
Alexandria

Funding & Sponsors
Funding source category [1] 289062 0
Hospital
Name [1] 289062 0
Alexandria Main University Hospital
Country [1] 289062 0
Egypt
Primary sponsor type
Hospital
Name
Alexandria Main University Hospital
Address
Department of General Surgery. 1 Kolleyet Al Teb st. Azareeta, Alexandria, Egypt. 21526
Country
Egypt
Secondary sponsor category [1] 287728 0
None
Name [1] 287728 0
Address [1] 287728 0
Country [1] 287728 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
the study aims to evaluate a new modification of reconstruction of the alimentary tract after excision of cancer head pancreas to decrease incidence of post operative pancreatic leak which is the main factor determining morbidity and even mortality after the operation
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47618 0
Dr Mohamed Mazloum Osman MD
Address 47618 0
Assistant Professor, General Surgery Department, Faculty of Medicine, Alexandria University. Chamblion street, el azareeta, Alexandria Governorate, Egypt. 21526
Country 47618 0
Egypt
Phone 47618 0
+20 1121721722
Fax 47618 0
Email 47618 0
[email protected]
Contact person for public queries
Name 47619 0
Walid Abd El Maksoud MD, MRCS
Address 47619 0
Assistant Professor, General Surgery Department, Faculty of Medicine, Alexandria University. Chamblion street, el azareeta, Alexandria Governorate, Egypt. 21526
Country 47619 0
Egypt
Phone 47619 0
+20 1211433351
Fax 47619 0
Email 47619 0
[email protected]
Contact person for scientific queries
Name 47620 0
Walid Abd El Maksoud MD, MRCS
Address 47620 0
Assistant Professor, General Surgery Department, Faculty of Medicine, Alexandria University. Chamblion street, el azareeta, Alexandria Governorate, Egypt. 21526
Country 47620 0
Egypt
Phone 47620 0
+20 1211433351
Fax 47620 0
Email 47620 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIEvaluation of a New Modification of Pancreaticogastrostomy after Pancreaticoduodenectomy: Anastomosis of the Pancreatic Duct to the Gastric Mucosa with Invagination of the Pancreatic Remnant End into the Posterior Gastric Wall for Patients with Cancer Head of Pancreas and Periampullary Carcinoma in terms of Postoperative Pancreatic Fistula Formation2014https://doi.org/10.1155/2014/490386
N.B. These documents automatically identified may not have been verified by the study sponsor.