Pancreas Cancer, Pancreatic Ductal Adenocarcinoma, Pancreatic Fistula, Periampullary Carcinoma
Conditions
Brief summary
Pancreatic fistula is one of the most serious complication after pancreatoduodenectomy. To reduce pancreatic fistula, many authors recommend different techniques in pancreatojejunostomy. The purpose of this study is to determine which is the best method in preventing pancreatic fistula by enforce pancreaticojejunostomy with tissue glue .
Detailed description
Tissue adhesives have gained popularity in various fields of surgical practice. There are various types of tissue adhesives, each with their own adhesive mechanisms and uses. Basically, a tissue adhesive forms bonds with its substrate, ensuring sufficient adhesion. These bonds can either be chemical, of which covalent bonds are the strongest, or physical, including hydrogen bonds or van der Waals forces. Furthermore, the total strength of the glue bond depends on the balance between interaction within the tissue adhesive (cohesion) and between the tissue adhesive-substrate interface (adhesion). Tissue adhesives can either be glues, intended to independently connect various structures (i.e., wound edges), or sealants, used to cover and protect an anastomosis . Except for external use, tissue adhesives can also be used intracorporeally. Various tissue adhesives are being used in cardiovascular surgery, plastic surgery, and, increasingly, surgery of the GI tract . Tissue adhesives are promising tools for wound closure. They distribute forces throughout the wound more evenly and noninvasively than sutures and staples, are strong and flexible, and do not interfere with the wound-healing process. Also, the technique of tissue adhesive application to the wound is easy and standardizable, resulting in less variation in technique between surgeons . By using tissue adhesives as sealants of GI anastomosis, enhancing standard anastomotic techniques. Numerous research projects have been undertaken to assess the applicability of available tissue adhesives in GI surgery; however, no recent literature provides the surgical community with an up-to-date overview of the progress in this field . •After being informed about the study and potential risks, all patients giving written consent. Eligible patients were randomly assigned in a 1:1 ratio to either the Glubran®2 group (Group A) or the Control group (Group B) using a computer-generated randomization sequence with permuted blocks of 4 and 6. Allocation concealment was ensured using serially numbered, opaque, sealed envelopes prepared by an independent statistician. Each envelope was opened by the scrub nurse or anesthesiologist immediately after the completion of the pancreaticojejunostomy anastomosis, before final hemostasis and abdominal closure
Interventions
DRUGReinforced pancreaticojejunostomy with tissue adhesive glue modified cyanoacrylate (glubran 2)
pancreaticojejunostomy was done with application of glubran 2: The blister pack was opened, and the sterile single-dose vial was released directly onto the operating table in a sterile environment, Draw the Glubran 2 out of the single-dose vial using a sterile syringe then put the syringe into applicator Glubran 2 was applied into anastomosis by applicator in spraying manner . Whenever possible, the area to be treated should be cleaned before application. When applied in such a minimal amount, once it had polymerized, Glubran 2 formed a thin adhesive layer. It was therefore essential not to apply more than one drop in the same point. A second layer of Glubran 2 may not be applied until the first had polymerized. Any excess product was removed using a dry swab within 5-6 seconds after application. Glubran 2 was not touched after application until the polymerization reaction is complete, as it may detach or not produce the desired effect.
PROCEDUREPancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2)
Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2)
Sponsors
Minia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
Surgeons are not blinded due to the intervention's nature; care provider , assessors, and analysts are blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* All the patients undergoing pancreaticoduodenectomy for cancer * Patients able to give their informed consent
Exclusion criteria
* Unfit patients for surgery due to severe medical illness. * Inoperable patients by imaging studies, irresectable tumors after laparotomy or diagnostic laparoscopy. * Presence of distant metastasis . * Patients refused to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the rate of Postoperative pancreatic fistula within 2 weeks after operation | within 2 weeks after operation | Postoperative pancreatic fistula (POPF) is defined as a drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-Pancreatectomy Hemorrhage | 90 days | As defined by the International Study Group for Pancreatic Surgery (ISGPS), grade A, B and C rates |
| Delayed Gastric Emptying | 90 days | As defined by ISGPS, grade A, B and C rates |
| Biliary fistula | 90 days | Output of bile from drains on or by post operative day 3, pancreaticojejunostomy leak should be ruled out |
| Abdominal abscess | 90 days | Collection \>5cm in size, containing gas bubbles, determining systemic signs of infection |
| Acute pancreatitis | 1 day post index surgery | Altered serum amylase count on post operative day 0 or 1 |
| Wound infection | 90 days | Superficial and Deep Surgical Site Incisional Infection as defined by the Center for Disease Control and Prevention |
| Blood transfusions | 90 days | Need and number of packed red blood cells transfused |
| Reoperation | 90 days | Need for new surgery due to severe morbidity |
| Readmission | 30 days after hospital discharge | New admission within 30-days of discharge from hospital |
| Length of Hospital Stay | 1 year | calculated from the day of surgery to the day of discharge, adding up the days after a possible re-admission |
| Mortality | 90 days | Death related to surgical morbidity |
| Removal time of drain | From date of surgery until the date of the last drainage removal, whichever came first, assessed up to study completion, an average of 1 year | The timing of removal of the drain tube is determined based on the time of removal of the last drain tube. The removal of the drain tube is assessed at the discretion of the surgeon. |
Countries
Egypt
Contacts
CONTACTSaleh K Saleh, MD
PRINCIPAL_INVESTIGATORSaleh K Saleh, MD
Minia University
Outcome results
None listed