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Reinforced Pancreaticojejunostomy With or Without glubran2

ConditionsPancreatic FistulaPancreas CancerPeriampullary CarcinomaPancreatic Ductal Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMinia University

About this trial

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 .

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All the patients undergoing pancreaticoduodenectomy for cancer

Patients able to give their informed consent

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Reinforced pancreaticojejunostomy with tissue adhesive glue modified cyanoacrylate (glubran 2)

    Drug

    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.

  • Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2)

    Procedure/Surgery

    Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2)

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Reinforced pancreaticojejunostomy with tissue adhesive glue modified cyanoacrylate (glubran 2)Experimental treatment 1 intervention
Group B: Pancreaticojejunostomy without tissue adhesive glue modified cyanoacrylate (glubran 2)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

the rate of Postoperative pancreatic fistula 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.

Time frame
within 2 weeks after operation

Secondary outcomes

1

Post-Pancreatectomy Hemorrhage

As defined by the International Study Group for Pancreatic Surgery (ISGPS), grade A, B and C rates

Time frame
90 days
2

Delayed Gastric Emptying

As defined by ISGPS, grade A, B and C rates

Time frame
90 days
3

Biliary fistula

Output of bile from drains on or by post operative day 3, pancreaticojejunostomy leak should be ruled out

Time frame
90 days
4

Abdominal abscess

Collection \>5cm in size, containing gas bubbles, determining systemic signs of infection

Time frame
90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Minia University

Lead sponsor

Source ClinicalTrials.gov
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