New Technique of Pancreaticojejunostomy During Whipple Operation
NCT ID: NCT06630910
Last Updated: 2024-10-08
Study Results
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Basic Information
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COMPLETED
PHASE4
48 participants
INTERVENTIONAL
2022-03-10
2024-03-10
Brief Summary
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Detailed Description
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A traditional pancreaticoduodenectomy with pylorus preservation was performed on each patient. Every patient had reconstruction utilizing a single jejunal loop after resection, which was made possible by various anastomoses. A pancreaticojejunostomy was created by double-layered, end-to-side, duct-to-mucosa anastomosis between the primary pancreatic duct and jejunal wall. The outer layer consisted of the residual pancreatic parenchyma and the seromuscular layer of the jejunum. An interrupted suture technique utilizing 4-0 monofilament polyglyconate was used to complete the pancreatic duct and jejunal mucosa anastomosis. A nelaton stent 6f was inserted into the pancreatic duct and jejunum of each patient receiving PJ. In group B, the larger omentum was separated longitudinally over an avascular zone, and one or two omental branches of the gastroepiploic arteries were preserved using pedicle omental flaps. The omental flap was pushed between the posterior surface of PJ and the portal vein, then wrapped over the anterior surface of PJ. The omentum was rolled up and secured with a few PDS sutures.
End-to-side hepaticojejunostomy was performed using interrupted sutures on the anterior wall and continuous 4-0 monofilament polyglyconate on the posterior wall. The gastrojejunal anastomosis was performed using a linear stapler. All patients underwent pancreatico-duodenectomy with a feeding jejunostomy tube placed 50 cm distal to the gastrojejunal anastomosis, using a silicone catheter 22f. Near drains are often seen panceraticojejunal and hepaticojejunal anastomoses. On the first postoperative day, the nasogastric tube was withdrawn, and all patients were started on FJ feeds on POD2 using the bolus approach, which involves administering the feeding solution 4-6 times a day, usually in 150-200ml sessions, over the course of 15-20 minutes, most frequently via a syringe. Once the patient was able to accept an oral diet, the FJ feed was discontinued. After three weeks of surgery, all FJ tubes were removed, and oral feeding was resumed as soon as the patient showed signs of improvement. The surgical process was the same in both groups, with the exception of omental wrapping and stenting, which were only done in group B. No patient got octreotide as a preventive measure. The institutional ethics committee gave its approval to the study. Follow up CT abdomen was done in all cases in group B to assess the pancreatic stent.
The following were the study's objectives: (a) On or after the third postoperative day, the drain outflow of any detectable volume was treated as a pancreatic fistula with an amylase content larger than three times the upper normal serum amylase value.\] The pancreatic fistulae were graded according to ISGPF standards. According to surgical site infection (SSI) guidelines, (b) a high bilirubin content leak that lasted longer than five days and was observed in biliary fluid was classified as bile leakage; (c) an intra-abdominal abscess was diagnosed based on a culture-positive purulent collection and wound infection;(d) According to the International Study Group of Pancreatic Surgery (ISGPF) criteria, bleeding that happened within 24 hours of the index procedure was classified as early post-pancreatectomy hemorrhage, while bleeding that happened beyond that time was classified as late post-pancreatectomy hemorrhage; (e) The length of hospital stay was calculated as the day of surgery till the day of discharge from the hospital; (f) Postoperative mortality was the number of deaths that occurred within the hospital admission period or within 30 days after surgery; and (g) delayed gastric emptying was identified when the patient's nasogastric tube was left in place for three postoperative days, when the necessity for its reinsertion emerged after that day, or when the patient lost the ability to digest solid food after the seventh postoperative day.
Postoperative complications were categorized using the criteria established by Clavien and Dindo. The existence or lack of POPF was the main study's endpoint. The duration of hospital stay, the rate of complications overall, and the rate of surgical death were the secondary end goals.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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A double-layered, end-to-side pancreaticojejunostomy without stenting and omental patch
Pancreaticojejunostomy without stenting and omental patch
A traditional pancreaticoduodenectomy with pylorus preservation was performed on each patient. A pancreaticojejunostomy was created by double-layered, end-to-side, duct-to-mucosa anastomosis between the primary pancreatic duct and jejunal wall without stenting or omental patch.
A double-layered, end-to-side pancreaticojejunostomy with stenting and omental patch
Pancreaticojejunostomy with stenting and omental patch
A traditional pancreaticoduodenectomy with pylorus preservation was performed on each patient. A pancreaticojejunostomy was created by double-layered, end-to-side, duct-to-mucosa anastomosis between the primary pancreatic duct and jejunal wall, a nelaton stent 6f was inserted into the pancreatic duct and jejunum of each patient receiving PJ. The larger omentum was separated longitudinally over an avascular zone, and one or two omental branches of the gastroepiploic arteries were preserved using pedicle omental flaps. The omental flap was pushed between the posterior surface of PJ and the portal vein, then wrapped over the anterior surface of PJ. The omentum was rolled up and secured with a few PDS sutures.
Interventions
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Pancreaticojejunostomy without stenting and omental patch
A traditional pancreaticoduodenectomy with pylorus preservation was performed on each patient. A pancreaticojejunostomy was created by double-layered, end-to-side, duct-to-mucosa anastomosis between the primary pancreatic duct and jejunal wall without stenting or omental patch.
Pancreaticojejunostomy with stenting and omental patch
A traditional pancreaticoduodenectomy with pylorus preservation was performed on each patient. A pancreaticojejunostomy was created by double-layered, end-to-side, duct-to-mucosa anastomosis between the primary pancreatic duct and jejunal wall, a nelaton stent 6f was inserted into the pancreatic duct and jejunum of each patient receiving PJ. The larger omentum was separated longitudinally over an avascular zone, and one or two omental branches of the gastroepiploic arteries were preserved using pedicle omental flaps. The omental flap was pushed between the posterior surface of PJ and the portal vein, then wrapped over the anterior surface of PJ. The omentum was rolled up and secured with a few PDS sutures.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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Theodor Bilharz Research Institute
OTHER
Responsible Party
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Mahmoud Rady
MD, Lecturer of general surgery
Locations
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Theodor Bilharz Research Institute
Giza, , Egypt
Countries
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References
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Ohwada S, Ogawa T, Kawate S, Koyama T, Yamada T, Yoshimura S, Sato Y, Tomizawa N, Ohya T, Morishita Y. Omentoplasty versus no omentoplasty for cervical esophagogastrostomy following radical esophagectomy. Hepatogastroenterology. 2002 Jan-Feb;49(43):181-4.
Smits FJ, Molenaar IQ, Besselink MG, Busch OR, van Eijck CH, van Santvoort HC; Dutch Pancreatic Cancer Group. Management of postoperative pancreatic fistula after pancreatoduodenectomy: high mortality after completion pancreatectomy: Reply to: Bressan et al. completion pancreatectomy in the acute management of pancreatic fistula after pancreaticoduodenectomy. HPB (Oxford). 2018 Dec;20(12):1223. doi: 10.1016/j.hpb.2018.05.015. Epub 2018 Jun 22. No abstract available.
Kolbeinsson HM, Chandana S, Wright GP, Chung M. Pancreatic Cancer: A Review of Current Treatment and Novel Therapies. J Invest Surg. 2023 Dec 31;36(1):2129884. doi: 10.1080/08941939.2022.2129884. Epub 2022 Oct 3.
Shah OJ, Bangri SA, Singh M, Lattoo RA, Bhat MY. Omental flaps reduces complications after pancreaticoduodenectomy. Hepatobiliary Pancreat Dis Int. 2015 Jun;14(3):313-9. doi: 10.1016/s1499-3872(15)60372-1.
Nikfarjam M, Kimchi ET, Gusani NJ, Shah SM, Sehmbey M, Shereef S, Staveley-O'Carroll KF. A reduction in delayed gastric emptying by classic pancreaticoduodenectomy with an antecolic gastrojejunal anastomosis and a retrogastric omental patch. J Gastrointest Surg. 2009 Sep;13(9):1674-82. doi: 10.1007/s11605-009-0944-1. Epub 2009 Jun 23.
Alverdy JC, Schardey HM. Anastomotic Leak: Toward an Understanding of Its Root Causes. J Gastrointest Surg. 2021 Nov;25(11):2966-2975. doi: 10.1007/s11605-021-05048-4. Epub 2021 Jun 7.
Elmeligy HA, Azzam AM, Ossama Y, Rady M. New technique of end to side two layered and stented duct to mucosa pancreaticojejunostomy with omental wrapping during Whipple operation. BMC Surg. 2025 May 9;25(1):201. doi: 10.1186/s12893-025-02893-x.
Other Identifiers
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PT (659)
Identifier Type: -
Identifier Source: org_study_id
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