Clinical trial NCT06630910: New Technique of Pancreaticojejunostomy During Whipple Operation
Official title: New Technique of End to Side Two Layered and Stented Duct to Mucosa Pancreaticojejunostomy with Omental Wrapping During Whipple Operation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Periampullary Carcinoma Resectable
Pancreatic Tumors
Duodenal Neoplasms
Keywords: pancreaticoduodenectomy
omental flaps
whipple operation
periampullary neoplasms
Lead sponsor: Theodor Bilharz Research Institute
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Following pancreaticoduodenectomy, omental flaps around the pancreatic anastomosis can lower the risk of pancreatic fistula, post-pancreatectomy bleeding, and delayed gastric emptying. The overall morbidity following pancreaticoduodenectomy can be decreased with this straightforward and efficient treatment.

Detailed description: A prospective analysis was conducted on the medical records of 48 patients who underwent pancreaticoduodenectomy at our institute for periampullary cancer between March 2022 and March 2024. A total of 24 patients who had undergone pancreaticoduodenectomy without a stent or omental wrapping around the pancreatic anastomotic site made up group A, while 24 patients who had undergone pancreaticoduodenectomy with a stent inside and omental wrapping made up group B. Patients with resectable tumors of the duodenum, ampulla, distal common bile duct, and pancreatic head met the inclusion criteria. Irresectability criteria (such as metastases, ascites, or arterial vascular invasion) were among the exclusion criteria.

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.

Eligibility criteria: Inclusion Criteria:

Resectable tumors of the duodenum, ampulla, distal common bile duct, and pancreatic head.

Exclusion Criteria:

Irresectability criteria (such as metastases, ascites, or arterial vascular invasion)

Primary outcomes:
measure: The rate of pancreatic fistula after pancreaticoduodenectomy
timeFrame: 4 weeks postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Theodor Bilharz Research Institute
Study officials:
References:
citation: 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.
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citation: 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.