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Periampullary Carcinoma ResectablewhippleNCT06630910

New Technique of Pancreaticojejunostomy During Whipple Operation

A study testing Pancreaticojejunostomy without stenting and omental patch and Pancreaticojejunostomy with stenting and omental patch in people with Periampullary Carcinoma Resectable and Pancreatic Tumors, run by Theodor Bilharz Research Institute at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Pancreaticojejunostomy without stenting and omental patch and Pancreaticojejunostomy with stenting and omental patch
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteEgypt
Study dates
10 Mar 2022to 10 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Resectable tumors of the duodenum, ampulla, distal common bile duct, and pancreatic head.
  • ASA I, II.

Who cannot join

  • Irresectability criteria (such as metastases, ascites, or arterial vascular invasion)
  • ASA III, IV.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Theodor Bilharz Research Institute

    Giza

Other trials in Egypt

About this study

Official title: New Technique of End to Side Two Layered and Stented Duct to Mucosa Pancreaticojejunostomy With Omental Wrapping During Whipple Operation

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.

Read the 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.

Being tested
Pancreaticojejunostomy without stenting and omental patch, Pancreaticojejunostomy with stenting and omental patch
Keywords
pancreaticoduodenectomy, omental flaps, whipple operation, periampullary neoplasms
Medical subject headings
Pancreatic Neoplasms, Duodenal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pancreaticojejunostomy without stenting and omental patchProcedure or surgery

    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 patchProcedure or surgery

    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.

Study groups in NCT06630910
Study groupRoleWhat they receive
A double-layered, end-to-side pancreaticojejunostomy without stenting and omental patchActive comparatorNot described
Receives: Procedure: Pancreaticojejunostomy without stenting and omental patch
A double-layered, end-to-side pancreaticojejunostomy with stenting and omental patchActive comparatorNot described
Receives: Procedure: Pancreaticojejunostomy with stenting and omental patch

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The rate of pancreatic fistula after pancreaticoduodenectomy

    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.

    Measured: 4 weeks postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2024
  2. Study start10 Mar 2022
  3. Primary completion5 Mar 2023
  4. Study completion10 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06630910
Sponsor's protocol ID
PT (659)
Acronym
whipple
Status last verified
Oct 2024
First submitted
5 Oct 2024
Last updated
31 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The data will be shared upon request from the principle investigator.

Publications

  • 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.

    PubMed 11941948
  • 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.

    PubMed 29941289
  • 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.

    PubMed 36191926
  • 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.

    PubMed 26063034
  • 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.

    PubMed 19548039
  • 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.

    PubMed 34100248
  • 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.

    PubMed 40346483

Questions about this trial

What is this clinical trial studying?

A study testing Pancreaticojejunostomy without stenting and omental patch and Pancreaticojejunostomy with stenting and omental patch in people with Periampullary Carcinoma Resectable and Pancreatic Tumors, run by Theodor Bilharz Research Institute at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The rate of pancreatic fistula after pancreaticoduodenectomy (time frame: 4 weeks postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06630910, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.

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