New Technique of Pancreaticojejunostomy During Whipple Operation

NCT06630910 | Completed DMC

• 1 other identifier: PT (659)
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Tumors; Duodenal Neoplasms; Periampullary Carcinoma Resectable

Keywords

pancreaticoduodenectomy; omental flaps; whipple operation; periampullary neoplasms

Outcome Measures

Primary Outcomes (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.

  4 weeks postoperative

Study Arms (2)

A double-layered, end-to-side pancreaticojejunostomy without stenting and omental patch

ACTIVE COMPARATOR

Procedure: Pancreaticojejunostomy without stenting and omental patch

A double-layered, end-to-side pancreaticojejunostomy with stenting and omental patch

ACTIVE COMPARATOR

Procedure: Pancreaticojejunostomy with stenting and omental patch

Interventions

Pancreaticojejunostomy without stenting and omental patch PROCEDURE

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 without stenting and omental patch

Pancreaticojejunostomy with stenting and omental patch PROCEDURE

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.

A double-layered, end-to-side pancreaticojejunostomy with stenting and omental patch

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Theodor Bilharz Research Institute: lead

Study Sites (1)

Theodor Bilharz Research Institute

Giza, Egypt

Location

Related Publications (7)

• 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.

  PMID: 11941948 RESULT

• 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.

  PMID: 29941289 RESULT

• 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.

  PMID: 36191926 RESULT

• 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.

  PMID: 26063034 RESULT

• 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.

  PMID: 19548039 RESULT

• 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.

  PMID: 34100248 RESULT

• 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.

  PMID: 40346483 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms; Duodenal Neoplasms

Interventions

Pancreaticojejunostomy; Stents

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Duodenal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures; Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Lecturer of general surgery

Study Record Dates

• First Submitted: October 5, 2024
• First Posted: October 8, 2024
• Study Start: March 10, 2022
• Primary Completion: March 5, 2023
• Study Completion: March 10, 2024
• Last Updated: March 31, 2026

Record last verified: 2024-10

Locations

EG (1)