Clinical trial · Interventional
Open Versus Total Laparoscopic Pancreaticoduodenectomy
Total Laparoscopic Versus Open Pancreaticoduodenectomy: a Prospective Comparative Clinical Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to learn more about Total Laparoscopic pancreaticoduodenectomy ( TLPD ) which is performed for participants with pancreatic tumors using the laparoscope. TLPD is an operation that includes excision of the tumor with adjacent parts of the head of the pancreas, the duodenum and the part of the external biliary system . In the final step during surgery, and to reconnect the bowel after excision of the tumor, multiple anastomoses or connections will be made by the surgeon. To get valid results , the investigators performed this randomized controlled trial that compare TLPD with the traditional technique used to remove these tumors through open pancreaticoduodenectomy ( OPD ). The main questions this study aims to answer are: Is TLPD superior to open pancraticoduodenectomy ( OPD ) regarding the adequacy of surgical tumor excision ? Is TLPD lower than OPD regarding the early complications after surgery ? Researchers will compare participants receiving TLPD with participants receiving OPD regarding : The time of the operation. The amount of blood lost during surgery. Complications that may happen during or after surgery. Time of recovery after surgery. Duration to amputation. Duration of hospital stay. The adequacy of resection .
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Laparoscopic Pancreaticoduodenectomy | — | UNRESOLVED | — |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Whipple Operation | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OPD open pancreaticoduodenectomy | Procedure | — | UNRESOLVED |
| TLPD total laparoscopic pancreaticoduodenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TLPD
- description
- This is the group that will receive laparoscopic pancreaicoduodenectomy trocars were inserted (between 5 and 6 trocars were required) and pneumoperitoneum induction was done. The surgeries were performed as previously described . Single loop reconstruction was adopted which involved the formation of all three anastomoses (pancreatico-jejeunostomy, hepatico-jejeunostomy, and gastro-jejeunostomy) on a single jejunal loop. The distance between the hepatico-jejeunostomy, and gastro-jejeunostomy was adjusted at 60 cm for all patients.
- interventionNames
- Procedure: TLPD total laparoscopic pancreaticoduodenectomy
- type
- ACTIVE_COMPARATOR
- label
- OPD
- description
- this group will receive open PD In the OPD group, a bilateral abdominal subcost incision was performed for open surgery
- interventionNames
- Procedure: OPD open pancreaticoduodenectomy
Primary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Patients presenting to the outpatient clinic of Kasr Alainy Hospitals with pancreatic head tumors, duodenal tumors, ampullary, or periampullary tumors who were candidates for either open or laparoscopic pancreaticoduodenectomy * Patients who accepted to participate in the study. Exclusion Criteria: * Patients who were deemed inoperable or irresectable tumors by preoperative investigations. * Patients with history of previous laparotomies. * Patients with complex ventral hernias.
References
Publications (1)
- DERIVEDMostafa MS, Hamour D, Aiad GAN, Balamoun HA, Khattab MH, Shazly MN, Nageeb ME, Mohamed AAA. Laparoscopic versus open pancreatoduodenectomy: a pilot randomized trial in a developing African country. Surg Endosc. 2026 Feb;40(2):1641-1650. doi: 10.1007/s00464-025-12377-x. Epub 2025 Dec 4. PMID 41345531